Multiregional Clinical Trials 92 ASSOCIATION NEWS 54 Upcoming Events 100 Election Results 103 Disclosure: What Is It and Why Do You Have to Do It? PATIENT PERSPECTIVE

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GLOBAL FORUM GLOBAL erapeutics ECS, Inc. PharmaNet Sarah Powell Potomac, MD Potomac, omson Reuters omson Editor-in-Chief GlaxoSmithKline Th Managing Partner Cellona Th Cellona Nancy Smith, PhD D. Shanghai University of Shanghai University Qingshan Zheng, PhD Decision Analytics, LLC Chinese Medicine, China Richard Chamberlain, PhD Jean H. Soul-Lawton, DPhil Betty R. Kuhnert, MBA PhD, Beth MBA Lowenthal, PharmD, Ronald D. Fitzmartin,Ronald D. MBA PhD, Andrzej Czarnecki, DSc PhD, MD, EditorialGlobal Board Forum orts orts e erent erent ese erent erent erences erences Worldwide Activities Worldwide have intensifi ed eff their intensifi have Global the and its successor, erent continents. We presented continents.erent We or the pastor the several years, DIA the Forum Forum, ort follows the association’s concept concept ort association’s the follows erences has a great impact on the

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of working with regulators, academics, and industry the throughout countries in many a lot has seems quite been that It world. achieved is still time, but there during that constant go, not only due to to a long way to due development, extent a large but to distinctive diff some rather to address importantto issues in diff geographies, on a problems presenting broader scale but also on a “local” level. Th ingrained in various in diff cultures locations, populated largely of them many with history a long Th and culture. diff erences, whether in language, history, diff nances, factors or other that well-being, fi make up everyday be to have life, recognized and incorporated all into activities.c and commercial Over scientifi pastthe few years, published have we a series of articles clinical on conducting trials on diff issues arising use from the of many languages, even same country within the or region, emphasizing importance the of also drew correct translations. We erences, due in diff cultural to attention casesmany traditions, to societal and language. Th organization, history, correct or incorrect understanding of these diff perception and presentation of informed as as well consent, example, in the for kind of information, provision of any high-techespecially of climate in today’s change and progress.rapid F

EDITOR-IN-CHIEF ANDRZEJ CZARNECKI ANDRZEJ 2 OPEN FORUM

GLOBAL FORUM to go through both sections at asinglesitting. to gothrough sections both theme, itmayworthwhile interested so for those be information addingto ofthe the content scope ofthe provide the articles section, Practices” In the “Best for this ofarticles. editor group section as served example. We who Kuhnert, wouldlike to thank Betty ourpast following infutureissues, articles individual ofinterestof topics this within theme through to abroader scope address wehope this perspective, spacethe available limited inasingleissue.From whichisunderstandable given of this broadtopic, cover aspects onlysome inthis section articles six is “Working inaMulticultural Environment.” Th Th emain themeof thisissueof the thatunderstanding exist areas. inthese the and diversityofperceptions and seeing America andSouth Africa, inAsia, populations work on conducting important by epidemiologists example, situations experienced these have been issue oractivity, itscientifi be mayregion have adifferent ofthe perception same at the inaspecifi sametimeabroaderpopulation andmany andof ourassociation other platforms, platform voluntary well theso within independent alloverthemany from world cooperate individuals activity. Th bediffi can is so when recognize cult to byaspecifi implication triggered an unexpected outcome in,there or mayasurprising factored be approach Ifanadjusted isnot location. and its diffbe society onthe particular depending erent, to that may making anyneed ordecision practices We to remember andneed have learned already Upcoming SpecialFocus Sections section andourspecialfocus sections. to write and/or solicitarticlesfor our“Best Practices” In additionwe are lookingfor authorsandsectioneditors the Editorial Board. interested inco-operating/working withthemembersof The GlobalForum islookingfor individualswhoare Would you like to beapartoftheGlobalForum? Call for Contributors 2011 2010 ~ ~ ~ ~ April-Harmonization February-Biosimilars December-Health Care Policy Wrap-up October-Informing &Involving thePatient c orcommercial. For Global Forum e c c [email protected] managing editor, Fran Klass, at Forum iswelcome to contact the the future direction of theGlobal to the content orinfluencing Anyone interested incontributing relaxing reading ofthe reading relaxing that enjoy the Ihope youwill the Annual Meeting, amount ofinformation to delivered usduring vast At the endofthe summer, the having digested after through their work ladder. to intheir otheruseful progress members Ingemar’sfrom professional life that could be or scientifi learned there to issomething be c, itregulatory, be environment, industry,any DIA in forpharmacoepidemiology. always those As specifi management and ofrisk inthe areas cally environment,his impact onthe EUregulatory isaware of for alongtime,butnoteveryone greatly valued been has pharmacoepidemiology Hiscontribution to environments. and regulatory the scientifi inboth career enjoys awell recognized profi IngemarPersson, Professor le presents who who follow our“Profi feature.les” Th wehave ofreaders acquiredagroup the years, Over accessible. globally knowledge continuesways to inwhichDIA help this bymaking their implementation the across world, andthe of scientifi treatments and ofnew c development It to the understand allowsindividuals goals also decades. than much inprevious faster technology access and toinscience informationprogress makes together. andideas people bringing Today’s rapid the “old” computer, basic help agreat in been has notto through mention Internet access, media social mobilephones, EDC, eg, tools, our everyday Th somanyseen in of development of e electronics, GF. ■ is month’s c 3 PRESIDENT’S MESSAGE

GLOBAL FORUM GLOBAL ■ DIA Vision onsite and online educationalonsite programs, print and digital publications, collaborative and the sharingnetworking and information from as a virtual, but non-degreewhich they grow, which now makes evenconferring, university, to readily available more information more areas in more of the of our constituents more ever than world before. DIA is an organization of advanced learning and academic highest the degree to committed of integrity, transparency we and ethics. Like a university, most the challenging where issues place the are discussedare by an engaged and debated group and future leaders.of current A special section issue focuses in this on the which we all environment work multicultural Betty increasingly I also share. wish Dr. thank to Kuhnert, who served as section, editor this for and every special this to who contributed author section workplace. on our multicultural the I also have As a practicing physician, distinct privilege of experiencing first-hand benefitsthe of our collective efforts that patients, delivered to are our ultimate customers. we live and work Although global market,in one common patients same needs they the where have no matter we work,live or where the and we have increased all. The them to same obligation participation groups of patient in our annual MeetingEuroMeeting and Annual helps to our vision be us that may global, remind but vision individuals help in that to we execute need wherever they be. may the Globe raise the level worldwide.raise well-being of health and Greetings from Around from Around Greetings erent disciplines, erent

rey Sherman, rey rst Executive Committee DIA is forum exchange for knowledge the global that fosters to innovation

c region, DIA and Europe. electing noted during his plenary remarks, this DIA during plenary President the session that opened Meeting Annual our recent in t was be an honor to introduced as genuinely

global growth is continued is important I Washington, DC, especiallyWashington, stage the with share to and hear insightful remarks the delivered by FDA during her Hamburg Margaret Commissioner Dr. Keynote Address. When diff educational backgrounds, professions, and cultures, Meeting, in our Annual together all come of collective display impressive it is a tremendously to all our speakers, ank you exhibitors, purpose. Th session chairs, tutorial instructors, and, of course, beginningour program committee, with Program Gaby Danan, who worked to tirelessly Chair Dr. andprovide us with such a comprehensive agenda.expansive Jeff I also wish Dr. thank to now our Immediate Pastnow our Immediate President, his not only for Meetingkind remarks Annual from the podium his yearsbut for of dedication our association. to His kindness and expertise been have invaluable. Jeff As strategic plan and its position as a DIA’s to one means association.professional that It evenmight view DIA, prism the of our through recent leadershiprecent transition represents a truly growth of our international in the historic moment fi association, the marking comprised of a DIA past president, current who representpresident, president and incoming continents: North America,erent the three diff Asia/Pacifi continent Australian from the rst President its fi development,further discovery, how the illustrates regulation, and marketing of biopharmaceutical products and devices become have truly global enterprises. Th RICHARD DAY RICHARD Publishing Information Global Forum Staff Paul Pomerantz Executive Director Andrzej Czarnecki, MD, PhD, DSc, Editor-in-Chief Lisa Zoks, Editor Fran Klass, Managing Editor 103 Chris Slawecki, Senior Copywriter Joe Krasowski, Marketing Communications Manager Pat Friia, Joyce Litwin Zimmerman OPEN FORUM Freelance Writers Mission 1 Worldwide Activities The Global Forum provides a multidisciplinary, neutral forum Andrzej Czarnecki for communicating information related to drug development PRESIDENT’S MESSAGE and lifecycle management on a global basis. The Global Forum disseminates content that is relevant to members’ professional 3 Greetings from Around the Globe experiences, including international industry and regulatory updates and news of the association and its programs. Ric Day The magazine is circulated six times a year as a benefi t of EXECUTIVE DIRECTOR’S MESSAGE DIA membership. Publishing, Subscription, and Advertising Offi ces: 6 Building on DIA’s Past to Move Forward Drug Information Association (DIA), 800 Enterprise Road Paul Pomerantz Suite 200, Horsham, PA 19044-3595, USA. Contact Information BEST PRACTICES Worldwide Advertising Sales, Steve Everly 267 893 5686 Subscription Information, Customer Service 215 442 6100 8 Working with Cross-cultural Teams Membership Services, Mike McGovern 215 442 6129 Iain Jessup Senior Marketing Manager, Mike Keller 215 442 6173 10 EDC Achieved: What New Challenges Did it The Global Forum (ISSN: 1944-1991) is a publication of the Reveal and What’s Next? Drug Information Association. Editorial Offi ce: Drug Information Simon Brooks Association (DIA), 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, USA; phone: 215 442 6100; fax: 215 442 13 Clinical Data Management - Pharma’s Cinderella? 6199. Copyright © 2010, Drug Information Association. Ron Fitzmartin and John Wise The Global Forum (ISSN: 1944-1991) is published six times a year, in February, April, June, August, October, and December. SPECIAL SECTION: WORKING IN Periodical postage paid at Horsham, Pennsylvania, and A MULTICULTURAL ENVIRONMENT additional mailing offi ces. Thirteen dollars of each member’s annual membership fee is for a year’s subscription. Prices 16 Working in a Multicultural Environment-Cultural include postage and are subject to change without notice. Notify Dimensions–Th e Bottom of the Iceberg DIA eight weeks in advance of address change with a copy Betty R. Kuhnert, Section Editor of the mailing label. Back issues of most previously published issues are available from DIA. 20 Manners and More! Importance of cultural PUBLICATIONS MAIL AGREEMENT NO. 41103506 sensitivity when medical writers work with RETURN UNDELIVERABLE CANADIAN ADDRESSES TO authors from the Asia-Pacifi c region CIRCULATION DEPARTMENT, PO BOX 1051, FORT ERIE, Julie A. Ely, Rebecca A. Lew, and Karen L. Woolley ONTARIO L2A 6C7 Global Forum, 26 Th e Intersection of Business and Culture in the Postmaster: Send changes of address to 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, USA. Asian Medical Markets Ames Gross Cover photo: ©istockphoto.com. DIA is a neutral organization that does not advocate for or against 29 Culture and Its Impact on Team Eff ectiveness any issue. The views expressed by the individual authors or Ira Asherman and Catherine Mercer Bing interviewees in the Global Forum are theirs and do not necessarily represent the views of the Drug Information Association. 4 GLOBAL FORUM 34 Impact of Culture and Language on Global 74 Upcoming November 2010 Meetings Clinical Trials in Paris: Orphan Drugs and HTA Inna Kassatkina, Stacy Liechti, and Mark Opler 76 DIA/EFGCP Workshop on PV Audits and 38 Working in a Multicultural Environment- Inspections-Sharing Experience and An American’s Personal Refl ections Strengthening of Mutual Understanding R. L. Chamberlain Monika Pietrek 78 Geneva to Host EuroMeeting 2011 REGULATORY UPDATES Japan 41 Submission Planning and Communication Sarah Powell 79 Interview with Dr. Masaru Iwasaki 81 1st DIA Cardiac Safety Workshop PROFILE in Japan Maki Ito 45 Ingemar Persson REGIONAL REPORTS India 83 Young Professionals Chapter Opens North America 84 On Location: Bangalore 48 Annual Meeting Orchestrates “New World” Symphony 89 Conference Focuses on Global 51 Student Poster Awards Presented in DC Regulatory Changes, Challenges 52 Images from the Annual Meeting China 56 Th e 46th DIA Annual Meeting: A Student’s Perspective 90 2nd DIA China Annual Meeting 58 On Location: Ottawa CAREER TIPS 66 8th Annual Canadian Meeting: Fostering Innovation & Access 92 Telework: It’s Working for Employers 68 Annual Meeting Focus on Pediatrics and Employees 70 Pediatric Research Program Q&A PROGRAM NOTES Europe 97 4th European Forum for QPPV Brian Edwards 72 Clinical Forum 2010 98 Annual Meeting Session Report: Multiregional Clinical Trials 92 ASSOCIATION NEWS 54 Upcoming Events 100 Election Results 103 Disclosure: What is it and why do you have to do it? PATIENT PERSPECTIVE

104 A Research Professional Learns First- hand What Matters Most to Patients 106 MARKETPLACE 107 MEMBERS ON THE MOVE GLOBAL FORUM 5 6 EXECUTIVE DIRECTOR’S MESSAGE

GLOBAL FORUM

PAUL POMERANTZ program committee overlappingprogram to minimize work the with we will care, ofhealth landscape ofinterest the andmirror areas changing new For to incorporate start-ups. DIA and successful large multinationalinstitutions, corporations, research including top-level innovation, product held June hometo medical 19-23inChicago, it’svision, appropriate be 2011will that DIA With component ofournew akey innovation platformgreat to buildonfor the future. ussignifi gives meeting cant momentum anda Th devices. and medical esuccess of the2010 outcomes health suchas related areas to new promote around current issues more discussion traditional breadthbutalso anddepthoftopics DIA’s buildupon whichwill Annual Meeting, We planning next have year’s started already actively embracingthis evolution. weare the with information itneeds, sector that the care provide health organization can eff to andproductive remain arelevant orts Inour evolved. has innovation and medical the therapies world ofregulated products, andcombination medicines personalized With years. few the the of last introduction come underconsiderablehas debate over that anarea professionalcare relationships, andindustry-health inother countries; policy care ofhealth one that aspect isanimportant a relatively phenomenoninthe USbut new comparative eff whichis research, ectiveness on includingsessions features, new some andadded Annual Meetings traditions ofpast Thyear’s is upon event thestrong built exceptional quality. of committee, anAnnual whocreated Meeting andtheGaby Danan entire volunteer program I like to especially thank ChairDr. Program like to especially I’din this year’s Annual Meeting. 46th DIA towant thank allofyouwhoparticipated to MoveForward Building onDIA’s Past be taken in Asia. Th inAsia. taken be erefore, will continue we to consider should important what direction extremely moves development quickly, it is ofpharmaceutical a timewhenglobalization At at the Annual meeting inaugural Meeting. whichheld its Committee, Steering Strategic through the America formation ofa Latin WeEast. planto strengthenourpresence in andthe Middle conferences Africa inSouth demonstrated byourrecent as front, global more ontheIn addition,weare engaging representation at nextagency year’s meeting. event—and global weplanonbuildingupon Th truly aglobal is Meeting DIA Annual e • • • • 2011will: DIA topics. on relevant content sessions engaging andcreate succinct, and diagnostics vaccines, outcomes, real-world devices, eff medical outcomes, health ectiveness, comparative suchas related areas to new ofcurrent issues including discussion andrelated products, devices, medical management ofpharmaceuticals, life cycle intheinvolved and discovery, development, aninvaluable forProvide forum professionals related products and ofpharmaceuticals and surveillance safety throughresearch postmarketing preclinical from and depthoftopics, DIA’sBuild upon traditionalbreadth patient andoutcomes care andultimately innovation impact positively Facilitate to exchange the knowledge needed allcontinents from agencies regulatory and patient representatives, clinicians, professionals, together industry Bring 7 EXECUTIVE DIRECTOR’S MESSAGE

■ ese ese GLOBAL FORUM GLOBAL . I would like to . I would like to Forum Global Wednesday SeptemberWednesday 15. Th Advancing Pediatric Research US (October Pediatric Advancing the in 12, 2010 in Bethesda, MD) in BiomedicalInvesting Drug Informatics for Development Care and Health (October 13, 2010 MD) Harbor, in National Drugand Pediatric SafetyMaternal Symposium (October 13, 2010 in Bethesda, MD) (October Cardiac European Safety4th Conference France) 25, 2010 in Nice, Direction Orphan for Drugs in Europe Future (November 3, 2010 in Paris, France) - DIA/FDA Orphan Drug Designation Workshop (November 4, 2010 in Lansdowne, VA) Right Products the Combination - Finding Regulatory Strategy (November 9, 2010 in Zurich, Switzerland) thank Dr. Betty Kuhnert, who served Dr. thank as editor this for important special section. DIA our in amount has a tremendous accomplished our adapt 46 years. to continue But we now must competencies,culture, and processes meet to your needs achieve and to our lofty goals. I look forward to working with our Board of Directors, our new Board and you, our members, to Ric Day, Dr. President answer some pressing questions of the we all face. • • • • • • • increasingly global In keeping with DIA’s nd a group of articles on you will fi concentration, several aspects environment work of our multicultural issue of the within this ect this this ect erings for for erings Development of Type 2 Diabetes Mellitus Drugs: 2 Diabetes Mellitus Development of Type Art of the CardiovascularState Safety Assessments DC)(October 5, 2010 in Washington, DIA Is Seeking Research Grant Proposals & Event the public t meansthe Programthe DIA is by which Philanthropy supports e charitable that causesbenefi Th and help to fulfi ll the mission, vision, and social responsibility of the Association as a nonprofi t Section 501(c) mission, vision,ll the and social responsibility Association of the as a nonprofi fulfi to and help c organization. research DIA for applications is accepting charitable, educational, and scientifi (3) tax-exempt grants Program and event until DIA grants the through Philanthropy include education through the exchange of information and ideas for the improvement of society and ideas of information improvement through the for exchange include education the through use of, pharmaceutical proper products; and the and appropriate to, access greater they also encompass better ts of such products drug through development and research. understanding health and economic of the benefi form, download your browser: paste URL application this a PDF of either into http://www.diahome.org/ To en/AboutDIA/CommitteeList/StandingCommittees/PhilanthropyCommittee Please direct inquiries any on these subjects [email protected]. to biotechnology, pharmaceutical, academic,biotechnology, and regulatory DIA world. the around professionals EduNeering’s Kaplan to access now have constituents solutions. EduNeering’s online compliance Kaplan eLearning educational programs provide a strong education programs and DIA’s to complement advancement. professional to commitment changing rapidly DIA be must today’s nimble in and evolve meetenvironment to all of your needs.professional Our established focus on product development, clinical research, and regulatory airs is becoming address areas broader to like aff bioinformatics, clinical safety management, and health technology assessment to as they relate fullthe cycle life of medical devices and products, pharmaceuticals, biologics, and companion a introducing end, we are this diagnostics. To number programs of in various areas refl that of productuence areas, including: confl • to strengthen our programming in Japan, China, our programming strengthen Japan, in to with programsand Korea as DIA such 7th the Japan and a MeetingAnnual from October 28-29 in Tokyo, meetingjoint with Konect in South in mid- Korea November. a diverseOur represent global group constituents of pharmaceutical and medical device development professionals, achieve to together all coming essential to are shared aspirations that professional DIA health care industry. and innovation in today’s EduNeeringKaplan announced a new have strategic online educational create off to alliance a well oiled machine. Having decided that national reputations have no foundation, I immediately bumped into a strait-laced and effi cient German at my hotel reception.

Travel and the education it provided certainly proved me wrong!

Th ere is no right or wrong way to tackle multicultural team issues, and I aim only to provide an insight from my own experiences. Most issues, however, focus around communication, how we listen and speak, and how we are perceived.

To be eff ective, communication must be clear and concise; clarity is everything. What you say, write, hear, and read may not be interpreted as what you mean, and you may have to repeat and reinforce the message in a diff erent way. Telephone and written communications are the norm for remote teams; in the current economic climate a face-to-face team meeting is a nice-to-have that does not happen very often. You need to learn how to communicate, motivate, and manage confl ict and performance across Working with borders by phone and mail. Sometimes you are lucky to meet your team. I was fortunate to work with Cross-cultural Teams European and US colleagues on a new business venture. I was based in the UK, my line manager was in the US, and I Iain Jessup was responsible for a group of managers from the UK, Th e Netherlands, he world is getting smaller serious obstacles around diff erent Belgium, Spain, France, Germany, and as a manager in pharma, understanding of expectations, Switzerland, Italy, and Sweden. Th e T you are possibly leading communication styles, and lack fi rst thing I did, (in those days we had teams with members from diverse of fl uency in the teams’ dominant the luxury of travel), was to organize a cultural backgrounds and diff erent language, or through a lack of team meeting to share the mission, the regions. Diversity in teams can foster understanding of cultural diff erences. scope of the project and as one of my innovation, promote staff retention, Understanding diff erent customs is main objectives, to get to know each increase productivity and identify important to avoid misunderstanding other. Not only were we from diff erent new approaches to problem solving. behaviors in certain situations: for cultures, but we came from two recently However, managing a multicultural example, at an investigator meeting, merged companies with very diff erent team can bring greater challenges members from a more nation company structures and styles. than managing a culturally with more formal customs may be homogeneous or co-located team. shocked to see a colleague greeting It was a fantastic opportunity for an investigator with a kiss! me to observe the understanding, As a manager, you need to be aware reactions, and behaviors of my of the cultural diversity within your It is important to avoid preconceptions. colleagues, because we brought team: there will be diff erences that Th e fi rst time I went to Berlin, I found diff erences to the communication can be a real joy and part of what that the people never stopped laughing process derived from our genders and

BEST PRACTICES working internationally is all about, and joking. Th e service in a restaurant our regional and cultural backgrounds. but these diff erences may present was indiff erent and made Italy look like While everyone was very familiar 8 GLOBAL FORUM with working in English on a daily as part of Scandinavia, and outsiders restaurant? Are there any hints basis, I noticed that for two days, one may expect both to have similar values. from the television? team member from Italy (who had However, another team meeting with been born and brought up in the UK representatives from both countries When you go to meetings, how of Italian parents) was constantly revealed such diff erences as the Finns formal are they? Is the hierarchy writing. Since there were handouts, being spontaneous, action-oriented obvious? Is there a clear decision- I questioned her about this behavior, individuals, while the Swedes preferred making process? Is there a formal and she responded as follows: to plan and contribute in a measured agenda? Is humor interjected into the way. meeting? Is there time for small talk? “I have been writing down all the words and phrases that the UK and US team Further are some stereotypes that you All of the above are opportunities to members use when speaking: need to banish right from the start: learn, but you never really learn until ‘More bucks to the pound’ you actually do the job. ‘Never look a gift horse in the mouth’ • English tend to be seen as ‘It’s a no-brainer’ standoffi sh, both at work and If you are off ered the opportunity to ‘It isn’t rocket science,’ etc.” personally. manage a multicultural team, enjoy and embrace the opportunities it brings to Although she spoke fl uent English, • Americans tend to be known as broaden your horizons. You can gain she was pointing out that many culturally self-centred. fresh perspective on your day-to-day others on the team would also be role and learn new ideas and approaches trying to interpret these “everyday” • French are intolerant of those which will aid your personal growth and terms and would have therefore not speaking French. development. Above all, it can be fun. missed the next fi ve minutes of the meeting. A really valuable learning • Germans tend to be disciplined. Th ere are a few available resources point: speak clearly and avoid the use that I would recommend: of clichés and colloquialisms. • Spanish and Italians are seen as • Harvard Business Review less disciplined, but creative. ‒ Article Reprints & A good manager must also be a good Collections listener and be able to recognize To be a successful manager it is hbr.harvardbusiness.org basic problems of communicating important to make an honest attempt across borders when one or more to understand these stereotypes by • GlobeSmart people are using English as a second acknowledging the diff erences and ‒ web-based tool on how to language. However, listening with an getting to know the team members as conduct business around the ear to regional or cultural diff erences individuals, avoiding generalizations world is a mindset. It is a decision to take and labeling people. www.globesmart.com yourself and what you are hearing out of your personal context and put it It is important to do your research • In-house cultural awareness into a diff erent context. To foster good when becoming a multicultural courses team work you will need to be patient, manager – but where should you look giving direction and asking questions, since many websites give the same • Travel–use your eyes and ears but being prepared to rephrase if formal lessons? I have found that someone does not understand. when traveling, start by attentively • If in doubt, ask. ■ looking around the destination It is fundamental as a manager to be airport as a great learning experience. a role model for respect; this rubs off on other members of the team. Th ere • How do people queue? Do they is nothing wrong in thinking of the queue – or is that just the English? other person as diff erent from you and in honoring these diff erences. • How do they greet each other? Good communication comes from Kissing, handshakes, bows? BEST PRACTICES celebrating diff erences rather than ignoring or being in confl ict with them. • How do they speak to each Be happy that your team members are other? In the taxi, what can the diff erent and don’t make assumptions. driver tell you? What are the driving standards? A good example of making assumptions is refl ected in the diff erences between • At your hotel, look around at Iain Jessup is Vice President at Finnish and Swedish people. Th ese two social interactions, how were i3 Pharma Resourcing. You can contact countries are generally lumped together you greeted at reception or the him at [email protected]. GLOBAL FORUM 9 10 BEST PRACTICES

and global in scope; incorporate incorporate inscope; and global more complex studiesbecome clinical Th analysis. andautomate with cope downstream ifyoucannot isofnovalue collection data all,faster After and reporting. for analysis andprepared reconciled, and accurately aggregated, be to quickly data sources nowneed Multipleinformation downstream. created atorrent has of EDC data, accelerating ofstudy the collection Byautomating and challenges. new paradoxically spawned has Yet, success ofEDC the very staff pharmaceutical and acceptance clinical byboth usability and scalable, increasing more to become have evolved systems EDC inherent advantages, the technology’s upon dependent companies increasingly have become pharmaceutical As costs. operational improved productivity, anddecreased delivering higherqualitydata, O management ofthe industry, tool solidifi the data preferred as itself ed has dataelectronic capture (EDC) the forefront ofthis movement, At data. clinical capture andanalyze to more effi technologies GLOBAL FORUM #H1221735, February 2010 #H1221735, February 1 Health Industry Insights, Health Industry is dilemma is only exacerbated as isdilemmaonlyexacerbated as ver the last decade, decade, ver the last have many embraced novel companies pharmaceutical alike. ciently 1 agreement thatagreement integration isthe Th ere issignifi Challenges andStrategies forSuccess benefi gained. to be ts the integration path andmaximize the able tomovedown be better will now strategies that key adoptsome organizations Pharmaceutical tasks. simplifi key ways ofperforming ed ofinteraction and single points byproviding issues these resolving route to adirect Integration provides a workfl vital. be ow perspective—will environment—both adata from and integration ofthe clinical To effi maximum achieve signifi andare of acause the industry within are understood already duplications andineffi these Many of redundant. have become that existing processes exposed or duplicatecreated processes instances, insome has, technologies Thetc.). new of e introduction ePRO, IVRS, EDC, (eg, technologies complex multiple studiesemploying track andmanagedata across stafffor sponsor s to effi isthe need andprocesses systems development onclinical stress thisCompounding data-induced builds. research clinical oninvestment return for for afaster andthe pressure escalates; scrutiny regulatory shrink; R&D budgets technologies; additional andnew cant frustration. cant industry ciently ciencies, ciencies, ciencies ciencies being delivered. delivered. being the chances ofthe benefi maximize will Addressing areas three these 3. 2. 1. benefireaping the full ofintegration: ts from organizations impede typically Th held practices. business long- to ofrevamping the challenges attributed be also itcan technologies, andexisting experimenting new with isstilladoptingand the industry diffi as expected, istoculty be ofthisto Whilesome implement. diffi to be may perceived be it yet research, future ofclinical on a solid foundationon asolid ofbusiness integrations areEnsuring based Focus onProcess ere that are core three reasons process boundaries. boundaries. process and byorganizational activities data acquisition andcleaning the from separated are often who team andstats reporting ie,theend usersofthe data, to forget theA tendency standards. adopting industry An overly approach dogmatic to integrations. or activity integrations rather than process systems-focused to-point” “point- on technology-driven, to afocus leading integrated, that are processes being business ofthe understanding Partial Simon Brooks cult cult ts processes is the fi rst step. Start by additional steps and be signifi cantly is a clear need to exchange data identifying the target process rather diff erent from that described in externally or there is a business case than the system. Activities around standard operating procedures. for using them that is compelling management of randomization and It also allows focus on new time at the individual study or program treatment allocation and recruitment dependencies that were not evident level—CDISC, lab, or E2B / HL7 are two areas well known to cause when processes were managed ICSR are areas where this is likely signifi cant problems. independently, and tracks how to be true. If adopting external the implementation of a protocol standards for areas like labs, it’s For example, the management of amendment or software change to worth remembering that even if an patient randomization and drug the underlying systems impacts the external vendor can send data in allocation is typically split between integration. CDISC Lab that doesn’t mean it’s interactive voice response systems clean. Standardizing should not lead (IVRS) and EDC systems. Th e result Technology should be introduced to a collect-and-forget approach. is duplicate processes for both sites directly after high-level processes and sponsors, and an inevitable, are defi ned, as ideally one should be When it comes to standardization labor-intensive data reconciliation looking to use as much of the standard for integration, length is better eff ort at the end of study when all integrations provided by vendors as than depth. A small number of the subject, treatment, and container possible. Once integrations become standardized items that have data is pulled, and it becomes clear established, data becomes both acceptance from all the teams that it doesn't quite match. more reliable and most importantly, between protocol development to more trusted. Th is development of submission is of more value than a With tracking of subject recruitment, trust is important as it provides the full set of standardized case report it is critical to have an accurate and route to an important additional forms with no agreement on data trusted data source so as to ensure effi ciency benefi t—the removal of the submission formats. studies do not over- or under-recruit all-pervasive spreadsheet tracking and that recruitment rates can be system. An entire cottage industry Don’t Forget the End Users quickly optimized, and problems at specializing in time-consuming By integrating processes and sites can be identifi ed and corrected. spreadsheet generation has evolved workfl ows and applying standards However, IVRS, EDC systems, and as a result of non-integrated systems (albeit pragmatically), integrated clinical trial management systems producing divergent data. As trust in and standardized data should now (CTMS) and their respective users all data develops, behaviors change and be available during the course of have their own view on recruitment personal spreadsheets will cease to the study. Th is data can provide status. IVRS data is usually available play such a critical role in managing immediate benefi t to statisticians, fi rst, but with sparse information studies. programmers, and regulatory aff airs and prone to site errors. EDC data is teams and show impact beyond the typically slower to arrive, but has the Pragmatic Approach to teams working directly on study and benefi t of being source data verifi ed Standardization data management. and tells you more about who you Standards are a critical factor are recruiting. Finally, the company in integration; however, driving Controlling this information from CTMS is populated from the IVRS standardization is diffi cult. multiple collaborators, while or EDC system and sometimes Standardization requires a change maintaining an audit trail, however, manually entered by monitors—this in behavior across a whole set of is extremely diffi cult. Access to hopefully provides the full picture, diverse stakeholders, and adopting a integrated data through a central albeit rather late. Th is duplication pragmatic benefi t-driven approach to repository during a study can BEST PRACTICES and complexity makes answering the standards adoption will increase an streamline data preparation and apparently simple question, “how organization’s chances of success. allow processes normally performed many subjects are enrolled?” time between data collection ending and consuming and error prone. Initially focus on internally defi ned analysis starting to be moved earlier standards; these are likely to be and performed “in-stream”, ie, as Running a paper-based integration easier to adopt and deliver benefi ts the study is being executed. Data simulation can also be a very valuable quicker than externally defi ned can then more easily be aggregated, strategy to identify areas where the standards. Look at the use of tracked, and transformed, and “real” business process may have external standards only where there discrepancies can be identifi ed and GLOBAL FORUM 11 reconciled earlier, improving interim focused specifi cally on clinical and processes and reducing costs. By analysis. operational study data provides for moving to a suite of applications the fi rst time an opportunity not only with existing integrations there are Th is access to integrated data, if to supply integrated data to meet a further opportunities available to matched with an integrated clinical whole range of clinical development reduce development costs, and, data repository or controlled analysis needs, but also to provide the more importantly, the headache environment, also supports the framework for single reporting, and overhead of managing early testing and running of analysis analysis and decision support unique environments and custom outputs—again providing early environments. integrations. awareness of issues with analysis programs or data. Moving to a set or suite of integrated applications from a single vendor One Integrated System can provide additional cost-saving As clinical study delivery strategies opportunities associated with become more diverse with the use of managing and supporting your onshore and off shore teams, in-house clinical systems environment. Th e staff , contract research organizations ease and cost of integration with (CROs), and joint development existing systems becomes crucial, partners, the advantage of being able and the advantage of being able to to provide a common integrated hold a single vendor accountable to environment with clear accountability deliver and maintain integrations— for support and integration is not only at initial deployment but attractive both in terms of cost and also through the inevitable software also in freeing up management time upgrades and protocol amendments Simon Brooks led global EDC and to focus on study delivery. upgrades that accompany every CTMS implementations for one of study—is enormous. the world’s top fi ve pharmaceutical Th e advent of a new generation companies, and is now overseeing of data repositories that are Th e benefi ts of integration are data and product integration at integrated with capture systems and persuasive both in streamlining Phase Forward. ■ BEST PRACTICES

12 GLOBAL FORUM Clinical Data Management - Pharma’s Cinderella?

Ron Fitzmartinin andd JohnJ h Wi Wisese Background the introduction of the T30, the response services (IVRS), and In the 1950s, Elvis Presley erupted multifunction handheld calculator patient-reported outcomes (PRO) onto the pop music scene and from Texas Instruments. Th e 1980s devices constructed using personal eventually emerged as the King of brought us “Generation X,” the digital assistants (PDAs). However, “Rock ‘n Roll.” In the 1950s, clinical children of the Baby Boomers, and paper still reigned supreme! As we data management (CDM) in the the end of the Cold War. In data entered the 2000s, we survived the pharmaceutical industry was a management the ‘80s also brought Y2K scare (incidentally giving a nascent function, and the tools us the PC, Oracle Clinical, SAS, BBN remarkable boost to India’s nascent of the trade were pen and paper. Clintrials, and remote data entry IT industry), yet CDM tools really It was such a simple time! In the (RDE). Nonetheless, pen and paper hadn’t changed much from the 1960s, youth turned traditional fi rmly remained the major tools for 1990s, and paper was again voted by values inside out. Th e Beatles came clinical data collection. the clinical development community to America and started the British as the data collection tool “most rock ‘n roll invasion, Neil Armstrong As we entered the 1990s, the likely to succeed.” stepped onto the moon, and IBM concepts that Sir Tim Berners- had introduced some of the fi rst Lee had outlined in his paper So for approximately 50 years, the mainframe computers. However, “Information Management: A tools used for CDM had focused CDM tools of the trade were still Proposal” (1) published at CERN on paper with some gradually BEST PRACTICES very much pen and paper. were realized and rapidly created increasing assistance by computers. the phenomenon of the World Th e progression from paper to RDE Th e 1970s came and the world was Wide Web. During this time, the and then to EDC has been painfully shocked by the break-up of the pharmaceutical industry still used slow and the literature is replete Beatles! But were changes underfoot the same pen- and paper-based with the reasons why. Th e risk- in the CDM world? Pen and paper CDM data collection tools. Some averse nature of biopharmaceutical were still king and queen, although companies were starting to introduce sponsors, the need for regulatory DEC and CDC computers were thick-client electronic data capture compliance and concerns about now commonplace along with (EDC) systems, interactive voice 21 CFR Part 11, immaturity of GLOBAL FORUM 13 software and cultural challenges manager has changed and the new companies could focus on their provide just some examples. In 2000 roles are clear; these new roles are core competencies. Two years Fitzmartin (2) noted that “… it has not to be defi ned just in the EDC later, the 2009 Annual Survey been 15 years since the introduction environment, but rather they are reported that 43% outsourced of the concept and use of remote being redefi ned in the wider global to focus on core competencies, data entry (RDE) at a clinical site; drug development paradigm and while 23% reported that it was however, it is unclear whether more within the discipline of Biomedical necessitated by the company being than 5% to 10% of the industry’s Informatics. virtual. In 2005 Frost and Sullivan clinical trials use electronic data (F&S) estimated that by 2010, 40% capture (EDC) technologies.” We need electricity but we don’t of Europe’s pharmaceutical R&D In 2006 Gartner reported that own the power plant! would be outsourced. In 2008, approximately 25–30% of clinical If one were to focus on the core F&S indicated that 40% of all USA trials were using EDC (3), while competence of the pharmaceutical clinical trials would be outsourced Th omson CenterWatch (2006) industry, viz the development of and that by 2013 that figure would reported that EDC was now used in drugs, it would become clear that rise to 65%. approximately 40% of clinical trials other functions such as clinical data worldwide, and by the end of 2007 management, statistical analysis The Fairy Godmother Arrives! it would reach 50% (4). According programming and execution, and Th is leads us to the conclusion that to the eClinical Forum (2009), EDC other operational components of the traditional CDM organizational is now used in 58% of clinical trials functional areas such as regulatory, structure is outdated. Th ere is no versus 13% in 2001 (5). So, it has clinical, and risk management are need for a siloed CDM department, taken the industry over 20 years essential but nonetheless supporting with data “review & validation” as since the fi rst RDE trial to get to functions. As such, these can be their primary function, to be situated the midpoint of 50% of all trials obtained from companies expert within the core pharma R&D being EDC-based. Not exactly in delivering such services with a business. rapid progress! high quality and at a competitive price. Th ese specialist companies Today in the pharmaceutical In 1998 and again in 2009, the have made the provision of these industry data are no longer “owned” Good Clinical Data Management commodity services their core by one or more groups. This data Practices (GCDMP) document competency. By simple analogy, now ranges from the traditional published by the Society of Clinical one might comment that a phenotypic data, through the Data Management (SCDM) stated biopharmaceutical company needs plethora of data types associated that “Th e discipline of Clinical Data electricity, but does it need to own with biomarkers and genotypic Management includes paper and its own power plant? Th e provision data, as well as a new wave of electronic case report form design, commodities must provide prime data coming from the health clinical trials database design and opportunities for arbitrage and as care environment. In this new programming…” Noticeably, the such for business and knowledge paradigm, data and information SCDM did not take the opportunity process outsourcing/off -shoring are viewed as an enterprise asset, to update this description to (BPO and KPO) companies to not a silo-controlled “treasure.” address how the “discipline” and penetrate pharma development. When data, information (and the associated technologies have Such outsourcing is not a indeed knowledge) are viewed changed over the past several years. trivial task; it requires in-depth as enterprise assets–available on Th e 2007 version of the SCDM’s understanding of the activity to be demand–then a new knowledge GCDMP document states that outsourced, a clearly understood management structure and “Th e role of data managers will contractual relationship, a detailed governance is required. This be changed by EDC and the new service level agreement, and senior governance transcends the roles are not yet clearly defi ned.” level relationship management. organization’s core functions, However, the 2009 version of their and takes cognizance of alliances, GCDMP states “the role of data In Contract Pharma’s 2007 Annual partners, and service providers. managers in international EDC Survey, 40% of the pharmaceutical This knowledge management trials is similar to the role played company respondents indicated organization becomes a corporate

BEST PRACTICES in paper studies.” Which view that they used outsourced- and cross-functional activity holds true? Th e role of the data based services such that their residing ideally within a corporate 14 GLOBAL FORUM R&D Biomedical Informatics a supporting (albeit essential) department. Biomedical commoditized function. It has not Informatics in global pharma significantly changed in the last 50 and health care is the scientific years and as such, CDM jobs are discipline that “optimizes the following the inexorable tide of access to and use of biomedical arbitrage and are moving offshore and healthcare information for the at a rapid pace. Biomedical benefit of public health.” (6) Most Informatics has emerged to be the major pharmaceutical companies discipline that provides the new have recognized that biomedical pharma health care company with informatics is integral to the the expertise in the optimal use delivery of an internal knowledge of data and information across management environment, and the entire R&D value chain. So if Ron Fitzmartin, PhD, MBA, is is critical to the success of the CDM is pharma’s Cinderella, then Managing Partner, Decision organization as a contributor to Biomedical Informatics is its fairy Analytics, LLC. You can contact him the global pharma health care godmother! at ronﬁ [email protected]. Ron is a information ecosystem. member of the Global Forum’s References editorial board. Summary & Conclusion 1. http://www.w3.org/History/1989/ Th e pharmaceutical industry R&D proposal.html process is broken. Th e current 2. Fitzmartin, R., Drug Information model of drug development is Journal, 2000. unsustainable. Costs have spiraled 3. Bio-IT World Conference, out of control and productivity has April 2006 plummeted. Change is essential! 4. Th omson Centerwatch (http:// www.contractpharma.com/ One change the industry is making articles/2007/05/cro-industry- is to identify the core strategic update) functions and to retain them 5. eClinical Forum (http://www. within the organization and to eclinicalforum.org/main/ outsource the others to specialist default.aspx) companies. CDM is necessary 6. Fitzmartin, R & Wise, J. DIA John Wise, MA, Th e PRISM Forum but must be recognized as just Global Forum, December, 2009 ■ Association. BEST PRACTICES

GLOBAL FORUM 15 Betty R. Kuhnert, Section Editor

Overview or dress, are at the tip of the iceberg. excellent examples of some of these Individuals can often be perceived However, what usually causes trouble cultural faux pas in the articles that as rude when they don’t mean to for those working in a multicultural follow by Ely, et al., Asherman and be because they are not aware of environment is the larger part of the Bing, and Gross. or do not understand how cultural iceberg that is under the water and diff erences aff ect their interactions not obvious. Cultural diff erences Human Relationships and decrease productivity. In “below the waterline” may be Let’s go below the waterline and response to this issue, the Global described on scales or dimensions. look at the four subcategories of Forum is presenting a group of 6 Th e major cultural dimensions the cultural dimension related to articles related to working across include how people relate to each human relationships. Diff erent cultures in the pharmaceutical other, view time, and communicate. societies relate to their own members industry. Th e articles in this series Under each of these major categories in diff erent ways. Some societies, discuss the basics of cultural are several subcategories that may many in Asia or Latin America, are dimensions (Kuhnert); the go by various names. Professionals very group oriented, whereas others importance of manners and cultural working in another culture get into such as those in North America, sensitivity (Ely et al.); the intersection trouble because they are not aware Australia, France, or the UK are of business and culture in Asian that there is more to culture than more individualistic. If you think markets (Gross); the eff ect of cultural what they can see. Th ere are some of this as a scale or dimension of dimensions as they apply to team individual to group orientation eff ectiveness (Asherman and Bing); from 1 – 10, individualistic cultures the impact of language on clinical would be closer to 1 whereas group- trials (Kassatkina et al.), and the oriented cultures would be more in personal refl ections of an American the middle of the grid or closer to 10. who lived and worked in another Accordingly, singling an individual country for years (Chamberlain). out of a work group even for good All of the articles present valuable performance would be a mistake in a information for those working group-oriented culture. It would be in any of the disciplines of the very embarrassing for the individual, pharmaceutical industry. Culture, could destroy the cohesiveness of which is often defi ned as societal the group, and could result in less norms or patterns of behavior, can productivity overall. In contrast, be very complicated and diffi cult to many other cultures would not understand. Geert Hofstede, one appreciate their salaries refl ecting the of the founders of cross cultural performance of an entire work group. research, explains culture as the “software of the mind.”1 According Cultural dimensions are also often to Hofstede, “If the brain is the refl ected in a country’s idioms or hardware, culture is the software.” It Figure: Culture as an iceberg. proverbs. Compare “Th e squeaky also helps to understand culture if Cultural diff erences that we’re aware wheel gets the grease” (US), with one thinks of it as an iceberg (Figure). of, such as language, are on top of the “Th e nail that sticks up gets pounded Cultural diff erences that are obvious, iceberg, but we’re not aware of the down” (Japan), and you can see the such as language, food, style of ones that cause most of the problems spectrum of an individualistic versus

MULTICULTURAL WORK ENVIRONMENT MULTICULTURAL greeting, exchanging business cards, because they are not obvious. a group-oriented society.

16 GLOBAL FORUM Another dimension related to turn down invitations for evening deadlines rigidly adhered to or human relationships is how activities, or want to discuss business seen only as targets to be missed, if individuals respect hierarchy. during relationship building, necessary? Does someone you work Asian cultures, French, Indian, business lunches. Moreover, very with insist that meetings start exactly and many Latin American cultures abrupt, task-oriented emails often on time, or come to meetings late are very hierarchical, whereas come across as rude if there is no with no apology? If deadlines are an North American cultures are more relationship building to soften them. issue on a multicultural project, the egalitarian or participative. For Th e article by Gross shows how project manager needs to understand example, it is common for Americans relationships are the key to doing this cultural dimension and be very to call each other, their supervisors, successful business in Asia. clear about setting expectations. and probably several higher levels In addition, the word “deadline” of management by their fi rst names Th e fi nal of the four human or “target date” may be translated as soon as they meet them. In other relationship dimensions concerns diff erently in diff erent languages. cultures, you would never call a situation vs. rules and is related to For example in French, “target date” stranger by his fi rst name, and it the previous dimension regarding may be translated either as date cible might not even be appropriate to talk relationships. Th is relates to fairness. or date butoir. Th e former is a date to someone in the company above Th ink of this as the “who you know” that might be nice to meet, but it is the level of your boss without specifi c dimension. In some cultures it is also a target that may be missed if permission. How business cards acceptable to treat people diff erently something more important comes are handled (a behavior “above the based on their individual, subjective along. Th e latter, date butoir, is a waterline”) refl ects this dimension. situations. In other words, it is more important, drop-dead date. It is In Japan, there is a very formalized sometimes okay, and might be important to be very clear on what is ritual to exchanging business cards expected, to bend the rules if you at stake. (meishi), whereas in the US it is know, or are related to someone. much more casual. Business cards In other cultures, such as the US, Another dimension related to time are much more important in a UK, and Japan the rules are usually is the importance of external control culture where you need to know more important than the situation or (fate, the past) and internal control where the person you are meeting is relationship. (the future). In your culture is on the hierarchy so you know how the past very important, or is the to address and relate to him or her. Time past just history? Th e past is more Also note that in many cultures, How groups view time is also important to cultures such as those women are still considerably lower culturally dependant and often in France, Mexico, and India, than it on any scales of hierarchy than men. refl ects the infl uence of geography is to cultures such as the US or Great Th e article by Asherman and Bing and climate. Some cultures, such the Britain. Th e importance of external provides a good example of how this US and Great Britain, see time as control in some cultures is illustrated MULTICULTURAL WORK ENVIRONMENT dimension aff ects what constitutes something that must be managed, by an old Indian proverb that states, an eff ective leader. whereas individuals from other “You can run as far and as fast as you cultures, such as France, India, or wish, but you will only get as far as Th e third dimension related to Mexico may feel that time cannot that which is ordained.” human relationships is task versus be managed. Th is monochronic/ relationship. Th is refers to the polychronic dimension might be In a business environment, the priority of task versus the priority thought of as “time fl ies” versus time dimension also relates to of relationship. Not understanding “there is always tomorrow (man~ana).” comfort with change. Some cultures this dimension may negatively aff ect Th e sun will come up and the where the past is very important the client-customer relationship. monsoons will always come, but are resistant to change, whereas Many cultures value relationships meetings may be late or might not others value change for change’s more than tasks and prefer to build happen at all. sake. If you are a manager trying to relationships before discussing manage change in a multicultural business. Most Americans, for Th is dimension may be refl ected in environment, you need to example, don’t understand this and a business environment by working understand this dimension. Other prefer to just start working. Th ey are styles. Do managers focus on one dimensions related to time refl ect often considered rude when they task at a time or multi-task? Are how long it takes to make decisions,

GLOBAL FORUM 17 sign contracts, and meeting styles. (Asia, Latin America) whereas others communication than cultures Some cultures are very comfortable are much more comfortable with such as those in the US, France, with risk, and can make decisions varying degrees of confl ict (France, or Great Britain. Th is may cause quickly, knowing that they can Great Britain, US). Th is harmony problems with video conferences make changes later. Others want versus confrontation dimension will or teleconferences where subtle everything clear and fi nal and aff ect meeting style, public behavior, nonverbal cues are missing. In don’t expect any changes after a and how information is presented. dealing with a highly nonverbal business deal is concluded. Th is may For example, meeting styles are culture, it is helpful to listen very cause problems in a multicultural very diff erent in nonconfrontational carefully, learn to “read between the environment with processes such as cultures such as Japan compared lines”, and watch for subtle gestures. change orders. to cultures more comfortable with Also, keep in mind that nonverbal confl ict. More than likely an issue behavior or hand gestures acceptable Th e process of coming to a decision has already been decided by one- in one culture may be considered is also culturally dependent. Some on-one conferences, and a formal very rude or vulgar in other cultures, cultures (Japan, Mexico, France) meeting is only to announce the for example prolonged, direct eye are more interested in process (ie, decision. Th e North American style contact, pointing with one fi nger, deductive logic) and want lots of of meeting where there is public the OK sign, or blowing your nose details than other cultures (US, India, debate and then consensus would be in public. Even smiling at strangers Great Britain), which are more results very uncomfortable to someone from could be misinterpreted. oriented (inductive logic). In business a nonconfrontational culture. meetings, the American presentation How formally or informally one style of bullet-points, executive Public behavior, (for example Asian communicates is also culturally summaries, and unsubstantiated children are often taught to hide dependant. Th is dimension is also conclusions might seem suspect to their real feelings) refl ects this infl uenced by hierarchy from the cultures needing more details. Th ose dimension, as does the use of the relationship dimension. Formality is who understand these cultures will words “yes” and “no.” “Yes” may often refl ected in languages, such as back up presentations with briefi ng mean, “Yes, I hear what you said,” Japanese, French, or German, where books sent beforehand and allow “Yes, I understand,” or “Yes, it is there are diff erent levels of formality plenty of time outside of the meeting not so.” However, “yes” may not used to address children, colleagues, for decisions to be made. mean, “Yes, I’ll do it” or “Yes, I or superiors. It is also refl ected in agree with you.” Th e word “no” may rituals, such as exchanging business Communication not be used at all, but the meaning cards, or how low one bows to one’s Th e third major cultural dimension might be conveyed by pursing the boss, or others. Americans are relates to how people in various lips or a vague, “Th at might be often perceived as rude because the cultures communicate with each diffi cult.” Saying “no” directly would American culture is much less formal other. Th is dimension probably be considered very rude and too and the concept of specifi c protocols causes more intercultural problems confrontational. One should also or rituals is not understood. Also than either the relationship or consider what “information” means not understood is the separation of time dimensions. Often, strangers or how bad news is conveyed in public versus private life. In some to a culture think they are a nonconfrontational culture. A cultures it is considered polite to communicating, when in fact they project manager might be told that ask about one’s family as you are have not communicated at all, or there is “a little problem,” but not getting to know your colleagues have totally miscommunicated, even that the whole project is way behind (US), but in many other cultures it when they know the local language. schedule. would be considered very rude in a Th e article by Kassatkina et al. work environment (France). What discusses the impact of language Th e amount of nonverbal personal information that could or on clinical trials and some of the communication is another culturally would be discussed with clinical trial problems that may arise with medical dependant dimension. An old Asian personal is also culturally dependent terms, or with informed consent. proverb says, “Th ose who know do (see the article by Kassatkina et al.). not speak, those who speak do not Some cultures have communication know.” Asian and Latin American Th e last subcategory in the

MULTICULTURAL WORK ENVIRONMENT MULTICULTURAL styles that deliberately avoid conﬂ ict cultures often use more nonverbal communication dimension is

18 GLOBAL FORUM the achievement versus balance cultures, it is just as important not country- by-country customs scale. One can think of this as the to stereotype individuals based see, “Do’s and Taboos around the “how willing are you to work on on nationality. For example, not world” edited by Roger E. Axtell, weekends” or the “work-life balance” all French like to cook, Germans 3rd edition,1993, from John Wiley dimension. Japanese and American may not always be on time, and and Sons. workers might work over a weekend very few Americans are rich, yet to meet a deadline, but workers these are common stereotypes. A 1. Hofstede, Geert & Hofstede, in France where there is a legally particular individual may behave Gert Jan, Culture and mandated 35-hour work week, very diff erently from what might Organization: Software of the would probably not. Also, in many be expected based on where his Mind, McGraw-Hill, 2005. ■ cultures, there is a strict separation country fi ts on a given cultural between one’s work life and one’s dimension. Individual behavior in private life. Project managers trying the current global environment to meet tight deadlines need to may refl ect age, exposure to other understand this dimension. How cultures, educational level, etc., as this dimension aff ects clinical much as nationality. Th e article by trials is discussed further in the Gross emphasizes this point and articles by Bing and Asherman, and how one must respect diversity in Chamberlain. Chamberlain points Asian countries, and how western out how Scandinavians just “don’t executives working in Asia might be get it” when it comes to vacations. stereotyped.

Another big issue causing Th ere are many resources available Betty R. Kuhnert, PhD, MBA, is communication problems is the to learn more about cultural the Executive Director of Training common use of local idioms and diff erences. Th e excellent table in Services at PharmaNet and sports expressions. For example the Ely et al. article on manners teaches the PharmaNet Working terms such as “end run, drop the in this series lists basic “do’s and across Cultures course for internal ball, across the board, and being don’ts”. If you would like to see staff. She has had a great deal of on the same page” probably won’t where you or your country fi t on experience living and working be understood outside the US. the spectrum of cultural dimensions across cultures and many years of Even native speakers from diff erent try the Culture Compass® at www. academic clinical research and countries may not understand each deanfosterassociates.com. To know pharmaceutical industry other. For example, the English more about what is above the experience. Betty has been active expression “to table something” has waterline on the cultural “iceberg” in DIA since 1989 and recently opposite meanings in the US and UK; for any number of countries try completed two terms as the US MULTICULTURAL WORK ENVIRONMENT and French Canadian movies may be www.executiveplanet.com. For head of the Professional subtitled for viewing in France. more in-depth information about Education Training and specifi c countries, I’d suggest the Development SIAC. She currently While it is very important to be series of Global Etiquette Guides serves as a member of the Global aware of and respect diff erent available at Amazon.com. For Forum’s editorial board.

GLOBAL FORUM 19 Manners and More! Importance of cultural sensitivity when medical writers work with authors from the Asia-Paciﬁ c region

Julie A. Ely, Rebecca A. Lew, and Karen L. Woolley

“Eastern and Western management competency model developed by an “Finally…they have something to say styles are 95% the same, international team of expert medical on the protocol…I must have warmed but diff er in every important aspect.” writers.1 Given the increasing clinical them up for you!” Th is simple story trial and publication activity in the reinforces that writers who are Takeo Fujisawa (Co-founder, Honda Asia-Pacifi c region, the demand culturally sensitive are more likely to Motors) for medical writing services in this gain useful feedback from authors in region is likely to increase. We believe the region than writers who are not. “Ru xiang sui su.” that medical writers who provide Off ending your target audience does these services must display cultural not facilitate document preparation. (Chinse proverb: Enter the village, sensitivity if they want to deliver follow the customs) high-quality documents in an ethical, One of the hallmarks of a culturally effi cient, and harmonious manner. sensitive writer is that she or he In this article, we explain why realizes that every country in the Asia- cultural sensitivity is a core Manners - Do they really matter? Pacifi c region is “similar, but diff erent.” competency for medical writers, Amid the many issues writers must Medical writers, particularly those particularly when working with take into account when preparing raised in a Western culture, should be authors from the increasingly documents, do manners really aware of at least some of the principles important Asia-Pacifi c region. We matter? We believe they do. Cultural that are similar among cultures in the provide general and country-specifi c sensitivity can be expressed through region. For example, compared with guidance for writers and use the manners, and a lack of manners the cultures in the West, cultures in example of preparing a manuscript can adversely aff ect document the East generally value: to show how writers should use preparation…as the following story “manners and more” when working illustrates. To help prepare a clinical • Collectivism (more than with authors from the region. trial protocol, two medical writers individualism) attended a face-to-face meeting with Introduction leading neurologists from the Asia- • Respect based on status and age Cultural diff erences can aff ect Pacifi c region. One of the writers, (more than achievements) document preparation. Not who was not culturally sensitive, surprisingly, cultural sensitivity started the meeting by fl icking • Saving face (more than was recognized as a behavioral his business cards at the seated constructive criticism) competency in a medical writer attendees. He asked for comments on the protocol, but received none. A • Modesty (more than pride) No external funding was used for this project. stony silence was evident. Th e other Julie Ely and Karen Woolley are members of writer, who was culturally sensitive, • Self-control (more than the DIA’s Medical Writing Special Interest Area exchanged business cards with the emotional displays) Community (DIA MW SIAC). Karen Woolley was attendees in a respectful manner. a contributor to the medical writer competency She then asked for comments on the • Long-term relationships (more model developed by members of the DIA MW protocol and received many positive, than short-term results) SIAC. All authors are employees of ProScribe Medical Communications and collectively have helpful, and engaging replies. Th e decades of experience in delivering medical fi rst medical writer, still oblivious While these general principles are writing courses and providing medical writing to his cultural faux pas, turned to helpful, medical writers can show

MULTICULTURAL WORK ENVIRONMENT MULTICULTURAL services, particularly in the Asia-Paciﬁ c region. the second writer and whispered, even more respect for authors

20 GLOBAL FORUM by familiarizing themselves with cultural sensitivity. For example, professional medical writers. We country-specifi c considerations at the outset, writers should find it very helpful to provide (Table). As the region comprises a identify the academic position authors with a peer-reviewed mixture of countries (eg, developing and publication experience of publication on the process.4 and developed countries, English as a each author; this will give them Note that a writer may need to fi rst language or English as a second insight into the hierarchy that privately counsel authors about language countries), generalizations may operate within the authorship publication ethics (eg, plagiarism). have their limitations. Even the team. Th e writer’s fi rst contact with Unfortunately, some countries number of clinical trials in each each author is crucial; whether in the region have a high rate country and the temporal trends, that contact occurs via email, of publications retracted for reinforce the diff erences among teleconference, or in person, respect misconduct,5 and the market for countries (Figure). When working for the hierarchy should be shown. ghostwriting is surging; in China with authors from a specifi c country, Communication strategies should be alone, the ghostwriting market writers should, at the very least, culturally appropriate (eg, avoiding increased five-fold from 2007 know how to greet these authors, idiomatic expressions, allowing for to 2009.6 Unlike ghostwriters, when to contact them, and a few periods of silence, speaking calmly, professional medical writers can business “basics” (Table). Writers not loudly). Writers should not be help authors avoid publication working on regulatory documents overly familiar with authors; it takes misconduct4,7 and thus save should know where to source further time to gain their trust and respect. authors from losing face and information on country-specifi c Writers should also be aware of the bringing disrespect to themselves, requirements (Table). need for collective decision making their superiors, institution, and when it comes to identifying the country. Manners and More – How do you key points and data to include in apply manners during document the manuscript. Patience must be Writers should also not assume preparation? shown. that the English language is the Medical writers who help authors greatest challenge for authors from from the Asia-Pacifi c region to Writers should not assume that the region.8 For example, when we prepare manuscripts are given all authors know how to work surveyed Indonesian and Malaysian ample opportunities to display ethically and efficiently with authors (N = 72 respondents; 71% response rate) on publication barriers, 86% identifi ed limited medical writing experience, 82% identifi ed limited writing time, and only 59% identifi ed English-language diffi culties. MULTICULTURAL WORK ENVIRONMENT

Perhaps the greatest challenge for writers working with authors from the region is knowing how to gain and provide feedback. Writers should always be conscious of allowing authors to save face. For example, if an author writes a fi ve-page introduction, the writer should not embarrass the author by criticizing the length of the introduction. Th e writer can help Figure. Clinical trials in the Asia-Pacifi c region from 2000 to 2009. For each the author save face by suggesting Asia-Pacifi c country, the number of newly registered clinical trials with a trial that many of the excellent points site in that country was determined for each year using the NIH ClinicalTrials. the author made would be ideal gov website search engine (accessed 25 May 2010) and expressed as a in the discussion. Privately, the proportion of the total number of newly registered trials in that year. writer may provide the author

GLOBAL FORUM 21 Table. Business “basics” for 14 countries in the Asia-Paciﬁ c region.2,3

Hello Time Population Basic business ICH CTD accepted? Country (phonetic) 9:00 am (millions) “Do’s and Don’ts” Further information Language US EST

Australia 20.26 G’day 11:00 pm • Do give people personal space when Yes speaking to them http://www.tga.gov.au/ (ga-day) EST • Don’t over-exaggerate or boast English • Don’t use aggressive sales techniques

China 1300 Ni hao 9:00 pm • Do exchange business cards and present it Yes (knee how) with both hands http://eng.sfda.gov. Mandarin • Don’t use negative replies, say “maybe” or cn/eng/ “I’ll think about it” • Do address business people with their title and last name

Hong Kong 6.9 Néih hóu 9:00 pm • Do try to always schedule meetings in advance No (nay ho) • Don’t touch business colleagues (ie, back- http://www.psdh.gov. Cantonese patting, arm around their shoulder), as this hk/eps/webpage.jsp is considered rude • Don’t show your anger in public

India 1095 Namaste 6:30 pm • Do address people by their titles or “Mr or Yes (na-mus-thei) Miss” when meeting business colleagues http://cdsco.nic.in/ Hindi • Do wait for a female business colleague to initiate a greeting; Indian men will not generally shake hands with women out of respect • Don’t be aggressive in your negotiations

Indonesia 234 Halo 8:00 pm • Do present business cards printed in English, Yes (ha lo) and ensure all your titles are included http://www.pom. Indonesian • Do arrive on time for meetings, but don’t go.id/e_default.asp expect Indonesians to be on time, as time management is not a priority in Indonesia • Do address people by their titles when meeting business colleagues

Japan 127 Konnichi wa 10:00 pm • Do greet business colleagues with proper Yes (kon nee respect, politeness and gratitude; if they http://www.mhlw. chee wa) bow, you should, too go.jp/english/ Japanese • Don’t address a business colleague by their ﬁ rst name unless invited to do so • Don’t use dramatic hand gestures and unusual facial expressions when speaking • Do avoid confrontation or showing negative emotions

Malaysia 24 Apa khabar 9:00 pm • Do be patient with business colleagues Yes (apa kabar) during negotiations; the process is often http://portal.bpfk. Malay long and detailed and cannot be rushed gov.my/ • Do be polite and acknowledge the eldest (and usually most senior) business colleague fi rst • Don’t assume that a signed contract signifi es fi nal agreement; negotiations frequently continue after a contract is signed MULTICULTURAL WORK ENVIRONMENT MULTICULTURAL

22 GLOBAL FORUM Hello Time Population Basic business ICH CTD accepted? Country (phonetic) 9:00 am (millions) “Do’s and Don’ts” Further information Language US EST

New Zealand 4.2 Hello 1:00 am • Do be on time for appointments; Yes English (next day) punctuality is important in business http://www.medsafe. Kia ora culture in New Zealand govt.nz/ (key or ra) • Do maintain a reserved, formal Maori demeanor in your business dealings • Do not hype, boast, or exaggerate your product or service

Philippines 89.5 Kumusta 9:00 pm • Don’t use direct and continuous Yes (koo-mus-tah) eye contact in business conversations, www.bfad.gov.ph/ Filipino as it is considered rude and default.cfm confrontational • Do engage in small-talk before and after a meeting; establishing personal relationships in business culture is very important • Do dress appropriately when doing business; dressing well and taking pride in your appearance is important in gaining respect and being successful

Singapore 4.5 Hello 9:00 pm • Do read a business card after Yes English you receive one from a business http://www.hsa.gov. Apa khabar colleague; it is considered rude to sg/publish/hsaportal/ (apa kabar) put it away without reading en/home.html Malay the card Ni hao • Do speak in a quiet and reserved tone (knee how) • Do be careful giving gifts, particularly Mandarin to government employees, as this may be considered bribery

South Korea 48.8 Annyong 10:00 pm • Do show modesty and humility in your Yes ha shimnikka business dealing http://eng.kfda.go.kr/ MULTICULTURAL WORK ENVIRONMENT (an yoh • Do give a gift when meeting a business index.php hashim ni colleague for the ﬁ rst time kah) • Don’t talk or laugh loudly in public, as this Korean is considered impolite

Taiwan 23.1 Ni hao 9:00 pm • Do be subtle and avoid excessive Yes (knee how) candor in meetings http://www.doh.gov. Mandarin • Do nod your head or bow tw/EN2006/index_ when meeting; handshakes are EN.aspx generally only for men who are friends • Don’t touch business colleagues; putting your arm on a shoulder, winking, or pointing with your index ﬁ nger are perceived as rude • Don’t interpret a “yes” as meaning “yes,” as it may mean “I understand” or “we’ll try”; Taiwanese will generally not say a direct “no”

GLOBAL FORUM 23 Hello Time Population Basic business ICH CTD accepted? Country (phonetic) 9:00 am (millions) “Do’s and Don’ts” Further information Language US EST

Th ailand 65.1 Men: 8:00 pm • Do exchange business cards; it is Yes sawatdee imperative to give and receive them with http://www.fda.moph. khrab (sa wa the right hand go.th/eng/index.stm dee krab) • Don’t be impatient with business decisions, Women: as decisions require lengthy consultation sawatdee kaa and patience; impatience is seen as a sign (sa wa dee of weakness kah) Th ai • Do use the traditional form of greeting (wai), by bowing your head and placing your hands together, palms facing, ﬁ ngers pointed upward with hands raised

Vietnam 85.3 Chao ong 8:00 pm • Do maintain a soft and quiet voice while Yes (Dzhow ong) conducting business; excessively loud http://www.moh.gov. Vietnamese voices and hand gestures are considered vn/web/guest/home rude • Do give gifts when meeting business colleagues; wrap gifts in colorful paper • Don’t refuse tea or food if oﬀ ered • Don’t stand with your hands on your hips or your arms crossed; don’t use your ﬁ nger to point, use your whole hand

Abbreviations: CTD = Common Technical Document; EST = Eastern Standard Time; ICH = International Conference on Harmonization.

with background information the authors’ institutions, and their Communications, Tokyo, Japan) and on recommended lengths for sponsors. Yuko Kojima (Eli Lilly Japan K.K., manuscript sections. Authors from Kobe, Japan) for reviewing a draft the region also fi nd it very useful Conclusion version of the manuscript. for writers to help them respond to Cultural sensitivity is an important peer reviewers’ comments. Writers competency for medical writers who References can help authors understand work with authors in the Asia-Pacifi c 1. Woolley KL, Clemow D. that “constructive criticism” or region. We have seen how cultural Development and practical even rejection are all part of the diff erences may aff ect document use of an international medical publication process. We have found preparation and how these diff erences writer competency model. DIA it very helpful to provide authors can be embraced and enjoyed by Global Forum 2010;2(3):8-11. with much encouragement and culturally sensitive writers. Medical 2. Communicaid Culture and a peer-reviewed publication on writers who use “manners and more” Communications Consultancy. handling manuscript rejection.9 to establish harmonious and successful Business culture – doing business After a manuscript has been relationships with authors in the Asia- in. Available at: http://www. accepted, the writer should Pacifi c region are, and will continue to communicaid.com/access/pdf/ acknowledge the collective eff ort be, in demand. index.php. Accessed May 24, 2010. of all authors and avoiding singling 3. International business etiquette, out specifi c individuals for praise. Acknowledgments culture, manners, and Geert Helping authors achieve publication No external medical writing assistance Hofstede cultural analysis for global success, in an ethical, effi cient, was used to prepare this article. business students and managers. and harmonious manner, helps Th e authors gratefully acknowledge Available at: http://www.cyborlink.

MULTICULTURAL WORK ENVIRONMENT MULTICULTURAL writers gain respect from authors, Jane McDonald (ProScribe Medical com. Accessed June 8, 2010.

24 GLOBAL FORUM 4. Woolley KL. Goodbye Congress on Peer Review 8. Kojima Y. English isn’t ghostwriters! How to work and Biomedical Publication; necessarily the biggest issue: ethically and eﬃ ciently with September 10-12, 2009; Eﬀ ective ways to help ‘English professional medical writers. Vancouver, Canada. as Second Language’ authors to Chest 2006;130(3):921-923. 6. Qiu J. Publish or perish in China. publish. Paper presented at: 45th 5. Woolley K, Woolley M, Lew R, et Nature 2010;463(7278):142-143. DIA Annual Meeting; June 21- al. Round up the usual suspects? 7. Goetzche PC, Kassirer JP, 25, 2009; San Diego, CA. Involvement of medical writers Woolley KL, et al. What should 9. Woolley KL, Barron JP. Handling and the pharmaceutical industry be done to tackle ghostwriting in manuscript rejection. Insights in retracted publications. Paper the medical literature? PLoS Med from evidence and experience. presented at: 6th International 2009;6(2):e1000023. Chest 2009;135(2):573-577. ■

Julie A. Ely, BA, PhD, is Senior Rebecca A. Lew, BA PhD, is Senior Karen L. Woolley, BHMS Ed (Hons) Medical Writer, ProScribe Medical Medical Writer, ProScribe Medical PhD CMPP, is CEO, ProScribe Medical Communications, Sydney, Australia. Communications, Melbourne, Communications; Associate Professor, You can contact her at je@proscribe. Australia. Contact Rebecca at rl@ University of Queensland and the com.au proscribe.com.au. University of the Sunshine Coast, Noosaville, Australia. Readers can contact her at [email protected]. MULTICULTURAL WORK ENVIRONMENT

GLOBAL FORUM 25 The Intersection of Business and Culture in the Asian Medical Markets

Ames Gross

he US is slowly emerging Chinese physicians and government from a huge recession. Some offi cials. Down the road, these T European countries are relationships can be very helpful trying to repair a broken system. in drug registration and product Trying to conduct business in South launch. America in a “mañana” mentality can be frustrating. As such, drug Diversity of Asia companies need to focus on Asia for As “Asia” is a broad geographical growth. With 2/3 of the world’s term, cultures diff er vastly from population at over 4 billion people, India to Indonesia to Korea. per cent of Th ailand’s population the potential market in Asia is huge. Th ere are many native religions is Chinese, while the rest are Th ai. In fact, Asia was the fi rst region to and philosophies, including However, in countries like Japan and pull itself out of the global recession. Buddhism, Hinduism, Taoism, and Korea, the population tends to be Confucianism. In addition, each very homogenous with very small One large pharma company has a country can have a very diff erent minority populations. well known R&D facility in Shanghai, makeup of religions. For example, another has a $1 billion investment Korea is 25% Christian and 30% in China, and more and more drug Buddhist, while the remaining 45% companies are developing R&D, constitute other religions. On the setting up clinical trials, increasing other hand, China tends to mostly sales and marketing, and building be Taoist and Buddhist. Indonesia is manufacturing facilities in Asia. 89% Muslim and 7% Christian, with Another well known company has the remaining 4% consisting of other also established themselves in India religions. with sales of approximately $159.52 million (November 2009) and over Across generations, there are 2,300 associated personnel. Th ey also diff erences. Globalization also have set up a state-of-the-art has begun to lead a trend away manufacturing facility in India. from collectivism and toward individualism in many Asian Paramount in succeeding in this cultures. Of course, Japan still makes market is fully understanding the most decisions on a consensus basis. Asian cross-cultural issues. Setting up a business that is sustainable for the long term means taking the time Ethnic diversity in Asia also varies and resources to account for local widely. In Malaysia, 30% of the Asian business practices and culture. people are Chinese and 9% are For example, in China, setting up Indian, with the majority of the R&D centers and clinical trials remainder being native Malay. In means building the foundations in China, there are over 50 national

MULTICULTURAL WORK ENVIRONMENT MULTICULTURAL establishing good relationships with minority groups. Fourteen

26 GLOBAL FORUM Successful organizations in Asia Of course, these are general not international players may have oftentimes include executives from stereotypes that are not applicable trouble operating outside of Japan, diff erent cultures that need to work to all. Also, not all Asian countries where other Asian countries still together to be successful. share the same Asian attitudes, do not feel comfortable working for values, and mindsets. However, these Japanese. Another issue to keep in mind is the notions among Asians do exist, and it vast diversity within one country. is important to assuage any possible Similarly, while a truly global For example, China and India cover doubts. By implementing initiatives Indian executive can sometimes such vast geographic territory that demonstrate cultural sensitivity, succeed in East Asia, a local Indian that it does not always make sense you can develop a more cohesive, who is not that global may have to have one overall strategy for cooperative business in Asia. problems getting Japanese and the entire country. Almost every Chinese executives to follow her/his region (in China and India) is very Relationships are the key to doing leadership. diff erent with its own specifi c dialect, successful business in Asia. Senior languages, cultures, and levels of Western executives meeting once In short, hiring the right people to income. Th erefore, understanding or twice a year with their Asia maximize the market opportunities the regional diff erences and also city team does not constitute a close means picking personnel who are diff erences for these larger countries relationship in most Asian countries. not only technically versed in their is also very important. Western executives who see their area but also culturally sensitive. Asian counterparts 6–8 times a Th ey must be adaptable, flexible, and Cultural Sensitivity and Perceptions year (for work and social activity) versatile to adjust plans accordingly Western executives working in are generally more successful. to each Asian country. Th en, Asia must not come across as “ugly Sending out holiday cards yearly Western drug companies must make foreigners.” Th ey must take the with personal handwritten messages, sure to provide enough incentives eff ort to understand that each Asian frequent phone calls, and emails are and retention strategies so that the country is diff erent. For example, all important in forming close ties top employees are interested in a Western Caucasian may not be with your Asian offi ces, affi liates, staying at the company. appropriate as a country manager in or partners. While emails to fellow Japan unless they are truly global and Westerners may start with “Dear Bill: Cross-cultural education is have spent many years in Japan/Asia. attached fi nd these documents…” also important at the Western On the other hand, how could we in Asia, people generally greet each headquarters. Th ere should be expect a Japanese company operating other via email with small talk about educational seminars on the relevant in the US with a Japanese executive the weather, etc., before they get Asian countries for the appropriate who does not know English to be down to business. Other courtesies personnel. Arranging VIP trips successful? include being aware of major to Asia (or vice versa with Asians MULTICULTURAL WORK ENVIRONMENT holidays and sending appropriate coming to the West) can also foster One must also be aware of the greetings, such as the Chinese New stronger relationships and bonds. In corresponding perceptions and Year. addition to executives traveling to stereotypes. Some common and from Asia, it is also a good idea positive perceptions of Westerners Personnel to have your Asian staff work at your from an Asian perspective include With Asia’s rapid growth, there is Western headquarters for a short being confident, energetic, a talent war in fi nding qualifi ed, period of time. Th is way, they can get egalitarian, independent, free, experienced business and regulatory the appropriate technical training and creative. On the other hand, personnel in the pharmaceutical and also feel more connected to the negative Asian perceptions of industry. Make sure to respect company and Western employees on Westerners include legalistic, your employees and highlight the a day-to-day basis. argumentative, know-it-all, opportunities for advancement at culturally ignorant, insincere, and your company. Organizational Structures demanding. There is also an issue Putting the right structure in place with foreign companies being too While a truly global Japanese is key. For example, since a drug US- or European-centric and not executive can sometimes succeed company’s business is oftentimes being really globally minded. in East Asia, local Japanese who are the largest in Japan, most companies

GLOBAL FORUM 27 set up a separate offi ce specifi cally China, Japan, and Korea will require Conclusion for this country. Th en, foreign drug documents in their native language. By recognizing the nuances of companies will usually set up a cultural diversity in each specifi c regional hub for their Asian activities Western executives simply showing Asian country, your company will in Singapore or Hong Kong covering up at an Asian government be guaranteed a higher level of the non-Japan Asian markets. In regulatory offi ce for a key meeting success and long-term sustainability. a general sense, the Japan offi ce generally will not help your cause From developing relationships to should report directly to the Western and may actually hurt you. While sending out yearly holiday cards, headquarters, and not through the practice of lobbying is common international executives and regional the non-Japan offi ce in Singapore in the West, it is less acceptable Asian directors must take the eff ort or Hong Kong. As simple as this in certain Asian countries. When to train themselves and their team concept may be, some foreign drug communication is necessary, let your on Asia cross-cultural issues. Many companies have Japan reporting company’s local Asian staff or local regulatory and business issues stem to Singapore or Hong Kong. Th is Asian distributor’s regulatory staff from a lack of communication, a lack can be humiliating to Japanese deal with the local regulatory body of building strong relationships, and executives, especially if their sales are directly. a misunderstanding of the mentality greater than all the non-Japan Asian and culture present in individual countries combined. In some countries, disclosing all Asian countries. ■ information and setting up pre- Dealing with Regulatory Bodies consultations before a product When dealing with regulatory registration is customary. For a agencies and governments in Asia, meeting in Japan, the MHLW it is important to keep in mind expects the drug company executives that each Asian country will have to wear formal dark suits with a its own specifi c requirements and white shirt and a dark tie. In other procedures. Local Asian offi ces of Asian countries (especially in Western drug companies should be Southeast Asia), the government involved in face-to-face meetings regulatory entity may be a bit more with local regulatory agencies and casual with no tie or jacket needed. Ames Gross is the president and make sure the headquarters knows Th erefore, having personnel who are founder of Pacifi c Bridge Medical. exactly what is happening. In almost knowledgeable on these particulars You can contact him at adgross@ all situations, countries such as is crucial. pacifi cbridgemedical.com.

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28 GLOBAL FORUM Culture and Its Impact on Team Effectiveness

Ira Asherman and Catherine Mercer Bing

Introduction Th is article will look at Hofstede’s of the Medicis. He describes the Recent years have seen dramatic research as it applies to the narrow Medici Effect as, “…a time and growth in the use of project teams, perspective of team eff ectiveness place when different cultures, task forces, and drug development and team leadership. domains and disciplines stream teams in the pharmaceutical together towards a single point… industry. Th is article focuses on the Team Challenges [which allows] for establishing Hofstede research on comparative Team members are located all over concepts to clash and combine, MULTICULTURAL WORK ENVIRONMENT cultures. Dr. Geert Hofstede, author the world and in many instances, ultimately forming a multitude of of Culture in Organizations: Software attend meetings via tele/video new, groundbreaking ideas.”2 of the Mind (the new third edition conferences at all times of the has just been released) and one of the day or night. Groups struggle to However, cultural diff erences, founders of the comparative cultures become high performing teams which are not obvious, also bring fi eld says that “…studying the values in situations where many of the with them a potential downside, that drive people’s behavior helps members have never met, work when team members and leaders decision makers and team leaders at odd hours, and use impersonal fail to appreciate the importance understand the diff erent priorities technology as the sole means of that culture can have on member people attach to their work and their communication. behavior. As one of the authors interactions with others.”1 said in an earlier article, “Working The dramatic growth in global in a multicultural environment is 1 Hofstede, Geert, Hofstede, Gert Jan, and Minkov, teams can become a time of great a distinctly challenging task. Be Michael, Culture And Organization: Software of creative potential. In The Medici it leading a team, talking with a the Mind (3rd Edition), McGraw-Hill, 2010. 2 Johannsson, Frans, Th e Medici Eff ect: What Can Effect, Frans Johansson refers to co-worker from another country, Elephants and Epidemics Teach Us About the time of great creativity in 15th negotiating with a vendor, or Innovation?, p2–Harvard Business School Press, 2006. century Italy, during the reign meeting with the representative of

GLOBAL FORUM 29 a regulatory agency, cultural and Participative Orientation) is defi ned people want more information language diff erences intrude.” 3 as the degree to which inequality or before making a decision and others distance between those in charge feel comfortable making a decision Cultural Diff erences and the less powerful (subordinates) with less information. Hofstede’s research shows that is accepted (by the subordinates). there are measureable cultural Th ink about how Germans and dimensions, each with two distinct Th is dimension aff ects how Koreans (for example) can be orientations. Hofstede’s dimensions people from diff erent cultures “sticklers for details” and want more – Individualism, Power Distance, would describe the qualities and information and more extensive Certainty, Achievement and Time characteristics of an eff ective leader. planning than the people from other Orientation – drive behavior, cultures often think they need. what people do and say. Culture People from participative cultures, is the foundation from which we (even those with a relatively low Th e Achievement Dimension derive our internal values and degree of Participative Orientation, (Achievement Orientation or Quality attitudes. Th ese are learned very such as the US), often have a diffi cult of Life Orientation) is the degree to young and are deeply embedded, so time understanding why anyone which we focus on goal achievement much so, that we rarely even know would not want a more participative and work or quality of life and caring people are diff erent until we fi nd approach. Western practices such for others. ourselves in a situation with others as 360° feedback on teams (give who do not act or speak in the same feedback to your boss? – not a In cultures with higher Quality of Life way we were taught was right, fair, wise career move in Hierarchical country averages (Nordic countries, and “acceptable.” Often at work we cultures) and matrix organizations for example), you will fi nd longer fi nd ourselves thinking, “Well if they (not knowing who is really in charge maternity and paternity leave and would just do this my way, everything – has the most power) are practices 4 – 5 weeks of vacation benefi ts. would be easier.” Hofstede’s from a Western perspective. Th is often causes dissatisfaction on dimensions and their impact are However, these practices can be global teams by the members who feel outlined below. confusing at best or career limiting they are working harder than their at worst in hierarchical cultures. counterparts from these cultures. Th e Individualism Dimension (Individual Orientation or Group In teams, comfort with hierarchy One global Pharma team member was Orientation) is the degree to which (not questioning who is in charge, often heard to complain that team decisions are made for the benefi t of not raising issues to management, members located in the European the individual or for the benefi t of not off ering ideas diff erent from the offi ces “went home on time” even the group. team leader’s) may appear to those when the team members knew that with a Participative Orientation as other team members were on US time Diff erent cultural groups will defi ne lack of commitment to the team, lack and there was very little overlap in the qualities and characteristics of of creativity, or are perceived in other their regular work schedules. an eff ective team member based on negative ways. their cultural orientation. Th ey may Th e Time Dimension (Long- either prefer a more linear work Th e Certainty Dimension (Need term Orientation or Short-term fl ow – I do my work and pass it off for Certainty or Tolerance for Orientation) is the extent to which to you (Individual Orientation), or a Ambiguity Orientation) is defi ned members of a society are prepared to more collaborative eff ort, where we as the extent to which people adapt themselves to reach a desirable work on it together and I help you – prefer rules, regulations, and future, or the extent to which they you help me (Group Orientation). controls, or are more comfortable take their guidance from the past with unstructured, ambiguous, and focus on fulfi lling their present Th e Power Distance Dimension or unpredictable situations. needs and desires. One pretty (Hierarchical Orientation or (Note: Th is dimension is not clear distinction between the two about risk but about planning and orientations is the focus on profi ts 3 Asherman, Ira, Language Culture, and the communication.) One manifestation (Short-term Orientation) vs. market Drug Development Process, DIA Forum 2005; of this diff erence is a very prevalent position (Long-term Orientation). Th e

MULTICULTURAL WORK ENVIRONMENT MULTICULTURAL 41(3):28–30. scenario in teams where some pharmaceutical industry necessarily

30 GLOBAL FORUM has a long-term horizon with a focus Example #1: When Spanish • What are the qualities and on market position. Today’s market members of a research and characteristics of an effective pressures have caused mergers/ Development team cc:d their team member? acquisitions, a concerted eff ort to functional boss on all team fi nd new indications for existing correspondence, Americans viewed • What are the barriers to compounds, and a focus on rapid this behavior with skepticism. building and maintaining trust decision making/being fi rst to market. When asked, they thought it might on a team? mean that they were not trusted. Each of these Hofstede dimensions The Spanish members of the team Th is simple list of answers (which rarely exists in isolation from other thought the Americans were trying WILL diff er) will uncover many areas dimensions and each is much more to hide something when they did where establishing protocols will complex than explained in this broad not cc: their own supervisors. provide clarifi cation and help to resolve overview. diff erences in culture and language. Example #2: A lack of trust was born Pressures on Global Teams and when the American repeatedly emailed Decision Making: Whether Global Team Leaders a specifi c request to his European decisions are made at the top, with Team leaders need to be cognizant of colleague. Th e requests got more or without robust conversation and how to mitigate the negative impact and more demanding over the week. input, or are made by consensus language and culture might have on Th e European colleagues became (everyone must agree before the meetings, decision making, handling frustrated that if this was so important, decision is to be made) – all are of confl ict, dealing with time zone why didn’t the American pick up the underpinned by various cultural diff erences and language diff erences. phone and talk to him directly? preferences. For those with a Hierarchical Orientation – decisions Meetings: Besides the more obvious Example #3: When the US need to be made at the top. In issues about who sits where, Director asked for the fi nal report some cultures, there is little or no especially important in hierarchical to be submitted ASAP, the Asian discussion or involvement of team countries, other nuances impact Analyst felt she could get around members in the decision making. team eff ectiveness. In some Asian to submitting the fi nal report when For those with a more Participative cultures, meetings are seen as her other work was complete. Orientation, this feels demeaning, ceremonies/ceremonial. Th ey are (Th e literal translation of as soon as if their opinion is worthless. If a NOT where decisions are made or as possible does not carry the team leader involves team members problems are discussed. All that same meaning as the Western in conversation when it is their happens BEFORE the meeting and understanding of it.) expectation that an eff ective team the meeting itself is the time for the leader makes decisions without input announcement of the decision. Example #4: An IT and QA team from the team, the team members MULTICULTURAL WORK ENVIRONMENT member became discouraged and may view the leader as ineff ective People who have more of an thought he was about to be fi red. and unable to make decisions. orientation towards the culturally Th e invitation to an important team defi ned Need for Certainty fi nd meeting was distributed to everyone In some cultures, issues are discussed meetings without agendas frustrating but him because the team had never behind the scenes (not in meetings) and disorganized. Th ey may feel fi nalized a team distribution list. and people are involved, invited to that meetings are too loosely run or have their say (sometimes in social accomplish too little because all that Global Team Leaders can avoid settings such as drinks after work, happens is idea generation and more many of these misunderstandings by rather than at work, for example in ideas are thrown out for discussion collecting information as the team Japan). Team leaders who misinterpret but decisions are not made. begins to form – either in a survey these options for culturally appropriate prior to the fi rst meeting or in the approaches or ignore them, may do so Although it sounds obvious, clearly fi rst meeting – about the following: at their project’s peril. establishing team protocols goes a long way to minimizing typical • What are the qualities and Confl ict: When things do not go misunderstandings. Here are a few characteristics of an effective well, team interactions break down real-life examples. team leader? very fast on virtual and global

GLOBAL FORUM 31 teams. Repair of the damage also is tiring to work in a “second language.” culture values is both more important particularly diffi cult at a distance. Native speakers often know many to understand and less obvious to Leaders need to be particularly more defi nitions for each word identify as a team pressure. sensitive to cultural attitudes about than second language speakers, confl ict (which diff er greatly) in order which means nuances are lost. In Just because people do things or view to avoid having misunderstandings critical situations, such as scientifi c things diff erently (whether this is based blow out of proportion. Some cultures research, clinical trials, and regulatory on culture or personality) does not mean believe in maintaining harmony or not compliance, these nuances are even they are wrong. Diff erent perspectives raising critical issues for consideration more important. In addition, people can signifi cantly enhance creative because others on the team (or consistently report that they are far thinking and problem solving. Try to the team leader) disagree(s). Some more creative and think much faster think, “It is not wrong; it is just diff erent.” cultures prefer “heated interactions” in their primary language. Th e issue of and the intellectual challenge of language is of particular importance Th e steps to build cultural sensitivity, robust discussions. Th is approach to pharmaceutical teams as English are to fi rst, recognize that cultural may make team members from group is the language of this industry; diff erences are real; second, respect cultures, who value harmony, very however, not everyone is suffi ciently that others are diff erent and will not uncomfortable. fl uent in English. To make sure they change just because it is convenient are easily understood, sensitive team for you if they do; and lastly fi nd ways Time Zone Diff erences: Most global members avoid the use of acronyms to reconcile the diff erences. Hofstede teams are also virtual. Th e more widely and sports analogies which are hard calls this reconciliation of diff erences dispersed the team members, the to understand (cultural context) or – the establishment of practices. greater the potential for stresses on the just do not translate well. Use practices or protocols that take team. Too often people are working into account the needs of the various virtually (which in relationship cultures Because one can speak a second cultural orientations on the teams. is more diffi cult than face-to-face) language does not mean they are when they are most tired (during the equally facile in writing or reading it Recommendations for Creating evening or late night hours), in a second (or they may be better at reading or Eff ective Global Teams language. It is precisely this time writing than speaking). One global If you are the team leader there are when they are at their least eff ective team success strategy is to make a number of things you can do to as thinkers and communicators. An sure everyone has equal access to ensure that culture and language do unintended consequence to these information in the mode in which not have a negative impact on your late night meetings for those not at they feel most accomplished. Th is team’s performance. Among them are: headquarters, is the feeling that those means using agendas and sending required to be available for meetings them in advance of the meeting, • Create opportunities for team at odd hours are somehow less valued carefully communicating at the members to get to know more members of the team (which could lead meeting and following-up with about each other (Group to morale issues). written summaries of action items Orientation) not just about their and decisions made. Another success work experience and capabilities Eff ective global teams stagger the strategy is for team leaders to allow (Individual Orientation). start time of team meetings so that those in natural language groups all members are equally “put out” to converse in their mother tongue • Find out from team members over the course of the project. Th is after the meeting to allow them what they think the qualities often minimizes the unintended to discuss and come to agreement and characteristics are of an consequences and recognizes those on their understanding. If team “eff ective leader” and “eff ective working in second languages need leaders stay during this check/ team member” (Power distance to be at their freshest when they are re-check conversation, they are preferences). Ask team members working on diffi cult challenges. available to answer questions or off er what creates barriers to eff ective clarifi cations needed. team work. Understand that Language diff erences: Anyone cultural diff erences will give rise who has studied a language other While language and time zone to very diff erent answers. Th ese than their “mother tongue” will tell diff erences are obvious stressors for. should be acknowledged and

MULTICULTURAL WORK ENVIRONMENT MULTICULTURAL you that it is especially diﬃ cult and those on global teams, the impact of discussed.

32 GLOBAL FORUM • Set team protocols for diff erences that might negatively human process interactions on communications (Need for impact team performance. teams are not going well, this is a Certainty), leadership, meetings, leading indicator that the team is decision making (Power • Give members who do not not likely to meet its goals (on time Distance), and handling confl ict speak English as a first or on budget). Also, the speed with (Group orientation) that refl ect language more time to respond which products get to market may the team’s cultural and language to the discussion. Accept be a direct function of how well diversity. written ideas after the meeting the issues of cultural and language even from groups (Group differences are addressed. • Manage individual and group orientation). performance in accordance with cultural preferences (Power • Speak distinctly and avoid the use Distance and Individualism of sports analogies, jargon and the Dimensions). telling of jokes.

• Track the human interactions on • Paraphrase and summarize more team members (for example with frequently (Need for Certainty). team questionnaires) so that you can identify potential cultural and See Exhibit 1 for a summary of this process issues before they become check list. serious problems. Conclusion • Acknowledge the fact that not Leading and managing a team IraIAh Asherman is i a consultant who meeting face-to-face might have under any conditions can be specializes in the issues faced by a negative impact on meeting difficult. Add the unique dimension negotiators in the drug discovery eﬀ ectiveness (Achievement and of culture and language and the and drug development areas of Group orientations). leadership responsibility becomes the pharmaceutical industry. Ira far more complicated. To be done can be reached via email at ira@ • Take the time to learn something well, it requires a great deal of asherman.com. His website is www. about the diﬀ erent cultures sensitivity and awareness, not only asherman.com. represented on your team. Find a by the leader but by all of the team culture mentor. members to the issues faced by co-workers from other countries • Be vigilant about watching for and cultures who may not speak any the cultural and language English as a first language. If the

Exhibit 1 MULTICULTURAL WORK ENVIRONMENT

CatherineCthi (Cass) (C )M Mercer Bing, is CEO of ITAP International, Inc. ITAP is one of only three consulting and training companies endorsed by Dr. Hofstede and approved to represent his research. ITAP can be reached via email at cass@ itapintl.com or found at www. itapintl.com.

References. Additional books and articles can be obtained from either author’s websites. ■

GLOBAL FORUM 33 Inna Kassatkina, Stacy Liechti and Mark Opler

he globalization of clinical Trials continue to shift to emerging relationship and the meaning of trials no longer is a matter of markets, such as China, Russia, and consent/assent may vary. T speculation; it is a fact. Th e India, in the search for more patients, question that industry professionals, lower costs, and faster recruitment. • Intercultural communication scientists, and regulators now must Moreover, many of these countries and language barriers as they contend with is not whether have centralized health systems; relate to the trial - doctors/ globalization will continue, but meaning that hundreds of patients patients/vendors may respond rather how it will aff ect both the art with similar symptoms are found in diff erently to varying levels and science of clinical research and the same place, with larger numbers of of formality, have diff erent the world at large. both study-naïve and treatment-naïve priorities, concerns, etc. subjects as compared to other regions. Each stage of a drug’s life cycle is Conducting Clinical Trials in Russia touched by language, culture, and For drug development companies to Russia and Russian-speaking national infrastructure needs. In this continue to research novel compounds populations fi gure prominently in article, we will discuss briefl y culture and and to reach new patient populations, clinical and research studies. language, key aspects of clinical research and to do so in a responsible and that have gained new prominence in the constructive manner, it is critical to Th ere are diff erences in the ways that context of multi-national trials, and their understand the unique role that culture Russian clinicians conceptualize disease impact on global trials. plays, and how to use this understanding when compared to other countries to foster meaningful communication - which may stem from training, The Shift Eastward with patients, physicians, project teams, professional experience, and other Pharmaceutical companies increasingly and other stakeholders. cultural factors.2 In a study by Rezvyy, et are shifting clinical trials to emerging al, Russian clinicians were found to use a markets - as much as 40 percent of Th e best way to appreciate the issues wider range of diagnoses for psychiatric all drug trials in 2005, up from about inherent to global trials is to consider disorders and emphasized diff erent 10 percent in 1999.1 According the diff erent aspects of trial conduct aspects in their decisions as compared to to the research fi rm Euromed and what these basic concepts mean Norwegian clinicians.3 To date no careful Communications, Central and Eastern in another context (eg, another analysis has been conducted to assess the Europe (CEE), for example, plays a country, region, culture). For example: impact of factors such as experience and vital role in global clinical research culture at the item-level for Russia. and development. With 350 million • Good clinical practice topics, inhabitants, the CEE has become a large such as true and informed Trials now are conducted in the

MULTICULTURAL WORK ENVIRONMENT MULTICULTURAL source of patients for commercial trials. consent; the physician/patient greater expanse of the country which

34 GLOBAL FORUM has increased the diversity of patient immensely diverse and heavily populated Regulations and Guidelines Pertaining populations within Russian trials. country-a potential challenge for to Language Translation Issues Even in the major cities (Moscow, St. recruitment. Many sponsors new to Regulations may prohibit or limit what Petersburg) where trials commonly work in India bring with them the one can say about a drug, its availability, are conducted, large populations assumption that since English is the or competing compounds. In the from the former Russian republics, primary language of medical training and United States, the Food and Drug both of Russian and non-Russian education, it should frequently suffi ce as Administration (FDA) has language backgrounds, may be present. the “offi cial” language for the trial. And, requirements for documentation while consent forms and other materials and fi ling. Also in the US, there are Conducting trials in Russia, as with any at the screening level are translated national standards on Culturally and setting, presents trials designers and into one of the many local languages, Linguistically Appropriate Services implementers with additional challenges. once the patient has been enrolled and (CLAS), developed by the Offi ce For example, Russia has its own randomized, the availability of non- of Minority Health, US Health and distinct medical tradition and system of English materials in terms of case-report Human Services, as well as mandated education. Th ese distinctions impact the forms (CRFs), clinician administered protection for patients with Limited conceptualization of disease pathology, measures, or even patient-reported English Profi ciency (LEP).5 diagnosis, and perception symptom outcomes (PROs), may dwindle. severity or relevance. To complicate From a global trials perspective, matters further, the source of variance in While clinician English fl uency is good clinical practice (GCP) is an areas such as those listed above may not exceptionally high in India, patients international ethical and scientifi c be transparent. Is the variance caused may be unable to participate fully in the quality standard for designing, by a diff erent cultural understanding or program without full linguistic support recording, and reporting trials that interpretation of patient presentation and forward planning. However, involve the participation of human or is it a matter of proper translation or language alone cannot resolve all of subjects. Compliance with this communication, a clinician’s experience, the issues encountered during clinical standard provides public assurance or a complex hybrid of all of these? trials in India. As with many world that the rights, safety, and well-being populations, certain topics may be of trial subjects are protected and While most research training for clinical socially and culturally inappropriate that the clinical trial data are credible. trials is still conducted monolingually for direct questioning techniques (in English), even full translations of and investigation. Investigators in Free and informed consent lies at the documents and simultaneous and a trial may be reluctant to broach heart of ethical research involving synchronous translations during particular topics with their patients human subjects. It encompasses a meetings may still prove to be and patients may be unlikely to answer process that begins with the initial insuffi cient if cultural factors are not such questions. It is incumbent on contact and carries through to the end considered. For example, in an analysis of those designing trials, administering of the involvement of research subjects MULTICULTURAL WORK ENVIRONMENT training data from a CNS trial in Russia, training, and providing linguistic and in the project. Failure to properly obtain when controlling for language and cultural support to consider potential informed consent is one of the most experience, cultural factors continued problem areas prior to executing a commonly cited violations at research to play a role in the interpretation and trial and plan for contingencies and sites. Seven of eight warning letters from evaluation of symptoms. Knowing areas modifi cations. Negligence in this area the FDA sent to clinical investigators where local or cultural factors play a may lead to defi cient and unreliable between May and September 2009 role will help to guide the design and data as well as uncomfortable trial specifi cally mention failure to properly implementation of start-up training and patient participants. Conducting obtain informed consent, most often as programs. Clinicians who had little or no trails in countries such as India raises a result of having participants sign an experience using research metrics but additional complications which trials outdated version of consenting forms.6 who have extensive clinical experience designers must consider in depth. For Some problems inadvertently arise also seemed to benefi t from culture- example, diff erent relationships and when translating consent documents specifi c training methodologies. rationales for taking medications and into a new language. Content can either seeking medical services may create a get omitted or be translated incorrectly. Patient Recruitment in India perception of noncompliance, a term During translation, many terms become Another country of central importance that fails to capture or address the local diffi cult to understand even for health to global trials is India. India is an reasons for discontinuation.4 care professionals.

GLOBAL FORUM 35 Among diff erent documents given to Further, cultural values diff er from multistep process that typically a research subject, informed consent country to country, as well as from includes dual forward translations documents may be some of the most community to community. For of the instruments followed by their important. Th eir wording is carefully example, in some cultures it is reconciliation into a single forward monitored by research ethics boards important that researchers talk about translation. Th e next step consists (REBs) in accordance with GCP the trial with, and possibly obtain of a back translation, which is then principles. According to GCP, the permission from, the patient’s family compared to the original source language used in the oral and written and local community before attempting text. Based on the back translation information about the trial, including to obtain consent for participation in fi ndings, mistakes or ambiguities the written informed consent form, a clinical trial. According to fi ndings are corrected in the single forward should be as nontechnical as practical from a study published in the Journal translation. For some languages, the and should be understandable to for Medical Ethics on community- translation is then adapted into local the subject or the subject’s legally based trials and informed consent in language dialects. acceptable representative and the rural North India,7 the majority of the impartial witness, where applicable. community interviewed could decide With so many linguistic diff erences about participation only after discussing and cultural nuances – even within To help ensure a patient’s it with other community members. the same country – it is crucial understanding of the trial and realize Only a third of all respondents could to validate trial documents for free and informed consent, the take an exclusively independent, accuracy. A method used to confi rm translated version of the informed non-consultative decision. In the case consistency is linguistic validation of consent documents should preserve of the few women interviewed, this the translated questionnaires through the original content and style. Th is number was even lower. Most believed pilot testing on real people, also called includes everything from font size they would be unable to decide for cognitive debriefi ng. For each target and footer information to descriptive, themselves. language, an in-country focus group nonmedical terms, if that’s what is organized; run by a professional was used in the source document. A look at PROs bilingual moderator using a structured And, precise translation equivalents Patient-reported outcome interview approach. Each focus group must be used for key terminology to (PRO) instruments are the only consists of people – native speakers avoid critical mistakes. For example: measurement tools that report what of the target language - across “replacement dose” is not the same the patients experience as it relates to diverse economic, education, and as “additional dose” and “study” or their treatment, symptoms, or quality demographics to make up a general “research” does not equal “treatment.” of life without it being interpreted by population for the testing, the results Specifi cally, as it relates to Indian the physician. For an instrument to of which are reviewed by the language languages, the terms “symptoms” be used in multicountry studies, it experts and in-country research and “signs” are often translated using must address the same concepts in all teams, and implemented into the the same word, while more accurate languages to make it possible to pool fi nal version of the translated PRO words are available. “Infl ammation” data and compare results. Th is is done instruments. Benefi ts of conducting and “infection” are also commonly through a series of steps involving focus groups include the ability to mistranslated words. multiple teams of translators, editors, uncover areas of cognitive diffi culties, and in-country clinical researchers, grammatical and translation mistakes, But, sometimes the names of diseases as well as cognitive debriefi ng groups and cultural irrelevancies. or other medical terms should remain to ensure accuracy across languages, in English despite their translations dialects, and cultures. However, once Managing the Translation Process being available in the local language. the English version is translated into To comply with the law, organizations Th is would occur if the term is not another language, the possibility of must keep the information they publish readily used, or if more people are inconsistencies arises, particularly up to date and consistent across all aware of the English term than the when there are a number of diff erent of their packaging, websites, and Indian language term. Th e linguist languages spoken throughout the trial marketing materials. Consistency across must use judgment to maintain a sites and trial countries. documents and channels is hard enough balance between the need to explain in just one language, but it gets more and popularize new medical terms vs. Translation and linguistic validation complicated as you add the process of

MULTICULTURAL WORK ENVIRONMENT MULTICULTURAL understandability of the translation. of PROs must follow a rigorous, translating into other languages.

36 GLOBAL FORUM To reach non-English speakers, project outcome, as well as to anticipate pharmaceutical companies typically how confi dentiality, LEP, and other legal outsource to language specialists regulations may aff ect the trial. in the medical translation industry. Depending on the volume of languages It is also advisable to obtain guidance and documents to translate, this can from local experts and organizations sometimes result in working with with area-specifi c knowledge regarding multiple vendors. To ease and expedite disease concepts, cultural, and linguistic these projects, it often helps to centralize issues. Careful forward planning can be the translation process. One aspect essential to success, particularly in key of this centralized approach involves activities such as start up training and working with as few translation vendors when dealing with certain specialized as possible. Another key aspect is to areas of medicine such as psychiatry, Inna Kassatkina is co-founder rely on technology, eg, manage content neurology, sleep medicine and pain and president of Global Language across multiple languages, locations treatments in a global study.8 Solutions (www.globallanguages.com). and translation providers via content management systems and translation References memory (TM) tools. Finally, by 1. Lustgarten, Abraham, “Drug Testing Goes centralizing translation management via Off shore,” FORTUNE Magazine, August one department, a core contact team, 2005. or even a designated project manager, 2. Lavretsy, H. (1998). Th e Russian concept organizations can streamline their of schizophrenia: a review of the literature. translation procurement eff orts in a Schizophr Bull, 24(4): 537–557. more eff ective, and, often less expensive, 3. Rezvyy, G, et al. (2005). A comparative manner. Th is will help organizations study of diagnostic practice in psychiatry manage multiple languages and in Northern Norway and Northwest numerous translation vendors or vendor Russia. Social Psychiatry and Psychiatric locations, resulting in faster turnaround Epidemiology, 40, pp. 316–323. times and fewer translation errors. 4. For more extensive information on this subject, we recommend referring to Veena Stacy Liechti, PhD, is Director of Concluding Thoughts Das and Ranendra K. Das. “Pharmaceuticals Research & Training Development at In today’s increasingly global clinical in Urban Ecologies: Th e Register of the ProPhase LLC (www.prophase.com). trial environment, incorporating Local.” Global Pharmaceuticals: Ethics, language and culture into the drug Markets, Practices. Eds. Adriana Petryna, MULTICULTURAL WORK ENVIRONMENT development process plays an Andrew Lakoff , Arthur Kleinman. Durham, important role in meeting product NC: Duke University Press, 2007. demands. Communication problems, pp. 171–205. proper drug usage, and issues of true 5. www.lep.gov and informed consent can occur in any 6. Borfitz, Deb, “Informed Consent Errors and every setting and are potentially a Global Phenomenon,” eCliniqua, compounded in multinational trials. January 2010. 7. DeCosta, D’Souza, Krishnan, Chhabra, Planning should include expense Shihaam, and Goswami, “Community based and time estimates for translating trials and informed consent in rural north documentation to and from local India,” Journal of Medical Ethics, 2004. Mark Opler, PhD, MPH, is President languages, especially for clinical trial 8. Eff ect of Language-specifi c Training on of ProPhase, LLC, Executive forms and documents, and factor in Rater Performance in Assessment of PANSS Director of the PANSS Institute, costs and time for developing language Items and Subscales (ISCTM February Assistant Professor of Psychiatry & strategies. Develop a communication 2010 & NCDEU 2010) Stacy Liechti, PhD Environmental Medicine at NYU, strategy that outlines what methods will Evgenia Ivanova, MA,MS Sofi ja Jovic, PhD and Adjunct Assistant Professor of be used to address the language and Jessica Gordon, MA Mark Opler, MPH, PhD Psychiatry at Columbia University cultural factors most important to the Christian Yavorsky, PhD. ■ (www.prophase.com).

GLOBAL FORUM 37 R. L. Chamberlain

have found that working in a Since the Russians left, the residents Th e European culture, particularly multicultural environment off ers have worked hard to restore much the Northern European culture, is I many challenges and of the city. It is a walled city on a not really all that diff erent from the opportunities but probably not hill and is across the Baltic Sea from American culture. Recent eff orts to where you expect, particularly in the Helsinki, Finland. Th e way to get harmonize FDA regulations with pharmaceutical and medical device there was to fl y to Helsinki and then those of the European Community industries. get a helicopter the last 80 miles to have made the work in Europe Talin. virtually the same as in America. I was fortunate enough to be able to manage a very large clinical trial in I had just bought a new digital Th ere are some diff erences though, Northern Europe that was sponsored camera and was taking pictures that impact clinical trials and by a large US pharmaceutical one afternoon. At one point I other work. For example, the company. I was in Europe so much it was standing at the main gate Scandinavians just don’t get it when was cheaper to rent a house for me in looking into the city and could it comes to vacations. When the fi rst London than it was to pay for a hotel see down three of the streets. I of July comes, they are gone for six room. Basically, I lived in London for took pictures looking down each weeks. Th eir parents all own homes nine years. of the streets. When I got back to on the shore of the Baltic Sea. During my hotel I reviewed the pictures the summer the sun shines about Th e people I worked with were on my laptop, and noticed on the 20 hours a day. Of course, during English, New Zealand, Irish, picture of the main street going the winter it only shines about four Australian, Scottish, Danish, straight through the gates that hours a day but they don’t take Swedish, Finish, Norwegian, and a small sign about a foot square vacations then – they can’t; they are American. was sticking out from the wall snowed in. about two blocks into the city. Perhaps the culture that I thought Out of curiosity I enlarged the Th ey spend six weeks living with would be the most diff erent was in picture to see if I could see what their families, boating, fi shing, and Talin, Estonia where I attended an it said. Guess what – It had the just relaxing. Th is means that if investigators’ meeting. Estonia used MacDonald’s Golden Arches on it. you need something done on your

MULTICULTURAL WORK ENVIRONMENT MULTICULTURAL to be part of the old Soviet Union. I was home! clinical trial – forget it. Th ere is

38 GLOBAL FORUM only an answering machine at the Now in a culture that provides matter how bad things are, no matter offi ce. Scotch and Sticky Toff ee Pudding to what is going on in the world around the world, they are certainly doing them, the Irish know how to have fun Now this can’t be healthy. How their part to further research into and enjoy themselves. can the human body sustain such a cardiovascular diseases – both the change in physical and emotional cure and the cause. Th at leaves the Brits. Now our activity for such a long period of culture is not all that diff erent from time? It reminds me a little of the Another culture I was able to work the British culture because our some of the cultural diff erences with during my tenure was the country was settled by a lot of Brits. we have in America. It is well Irish. It started with helping a new Over the years of course, there are known that in and on the edge of clinical lab in Dublin get set up with some diff erences. I am not sure they the Appalachian Mountains in our validated computer systems and impact clinical research but perhaps Eastern United States there is a the necessary training, procedures, they could. For example, one year I subculture. Th ese comprise rural, supplies, etc. was attending the Queens’ Birthday hard working, laborers who live a celebration on the Mall in London. simpler life and view life in a more While working on setting up the Th e Mall runs between Buckingham direct fashion. In central Virginia, at lab, one night we went to the Palace and Trafalgar Square. On one the base of the Shenandoah Valley, Temple District in Dublin, which is side of it is Green Park. As I walked the deer hunting season starts on where a lot of the restaurants and over to the Mall I noticed, in the November 1. Th ese individuals will bars are located. Th is particular middle of Green Park they had set quit their jobs and get a couple of night we went to a place called up 20 port-a-potties arranged in deer to put in their freezer to live Dougherty’s. Th e building had three two rows of ten each back-to-back. off of until spring when they go out fl oors. We would call them fi rst, Approaching the area, I noticed that and get their old job back, or one second, and third fl oor, but the on one side they were lined up 10 to like it, until the next November. If culture in Ireland refers to them 12 deep but on the other side there you have any construction work as the ground, fi rst, and second was no more than two in any line. that needs to be done, you better fl oors. Th e restaurant was on the Standing there looking at this to see get it fi nished before the fi rst of third (second) fl oor. It was very if I could fi gure out the reason, a November. good – all traditional Irish dishes. man passing by stopped and asked Th e fi rst (ground) fl oor was a bar. me if I needed something. I pointed One interesting bit of history is that It looked like a New York wine bar. out my puzzlement to him and he the original settlers in this part of However, on the second (fi rst) fl oor said “Oh, that’s the way Brits are.” If America were from Scotland. Now was a large rectangular room that they see a line forming they will get are the Scottish like that? I don’t had a bar across one end; there were in it.” It’s their own law of lines. think so. only a few tables and chairs – most MULTICULTURAL WORK ENVIRONMENT of the people were standing. Th ere I suppose we could use this for Certainly no one in Appalachia is were shelves around the walls of enrollment in clinical trials. We making Scotch. Th e Scottish do the room for you to set drinks. At could hire some people to form a line make things other than Scotch. For the end of the room opposite the and then others would join. example, almost every menu in a bar was a stage that was about eight British restaurant will have a dessert inches high. It probably measured Th e other thing I found out about on it called “Sticky Toff ee Pudding.” about ten feet by eight feet and on the Brits has to do with living in Now, after doing some research, it it was a picnic table. At the picnic rural England. Most of the people in appears that this dessert actually table sat six musicians. Th ey played rural England do not live in castles or came from Scotland. If you haven’t and sang traditional Irish folk manors. Th ey live in small cottages had it I would suggest you try it, but songs. Some people sang along and that are several hundred years old don’t eat it too often or you will wind a few even danced. Dougherty’s was and cannot be changed or added to. up in one of the blood pressure/ the place where the Irish go to enjoy When they want to entertain friends, cholesterol studies. It is made with themselves. they do not ask “when will we invite things from your four basic food them over” instead it is “when will groups – eggs, cream, sugar, and I have to say one thing about the we meet them at the pub and at butter. Irish culture (I am 25% Irish). No which pub shall we meet.” Th e rural

GLOBAL FORUM 39 pubs are an extension of their dining exposed. Th e interesting cultural health, their own jobs, and all the rooms and living rooms. Th e pubs thing about the pub was that it was other things we all worry about. ■ are not a place where people go to fi rst opened in 1492. It had been on eat and drink by themselves. It is a the intersection for 500 years. It can place to meet their friends. be a challenge for us in our culture to comprehend that. Th e fi rst time I went to England, I went to York, which is on the Although there are some diff erences East coast of England. One night in clinical research, mostly it seems everyone in our party was taken to a to be very similar. Otherwise, I did country pub outside of York. It was not see a lot of important cultural on an intersection in the country diff erences. In the end, everyone I with only farms on the other three worked with worked hard. Th ey were corners. When you enter the pub smart, friendly, committed, wanted you go down three or four steps, to do the right thing and do it right. Dick Chamberlain is founder of so you bend over to go in and then Executive Consultant Services, Inc you stand up straight after you get I found that when they went home and can be contacted at RLChambe@ in. Some of the beams and timbers at night, they worried about their aol.com. Dick is a member of the in the ceiling and walls were still children’s education, their parent’s Global Forum’s editorial board.

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40 GLOBAL FORUM REGULATORY UPDATES 41

ective GLOBAL FORUM GLOBAL ected over ected airs, Operations, airs, on rely must companies erefore, for the countries in which they countries the for manage products, expectations the regulatoryof the authorities within product their and how country, that developmentmarketing and bestrategies aff may required e knowledge and time. Th understanding is vast, which makes it challenging become to a global expert in pharmaceutical development. Th in regulatorygathered intelligence, local their addition to experts, to provide knowledge and guidance regulatoryabout the requirements and expectations regions within the products their where marketed. are All be must information compiledof this and analyzed build an eff to regulatory 1). strategy (see Figure Everyone who has worked in Regulatory Aff the knows that or Compliance us, ective regulatory ective that is a plethora of information ere Regulatory authorities are attempting Regulatory attempting authorities are streamline and standardizeto their submission structures through and emerging formats existing such as ASEAN, eCTD, CTD, and is standardization provides Th STED. an opportunity organizations for submission streamline their to planning and production activities. without proper analysis However, strategies,and implementation the end up beingorganization less may higher risk and at than cient effi change. Th prior adopting the to needthe eff for life in the management information sciences industry has become even criticalmore ever. than Th bemust managed and understood scienceswithin a life organization. Regulatory must professionals regulatoryunderstand the landscape uences e almost e e costs associated ect not only the nes from regulatory

constantly challenged bring to constantly new products and improved ife sciencesife organizations are

cant ﬁ cant Figure 1. RegulatoryFigure Strategy Inﬂ

Sarah PowellSarah L instantaneous information available available instantaneous information must globally companies means that impact in every the consider country in which a product is marketed and aff its to ability to market faster with fewer resources. realizingCompanies are strategic the importance of emerging markets in activities product-planning their as increased as for potential well the risk as information to global access Th explode. to continues product itself, overall but alsothe corporate image. Th with noncompliance with the with the with noncompliance can result in application approved signifi authorities, value in market a drop as revenues from product sales fall, and will public possibility the the lose that supplier. in the dence confi 42 REGULATORY UPDATES

GLOBAL FORUM of questions within each segment: each within of questions maysclerosis the types following ask for the treatmentproduct ofmultiple example, acompany anew developing For anorganization. within processed information iscontinually and gained fl intentionally inacircular represented Th Figure 2). (see andapplied evaluated, must continually consumed, be Th evolving. of the are regulations) continually (andinterpretationsregulations Strategy Objectives Evaluate andDefi ne Product • • • • Figure 2. Regulatory Information Flow Figure 2.Regulatory ow because this how represents ow because e activities inFigure 2are eactivities product be registered? be product the In whichcountries will andwhere?conducted How must manybe trials clinical the indication? What isthe available market for or both? chronic-progressive, remitting, for –relapsing- my product What isthe indication target erefore, information • • • • Manage SubmissionPlan Prepare CommunicationPlanand • • • • • registration effregistration region? ineach ort the eff development for managing Who isresponsible infi registered be product the will Which country(ies) accelerated approval? or designation for orphan Are there opportunities the identifi in forrequirements registration What are the regulatory and does itexist? and does What information isrequired based? where are they and What resourcesare required used? What be submissionformat will submission? When isthe target date for needed? is What submissiontype ed ed countries? ort? ort? Th rst? e Output Produce andShareSubmission • • • • • • • • • Manage Submission Communicate Regulatory Actions and • • • • • • the submission andwhen? notifi to be Who needs previously? submitted this informationHas been the information? for providing Who isresponsible When isthe information needed? come from? theWhere information will submission? What isthe status ofthe orchanges? submission milestones notifi tobe Who needs and/orapproval? review for themilestones submission What are the expected received? the submission When was authority? todelivered regulatory theHow submissionbe will and/orcountry? region each with shared theHow submissionbe will requirements? compliant regional with Is the submissionoutput electronically? or inpaper submitted Is the submissionbeing by the appropriate people? andapproved internally reviewed be information alltherequired Has included? information Is allthe required ed ed regarding ed ed about REGULATORY UPDATES 43

cation GLOBAL FORUM GLOBAL ey global access have Th regulatory to intelligence including notifi information changingon the regulations, have regulations current and to access guidance, and canavailable utilize regionaltheir experts during the documentation and preparation processes;approval and globally accessible, ey have Th integrated systems for are the most the successful in ensuringare product plans for their success that alignedare with market reality. of a planning andAn example process submission for communication is shownplanning and communication 3 below. in Figure successful in are Organizations that managing regulatory the information have compliance and maintaining factors:two common 1. 2. ned ective communication ective What product formulation can product What formulation be shipped or investigator an to country? Who needs provide follow- to up on commitments, other or follow-up actions? is information Which labeling most set?the approved current ation Process ese questions are asked repeatedly processes, fully utilize experts, their eff and have Keys to Success Keys defi have Organizations that • • • Th as new is received information and processed organization, by the product adjusting the thereby development and/or submission of on any plan. A miscommunication these quickly result in topics could with an situation a noncompliance organization. ed? anning and Communic ort? Where can productWhere the be shipped? the registrationthe eff What is the approval status of status approval is the What requirement changes that impact changesrequirement that product?the Are there regulatory there Are commitments or other periodic or other commitments reporting requirements? Did the approval contain contain approval Did the Was a communication received a communication Was from a regulatory and, authority actionif so,is required what and who should be notifi a proposed change require Will a variation If so, or amendment? in which countries? Figure 3. RegulatoryFigure Pl • • Communicate Product Information to Communicate Product Stakeholders • • • • 44 REGULATORY UPDATES

decision making. Critical intoday’s Critical making. decision to enable proper isneeded system therefore, accessible asingle,globally are notusuallyisolated to oneregion; and reliable iskey. Th and that the information isaccurate where that found, be information can what informationKnowing exists, Integrated Systems byanorganization. making andquickdecision requirements toare understanding regulatory critical information, and regulatory analyzing and updating, cross-referencing, indexing, compiling, of acquiring, onerous andtime-consuming tasks Th laws. bylocal to Englishwhenallowed andtranslations document the issued of language inthe local is provided Information countries andregions. inmany requirements the regulatory to understand information needed Th forrepresentatives information. in additionto relying ontheir local professionals, to their regulatory access to anddisseminate information orTarius, IDRAC as to help provide such intelligence services, database tocompanies regulatory subscribe To avoid this problem, many for translation. the need assimilateprofessional without can that a language the regulatory mayavailable in notbe obtained Inaddition,information consuming. right istime regulation orguideline multiple tothesearching sites locate information. However,to critical professionals access regulatory thus providing products, medicinal of andregistration development informationand locate related to the ability toprovided search Thhas evolutionof the Internet e Intelligence Regulatory GLOBAL FORUM ese databases bring together allthe bring databases ese registrations. submissionplansand managing and producing, planning, ese databases can replace databases can ese the ese ese decisions the many that updates may occur andfitargets le content, through to the planningofregistration early from ofaproduct, entire life cycle the that solutions integrated support to areCompanies nowlooking functions. reporting basic perform andaninability to applications, status or ofdossiers or agency to the as corporate understanding alackofcommon global enterprise, to ineffi led ofinformation. Th this type management to convey systems to extendhave looked document many companies In the past, plan to the teams. product andcommunicateand resources, this eff and interpret information to globally professionals able must to be access Th organizations. professionals inlife sciences makingbyregulatory decision foravailable appropriate iscritical information product regulatory oftheunderstanding complete an orannual reporting, follow-up for commitmentexpectations the orunderstanding variations, byamendmentsand caused obsolescence document identifying licensing indozens ofmarkets, maintaining product submissions, availability for inclusioninupcoming internally, adocument’s tracking versions ofCMCandlabeling content Whether communicating the offi authorities. and approved byregulatory reviewed information that been has communicate the eff content; andtrack regulatory ofassembled manage collections support; information to aidindecision product detailed manage, andanalyze marketplace; aglobal across collect, orregistrations authorizations manage,andtrackproduct collect, that enable acompany can to centrally marketplace system isanintegrated ectively plansubmission workload ectively ciencies ciencies across the e e regulatory ectiveness ectiveness of is has cial confidence inthe information. with decisions and registration effi ciently development makeproduct enables companies to eff framework with agloballydeployable ofthis Provision information goals. activity,line, regulatory andbusiness a relationship to acompany’s product to haveletters to submissiondossiers, information, correspondence from component alloweach of history andsubmission objectives, business applications, andplanned submitted of related products, andwithin of the information inthe context Provision ofyears. over anumber editorial board. editorial Forum’s of the Global amember is [email protected]. Youfor Liquent. her at contact can Strategies ofRegulatory Director theExecutive is Sarah Powell making. decision to empowered information –at the right time–iskey to France, access to the right acceptable formulation to shipthe new whether itis ordeciding trials, clinical for requirements global regional ofthe anunderstanding developing market inmind.Whetheritis the with global plans andsolutions andimplementing understanding, compliant companies are accessing, information. regulatory- Successful, solely onregional based decisions is nolongeracceptable to make In today’s it globalcompanies, Conclusion ectively ectively and ■ PROFILE 45

GLOBAL FORUM GLOBAL How didHow you become a regulator? earned in 1983, became PhD my an of OB/GYN in Associate Professor 1989, and a full professor in Medical Epidemiology in 2000. My thesis project,My based on the build-up of a cohort of women taking estrogen, was actually done Medical with the in collaboration meant that Products This Agency. I had support from of Drug its Unit time headed that late by the at Safety, and becameBeje known Wiholm, at as a researcher field in the MPA the years Ten of pharmacoepidemiology. when I was appointed professor later, Karolinska Institutet, the I wasat offered a position as Unit Head of the which I of Drug Safety MPA, of the assumed and accepted 2000. The in position several meant demanding tasks, head being administrative the of some 25 staff members, being scientificin the lead of activities, a London to once and traveling in the MPA the represent to month Party Pharmacovigilance Working CHMP. of the (PhVWP) was This level the a time when kept on MPA of ambition of the increasing, take ie, aiming to on responsibilities a large for number of Rapporteurships for new products EU network in the postmarketing follow- system. For an escalating meant work up this and newburden responsibilities in EU pharmacovigilancethe work. task work,A central in my as I What isWhat your professional training? I obtained MD degree my in 1975 specialistand my in OB/GYN licence I academicin 1980. As career, my to through linkage national with the through Cancer Registry of Sweden. Several followed,publications reporting on a substantially increased risk this for cancer in long-term usersof estrogens epidemiologicalalone (confirming US), but a protection from data the against increased the risk if had beenprogestogens combined dissertation on estrogen. My with the a thesis ”Endometrial entitled cancer risk after estrogen and estrogen- at took treatment” place progestogen in 1983. University Uppsala the field the into is how I ventured This while still of pharmacoepidemiology, activeremaining as the a clinician. In I combined a clinical years follow, to with in OB/GYN practice increasing activities in epidemiological research 1997, From University. Uppsala the at I had a full-time positionin research. I moved newly the to same year, That established DepartmentMedical of Karolinska the Epidemiology at and wasInstitutet appointed professor of Medical Epidemiology research afterin 2000. My thesis has the presenting addressed importancethe of reproductive and molecular genetic factors and hormones to exposures as causes of breast, ovarian, and endometrial cancers as as well cardiovascular diseases and osteoporotic fractures. INGEMAR PERSSON PROFILE OF PROFILE When did you first become interested in When training to becomeWhen training to a specialist in Obstetrics and Gynecology (OB/ GYN) mid-1970s, in the I was made about an increased of concerns aware risk endometrial for cancer after (HRT) therapy hormone replacement in postmenopausal women. Through advice from epidemiologists in countries,Sweden and other I realized to be it would favorable quite that perform epidemiological studies on in Sweden. I was topic this as accepted Department the at a doctoral student University of OB/GYN of the Hospital Uppsala, in Sweden in 1977. A projectwas a launched for designeduniquely epidemiological ie, a prospective cohort study, with collaboration Through study. pharmacies region in one large of Sweden, all prescriptions for therapy estrogen replacement collected, were (ERT) and data prescriptionfrom the forms on the product exclusive with together the patient numberidentification of the a computerized. way, were In this cohort of over 23,000 estrogen users, prescription cumulative with their data, was built up during a three- year period fromThe 1977–80. endometrial in the cancer outcome cohort subjects was ascertained pharmacoepidemiology? What happened in your career? next Senior ExpertSenior at Medical ProfessorProducts of Agency, Karolinska Pharmacoepidemiology, Institutet, Sweden 46 PROFILE

ENCePP system). ENCePP collaboration the within EU(likethe and ofnetwork systems development and databases), and clinical Registries (likeQuality in Sweden resources for pharmacoepidemiology and methods new developing (RMP), (PASS) Management Plans inRisk to studies Postauthorization Safety mostly pertaining issues on scientific opiniondiscussions include second bytheMPA. given These tasks with days ofthe at week the CPE, thatthis means Iaimto work two Inpractice, the Institutet. Karolinska of ofInternal Medicine Department ofthe (CPE) Pharmacoepidemiology Epidemiology,Clinical Centre for for the MPAperson at the Unit of acontact as since 2009,serving role another new I have assumed May 2010. atPharmacovigilance the MPA since Person for Responsible and Quality Expert Senior as held aposition Ihave MPA. ofthis work, Insupport at the activities pharmacovigilance andsupporting to developing turned was Nowthe focus management. pharmacoepidemiology, andrisk for pharmacovigilance, responsibility 2005-2009with ofthe CHMP expert 2000–2005andCo-opted CHMP the MPA delegate to the PhVWP/ Iwas Thus, (EMEA). of the EMA at the MPAactivities andat the level more order onthe toscientific focus administrativein head, as step down the chance given to In 2006Iwas reporting. ADR spontaneous such as in additionto routine measures the ofpharmacoepidemiology, field in to methods apply scientific need andisthat thereconviction was isa my Thus, possible. much as as andminimized assessed, detected, could inuse be drugs with risks to ensure thatpharmacovigilance, in tools andeffective new support toand advocate was it, perceived GLOBAL FORUM safer drugs andsaferofdrugs. use safer drugs to promote pharmacoepidemiology to applywanted my experience of I because person am aregulatory andstill In summary, Ibecame management is done. In many RMPs, management isdone.Inmany RMPs, ofrisk oneffectiveness follow-up and needed; as recommendations, complianceby proper with risks tominimize measures implemented; are directly methods high-quality pharmacovigilance and tailored market introduction; before are proactively defined risks important potentially great; is ofRMPs The benefit of RMPs. management bymeans systems to submitplansfor risk (MAHs) holders market authorization byobliging products for new of risk thethat enhanced management has legislation the EUimplemented new In2005, needs. to these reacted has system The European regulatory introduced. andsafetyare being of efficacy interms both uncertainties pose therapies that advanced called New, themarket. entering so- are effects adverse on long-term there isconsiderable uncertainty New, for which products innovative safety. ofdrug surveillance better public may for have expectations andslow.ineffective Further, the seems system pharmacovigilance that theraised postmarketing The been issuehas NSAIDs. cox-selective some with events ofcardiovascular risk increased ofstatins and use after cases rhabdomyolysis fatal eg, products, medicinal some with experiences fortunate ofless a number ADR There haveover recent years. been apparent increasingly become has risks managedrug better It to methat isclear to that the need products be best managed? best be products ofmedicinal risks How can meant recommendation. isawell pharmacoepidemiology and timely trainingin good Therefore, methods. epidemiological observational, chiefly of methods, array awide about knowledgeable and perspective of the life cycle aware to be need pharmacovigilance for Professionals responsible stake. isat safetyandefficacy, for both continuous pharmacovigilance Therefore, ofthe drug. life cycle the them, entire during between andthe balance andrisks, benefits tohave monitor aresponsibility agencies companies andregulatory Manufacturing use. in real-world are whendrugs efficacy, well as for Thissafetyas health. goes implications forimportant public mayThe have ofdrugs use work? pharmacovigilance this cause. iscentral to pharmacoepidemiology The of anduse development products. of allmedicinal managementfor improving risk promise agood bears legislation, strengthening ofpharmacovigilance thetogether with emerging strategy,In my opinion,this new ispending. guidance andrevised agencies by regulatory is presently upfor consideration management practice for risk Best andfeasible. relevant should be requested the measures products; to proportionate theto specific be isessential. need RMPs agencies, applicant companies andassessing by experience, from both Learning The recent. isfairly practice ofRMPs work ofthe regulator. to inthis the are field skill crucial that experience and Ibelieve tools. (PASS) the necessary as are used studies pharmacoepidemiological to people active in in active to people wouldyougive What advice PROFILE 47

■ GLOBAL FORUM GLOBAL work it may be less it may work physically or stressful, least at strenuous effortswhen comparing during call to nights as a clinician. In relation full-scale academic work, is there aboutless finding concern time to research for funding.apply Also, being in a as I mentioned earlier, position actually make decisions to basis the on or recommendations of research findings often gives one a good feeling. and a career work The itsas can special have a regulator Deadlines could burdens, however. be difficult cope with, especially to regulatory time. The during holiday system is sometimes a bit rigid and bureaucratic, with restricted degrees of freedom are action. for And, why pages always so read many to there in regulatory documents? I believe though, On balance that beginning as moving a clinician, research, and ending up asinto represents a gooda regulator all of In progression in a career. these areas, find balance to ways the between and spare time enjoyment own career ambition is in one’s hands. pleasure and meaning Finding walksin all the helps, too. How are you able to balanceHow life and career as a regulator? How hasHow your job in pharmacovigilance had an Life as hasLife a regulator its advantages. clinical to In relation impact on patients, consumers, or others? As a clear is mentioned, there health responsibility the defend to and benefits of consumers of the drugs. Good of risk management with tailored and good standard scientific methods has potentially an important positive impact. (happens sometimes) results. Now it is becomehaving a regulator, it is even that experience more my experiences from inspiring apply to research in decision making. In words,other by being read, to able scrutinize, from data and interpret one canepidemiological literature, is a knowledge there that experience base take actions, to formulate ie, to restrict use or to recommendations safety as as well improve to in order efficacy. What jobWhat experiences have you found especially change in pharmacovigilance What isWhat the most important As a researcher in it is exciting pharmacoepidemiology, newand inspiring investigate to hypotheses important and publish interesting/inspiring? For a very long time, triggeredFor by the disaster 1950s, in the Thalidomide spontaneousthe card”) (“yellow system has been of mainstay the pharmacovigilance. years, In recent a new strategy has taken shape. Risks assessedare time the at proactively managing a plan for of approval, risks is part and measures approval, of the detectingfor and minimizing risks as product put in place the are is taken market. new up on the This to manage risksway has, in my opinion, given a greatly regulators opportunityimproved monitor to and assess benefits and risks for medicinal products and thereby power public health more defend to of drugs. use the to in relation that you’ve seen ? you’ve that Paul Pomerantz, Ric Day, Margaret Hamburg, Gaby Danan, Yves Juillet, and Jeﬀ Sherman Annual Meeting Orchestrates “New World” Symphony

IA’s 46th Annual Meeting evidence-based medicine, health “We’ve become a truly global plenary session began with technology assessments, and new association, as demonstrated by the D the Bel Canto String therapeutic approaches.” international composition of our Quartet’s performance of Dvorak’s Board of Directors,” said Dr. Day in New World Symphony, which DIA President Dr. Jeff rey Sherman his fi rst remarks as DIA President. introduced a program devoted to a thanked his Board colleagues “Patients have the same general new vision of health and health care whose terms are ending, before needs, no matter where they live for the entire world. introducing the 2010-2011 DIA or where we work,” he continued. Board of Directors, ending with the “We’re committed to including the “Th e problems aff ecting today’s Executive Committee, which consists voice of the patient in our programs health system are truly global – of Dr. Sherman, now Immediate and deliberations.” from the need to assure access and Past President; Dr. Richard O. Day, quality while controlling cost; the President; Dr. Yves Juillet, President- “We all have much to learn from safety of the global supply chain; Elect; Minnie Baylor-Henry, each other. When the best minds and the challenge of fi nding cost- Treasurer; and Paul Pomerantz. work together in these diverse but eff ective therapies for chronic, “As I pass the DIA Presidency onto independent DIA forums, innovation neglected, and emerging diseases,” Richard Day, we will witness a and collaboration happen – and said Worldwide Executive Director historic time in the 46-year history so do better health outcomes,” Ric Paul Pomerantz in his opening of DIA. It will mark for the fi rst time concluded. remarks. “Th is 46th Annual Meeting an Executive Committee comprised is a step in our evolution, with a of a DIA past president, current “Th is year’s Annual Meeting will focus program that includes collaboration president, and incoming president, on innovation and the factors that among industry, academia, who represent three diff erent areas help to facilitate it. By innovation, we regulators, and patient advocacy of the world – North America, the mean not only innovative products groups, to address major issues in Asia-Pacifi c, and Europe. Clearly, but innovative services to patients, to

NORTH AMERICA NORTH health care, such as comparative this transition embodies our global pave the way toward the future and eﬀ ectiveness, health outcomes, perspective and purpose,” Jeﬀ said. better health outcomes,” said Annual 48 GLOBAL FORUM NORTH AMERICA 49

ort ects for for ects GLOBAL FORUM GLOBAL eld of eld focus, and and intellectual it needs,” that dollar investment she said. “In fact, billions of beendollars have invested in biomedical research, an eff is obviously indispensiblethat medicalfor progress. But this research into will not translate real-life therapies for those who need them unless we make in investment an appropriate can no regulatory science. We on techniqueslonger rely and e science and tools we need of regulatoryeld science – truly as diverse as genomics, synthetic research, and cell stem biology, promise the hold nanotechnology, therapeuticof major advances. But we all recognizeI think a gap that has formed between biomedical research the one hand and on the development of these new potential she said. “We medical products,” need and I believe gap close to that one we can. now, But right that of doing so is critical component lacking.” “Th assessto and evaluate a product’s quality and advocacy, safety, performance words, – in other the fi has not received attention, the approaches of the 20th century for review prompt the of and approval prevention, and cures treatments the 21st century.” of the “Regulatory is, science after all, the critical bridge between biomedical research and new medical products she people for who need them,” fi strong “A continued. regulatory science can make the in speedingerence evaluation the diff of new products, tracking safety, recognizing in problems potential products wasted avoid earlier on to honing in on the time and money, value of certain work, drugs may that side eff have may or that targeted subpopulations, list and the goes on.” ects ects elds is y recounting recounting y is morning, is of regulatoryeld science the fi the and responding globalization, to especially issue of import urgent the ese areas I are know are that Th safety. of great importance mission the to and activities of DIA and where enormous are opportunitiesthere for fruitful collaboration.” of knowledge explosion the “With and capabilities emerging from domains of research and many globe the from around a comes fundamental question: do we How we fully translate that make sure and promise of that potential the real-worldresearch products into We really matter? and programs that developments continuing know that in fi in science and technology, her personal career returned path, theseto challenges. “Th cally on two focusI want to specifi of these challenges: Strengthening all that we do, for better and for better for we do, for and all that time when we live in a worse – that science and technology changing are ways. in dramatic our world Th opportunities ers huge improve to off health and prevent disease. But, to fully realize advancement the them, discipline of regulatory the science, very the at heart of our mission at FDA, become must priority a top for and, in fact,us and our nation all for nations.” Hamburg, after briefl Dr. “We must recognize must we live in a that “We globalized aff – a fact world that the ll its is a mission today “I have been is this “I have that told Keynote Speaker Commissioner FDA discussed Hamburg Margaret Dr. of DIA, nature collaborative the and DIA-FDA relationship, of the can both help how collaboration organizations meet our current challenges. agency“Our faces perhaps more usual number of crucial the than public health tasks. But I also believe job the of empowering the that fulfi to FDA Meeting Chairperson Dr. Gaby Gaby Meeting ChairpersonDr. speakstheme to is year’s Danan. “Th work we must innovation and how innovation for facilitate to together better health outcomes.” biotechnology for event attend to pharmaceutical and regulatory certainly an professionals, so it’s be me to part honor for of this is work she began. “DIA’s program,” very not only valuable, but it’s in syncmuch priorities with the FDA. of the and concerns Your mission of fostering innovation of information exchange and the is important, really critical, the to health and well- future of the being of people worldwide. You global forum, provide an essential appreciate FDA the and we at country you do in this what and DIA world. the around represents a very important partner FDA.” at organization our work for and far more erent fundamentally diff proposition it was than complex even keenly a few aware years ago. I’m chief priorities one of my asthat be must accelerate commissioner to into FDA of the transformation the a regulatory agency fully capable and protecting of promoting the Americanhealth of the public in the and it starts with the 21st century, powerful are recognition there that which we to our world shaping forces adapt.” must 50 NORTH AMERICA

GLOBAL FORUM eff scientifi to harmonize orts including international activities, rangeof we are inawide involved continued Dr. “Today, Hamburg. industry,” andwith organizations, other international andnational authorities, our sister regulatory Th with means workingclosely is achallengeweallshare.address to that webuildpartnerships “Th urgent that it.” weaddress many andit’swith other nations, Thblurred. isachallengeweshare increasingly becomes foreign products and domestic the between distinction consume continues and to increase we products percentage ofimported Dr. Hamburg day, said.“Every the commodities,”are global inreality what weconsider ourproducts is eff andmarketed developed discovered, weregulate are which the products “At the sametime,the world in e new global reality requires requires reality global enew ectively getting smaller and getting smallerand ectively otc st er o ecnspotyu lncltil twww.neirb.com at trials clinical your support can we how learn to us Contact

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e cally p ro v id e f l e x i can identify many for more areas identify can andwe priorities elements ofthese together that support in activities engaged we’ve been Infact, and DIA. FDA for collaborationareas between are ripe ofglobalization challenges andthe science regulatory “Both endeavor.” isaglobal protection public health thathave metimeandagain shown throughoutexperiences my career –my products andmedical food importantly, the nation’s supplyof – people ofthehealth American commissioner the isto protect And although myFDA dutyas mechanisms. information-sharing informationand systems developing and andindesigning systems; andassessment surveillance detection, strengthening, with assist requirements; andimport disciplines training inapplicable regulatory b and t share scientiﬁ standards; rigorous i l i t y echnical expertise; provide provide expertise; echnical

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n concluded. importantly,most to allofyou,” Jeff staff and members, , to ourboard to ourdedicated our volunteers, all ofusto work together –from reinforces itisfor justhowintegral ofwhat wedoalso the dynamics for me, But, of ourassociation. the underscoring value to market, safe andeff products health ective inthe way webring of usto evolve isforcing all landscape changing “Today’s President. DIA as remarks for hisfi to the podium returned Jeff these After awards, awards. Information Journal, and Drug volunteer andcommunity service, to present DIA’sthe podium annual Jeff thiskeynote, After she concluded. ofthe 21stcentury,” decade second that moveusintoagendas will the define the scientifi c andpublichealth wecontinue as togreater partnership to even forward Ilook future work.

l e s . 1 4 3924 243 617 ■ returned to to returned nal NORTH AMERICA 51

Campbell University University University University GLOBAL FORUM GLOBAL ■ Congratulations to all of our student all of our student to Congratulations poster presenters. University Mrs. Adrienne Faerber, of Wisconsin Clive Mario Mendonca,Mr. of Mississippi University Ms. Jeongeun Seo, College of of Houston University Pharmacy, Dionne Renee Glast,Dr. University Dhruv Sohanraj Mehta,Mr. Medical National College; Topiwala Charitable Nair Hospital, B.Y.L. of Health Maharashtra University Sciences, Mumbai Aria of Ahmad, University Mr. Toronto Pankdeep Chhabra, University Dr. of Maryland Preciosa Coloma, M. Dr. Erasmus MedicalUniversity Center, Rotterdam University Temple Lindsey Pelletier, Shirish Abhishek Chitnis,Mr. of Houston University Ms. Sigrid A.E. Nelson, Ontario, Robarts of Western Research London, Ontario Institute, of Jeetvan University Patel, Mr. Houston Miss Zainab S. Shahpurwala, of Mississippi University Ms. Surender Jhanvi Bajaj, Seth G. S. Medical College, Mumbai Soumil Shrihari Patwardhan, Mr. Seth G. S. Medical College and K. E. M. Hospital, Mumbai Ms. Michelle L. Campbell, of Maryland,University School of Pharmacy Miss Allen, Cardiﬀ Nicola UK University, of Macau, Bai, Jishan University Mr. Macao, China Shah, Northeastern Nisarg Mr. Boston University, Annesha White Lovett, of Florida e published in the July issue e published July in the accepted and the posterthe and accepted abstracts wer Drug Drug (volume 44, number 4) of the Journal. Information was place won by Mrs.First of University Faerber, Adrienne Comparison for of Wisconsin, Advertisements for Television Products Switched That From Prescription Benefits, to OTC: Risks & “Switch-Related” Appeals Second was place by Lindsey won for University, Temple Pelletier, An Analysis of Ethnicity-Related Labeling Divergences Among Products in Approved the United States, European & Japan Union, Between 2007 and 2009 place was ird won by Ms. Jhanvi Th SethSurender Bajaj, G. S. Medical for College, Mumbai, Assessment of Severity, & Economic Preventability, Burden Due Adverse to and Events DrugAdverse Reactions Occurring in the Medicine Intensive Care Referral Care of a Tertiary Unit Center e Sherman Copenhagen Temple University Temple session was held on Monday, session was on Monday, held E. Walter the 14, at June he 2010 Student Poster Poster he 2010 Student Dr. Barbara Gladson,Dr. Dentistry of New Jersey

Dr. Albert Wertheimer, Albert Wertheimer, Dr. University of Medicine and University North Carolina, Wilmington University of University James Polli, Dr. Maryland School of Pharmacy University of University Spindler, Per Dr.

University of University Kris Walters, Dr. DIA thanks the members of the Professional and Student Poster Committee Th is year, international graduate graduate international is year, Th submitted 69 postersstudents for Meeting. Annual the inclusion at these submissions, From 20 were presenting.

Washington Convention Center. Th Center. Convention Washington posters presented were from 10:00 am Exhibit in the Hall, and the 6:00 pm to 3:15 at took place ceremony awards with DIApm, Jeﬀ President T Jhanvi Bajaj, Adrienne Faerber, and Lindsey Pelletier at the awards Lindsey ceremony. Pelletier and Faerber, Jhanvi Bajaj, Adrienne

Presented in DC Presented Student Poster Awards Poster Student 56 NORTH AMERICA

Kellie Bemelmans GLOBAL FORUM A delighted to find the meeting welldelighted the to meeting find attendingwas bymyself. Iwas andI my meeting first this was I wasn’t as sure what to expect, to networkat the exhibition. the well opportunity as as sessions I wouldhave access to of hundreds Iknew this spring. Annual Meeting student to scholarship the DIA a awarded Ihadbeen learned elated whenI Iwas all.So after or to through read aCRO’s SOPs, atrial, to observe show upandask world experience. Onedoesn’t just onreal- andshort learning book Wilmington,Carolina longon Iwas at the University ofNorth program Research Clinical s a rising senior inthe senior s arising woman next to me;Icould see to the perfectly-coiffed apologized Iquickly inmy shoe. and lodged my my slid down legoff coffee, bagel dropped cheese-covered my cream the surroundings, in taking Iwas atmosphere. As heightened the Quartet String Canto and theof sounds Bel to myself. Dimbluefloodlights career,”my new Ithought proudly the from industry.leaders is “This thought global with filled ballroom, Ientered themy as elegant coffee my balanced bagel oncarefully andI session, plenary opening Dr. Hamburg’s comments at the excited to Iwas hearmorning andfriendly.open, Monday helpful, andeverybody organized, it isheaded. isnow,the industry where but also not onlyofwhereunderstanding the industry, toanorganic get the trends in to observe was tothe astudent Annual Meeting of that abenefit Irealized DIA. collaboration ofthe FDA and through met could challenges be these Shenoted addressed. be safetymustthat product global and to market, products medical to bringing discovery/innovation drug from inmoving is crucial science thatmessage: regulatory Dr. into hear settled Hamburg’s my regaining composure,After I herleg. dare down bounce right away that abagel wouldn’t NORTH AMERICA 57

GLOBAL FORUM GLOBAL ■ Kellie Bemelmans isKellie a senior Clinical Research student at the of North Carolina University can contact her at Wilmington.You [email protected]. own enthusiasm. I remember I ownenthusiasm. feeling a great deal of pride in Clinical Researchmy program Everything described UNCW. at sessionin the was familiar quite me, down everyto to referenced section of 21CFR. was It exciting discuss in the to information the of being an emerging context professional. Everything experience about the was positive I love me. for DC,Washington and I walked to Smithsonian everythe evening to and begin unwind what assimilate to Standing I had learned each day. Dutch in the Vermeers before the National the at Masters’ exhibition Gallery of Art, back I thought performance of Belto Canto’s Symphony, New World Dvorak’s a perfect a conference to preface on facilitating innovation for better health outcomes, as we challengesface the and rewards of globalization. I decided it was an extraordinary be to time an in this emerging professional industry. But games aside, the exhibition hall But games hall aside, exhibition the proved a wonderful opportunity network and meetto people who Everyone worked industry. in the I spoke with was encouraging, supportive, and interested in hearing about Clinical the I, UNCW. Research program at part, my for was eager hear to aspectsabout different the of the industry speak and to recruiters. to As a a student, I did not have business card, so beforehand I had some printed with my front on the information contact and career and degrees interests earned on the back. I handed out almost of these. a hundred fishbowls into went many Granted, iPad drawings,for also but many hands of recruiters. the into went I took careful notes as I spoke with individuals and again upon each evening. hotel the returning to follow- my when I sent way, This up emails, I would remember the individual with whom I spoke and specificsthe of our conversation. been I have in regular Ultimately, with recruiters from contact companies, exhibitor three of the and I will be likely scheduling an interview shortly with one In a downof them. economy, opportunitythe speak to with recruiters directly and shake their hand cannot be underestimated. reason this Annual alone, the For Meeting and of course is invaluable, opportunity is the added to that to learn sessions. all of the at session favorite wasMy “An Overview of Drug Development for Every bit Emerging Professionals.” of it was relevant, and engagingly presented speakers. by the I could they passionate about tell were careers,their and it added my to e ected onto onto ected One of my favorite things favorite wasOne of my hall. exhibition the networking at escalators, of the top the Standing at I was observe to able scope the of the meeting 480 exhibitors’ than – more booths all aspects representing of industrythe Th world. across the With this in mind, I arrived in mind, this the With morning at (sans bagel) next plenarythe CER session. Dr. Goldsmith described how CER was of health care a centerpiece more would allow for and reform informed decision making. As the panelists shared views their about CERhow the model would affect deliverythe of medical services, a question was mind. forming in my card So I submitted a comment assured are question: “We with my CERthat will not be tied the to denial of services disabled, the to etc., but terminally ill, elderly, of limited in a world realistically, dollars,health care how can this be?” I was surprised and proud handfulthe of of audience that Goldsmith Dr. questions that asked, he included mine. As I sat response the to my listening to question, I realized again how the I wasfortunate attend to Meeting.Annual fun. was,atmosphere simply, quite attendees were and exhibitors e Th smiling and sharing information, and I took part playfulness. in all the cards read, tossed Tarot I had my beanbags win to prizes, a chance for and played a game you stomp where on “bubbles” – lights reﬂ carpetthe try – to outscore your to opponent. was It during game, this competitivenessas natural kicked my in and I was with vigor, stomping I realized was this that that perhaps ed in which light mostnot the digniﬁ a potential to myself present to employer. 58 ON LOCATION: OTTAWA & theNation’s MajesticCapital Cornerstone ofCanada’s High-Tech Industry

GLOBAL FORUM T and even livemusic andtheatre toand even enjoy. You ahot-air take can publictennis clubs, golfcourses, parks, plentyalso ofmuseums, For Parliament attention, Hillattracts visitors, butthere are commute to work orschool. abreezy, oras either for fun fresh-air ice rinks) Olympic-sized world’s “skating largest outdoor of90 (the equivalent rink” onemillionskaters glidealongthe year where each skateway into turns to March Canal the afrozen January Rideau from Meanwhile, aplayground forandtourists. as boaters recreational serve waterways whileits motionofbikersandjoggers perpetual are bustling the Canal with the Rideau alongside walkways andsummer, clubscene. Inspring andanactive restaurants the countless with eclectic infused vitality acityofendless become has underthe 900,000residents ageof35,Ottawa half ofits “Silicon itthe Valley designation earned ofthe North.” With nearly whichhas afact companies, andmodern-tech med-tech research, myriad today’s world styleParliament boasts buildings, Ottawa Canada. And, while its skyline is dominated by its old- isdominated byits skyline And,whileits Canada. River,River, Lawrence ofthe St. inOntario, atributary he city of Ottawa rests along the banks ofthe Ottawa alongthe banks rests he cityofOttawa ON LOCATION: OTTAWA 59

GLOBAL FORUM GLOBAL er numerous numerous er of 1,000 settlers becameof 1,000 settlers known as overseer. Bytown after project’s the canal the wasOnce completed, became settlers in 1832, the the powered that a thriving workforce was in high Timber lumber industry. shipbuilding demand in England for the and century, mid-19th in the on dense forests would later region’s serve as a valued lumber for source the United States. in 1857, the ve years later, Twenty-ﬁ growing city would be chosen by Queen over contenders Victoria, Toronto, QuebecMontreal, City, becomeand Kingston, to capital the Britishof the Provinces of Canada. Regarded as a surprising choice it did oﬀ by many, advantages: and its canal, railway, by France’s Samuel de Champlain, de Champlain, Samuel by France’s area quickly becamethe the via St. entre, the European Lawrence boundless interior Canada’s to River, it riches.and its natural However, a permanentwas 1826 that not until would besettlement established here. John Colonel Lieutenant year, In that By was charged with supervising the construction Rideau of the Canal. 126-mile canal the completed, Once would not only connect to Montreal Kingston on Lake Ontario, but would provide a strategic military supply ability bolstering region’s route, the to thwart a possible attack. Irish immigrants and French Canadians from Quebec descended canal, build the region help on the to new community and the merchant

(French) to find find to (French) Th e region e now occupied by Ottawa Th was Outaouak, the home to once an tribeAlgonquian fur-trapping from city deriveswhich the its modern-day name. After being discovered in 1613 Ottawa’s Story: Settlement to Settlement to Story: Ottawa’s Seat Government balloon test your ride year-round, Casino the luck at du Lac-Leamy in nearby see Gatineau, an Ottawa Senators hockey game, in or stay boutiquestown and shop the of the Byward Market area. There’s clubs,no shortage of late-night restaurants, and bars – so, pick up weekly of the Ottawaa copy Xpress (English) or Voir happening in Ottawa out what’s visit simply Or, and Gatineau. www.ottawaxpress.ca. 60 ON LOCATION: OTTAWA

GLOBAL FORUM place, and other downtown hotels. place, andother hotels. downtown take will Meeting Annual Canadian the Westin where DIA’s Ottawa, 8th optionsfor reaching have several and (YOW) International Airport at Macdonald-Cartier the Ottawa 3 millionvisitors. annually bymore enjoyed area than andforest andan lakes, mountains, by anatural playground hills, ofski beauty. It isacitythat issurrounded today enhance Ottawa’s and charm that areas andwooded drives parks, inthe shape scenic took His ideas a beautification planfor the city. creating with charged Gréber was War II,French Jacques architect Following Worldrebuilding. on sights its set 1916, Ottawa byfi Besieged ofCanada. Dominion suitto following creategradually the nine other andterritories provinces the and confederation ofCanada joining Scotia andNova Brunswick New federation with a united later,years became in1867,Canada Ten right. was the Queen Indeed, werehouse erected. London’s Westminster Parliament reminiscentof gothic buildings of in1859,andaseries began capital ofthe Construction provinces. both government here might help to unite felt thatQueen placingtheof seat the (Ontario), Canada and Lower (Quebec) Upper Canada of both proximityand close to the borders Moreover, populace bilingual its with defensibility to nameafew.military (www.yowshuttle.com). Ifyouoptfor roundtrip person or$25 per one-way hotelperson a downtown is$15 per Transport area. to 1Arrivals Level Postfrom the airport’s 10 justoutside Th Shuttle edeparts YOWAirporter Shuttle Airport Th Getting Here, Getting Around ose ose fl ying into Ottawa will land into will ying Ottawa re in1900and pay around $29. to to yourhotel expect instead, a taxi edge of downtown Ottawa. ofdowntown Ottawa. edge onthe at Street 265Catherine located Th greyhound.com). (www. the USandCanada between busservice provides Greyhound another alternative, As your passport. Highway 417West. sure to bring Be toward Montreal andthen pickup I-89orI-91andtravel via Canada to Route 417.From Vermont enter toward Montreal headed Quebec I-81 to Highway I-87to 401ortake travel York youcan the New US, State into from If youare Canada driving US toOttawa by CarorBus upyourvehicle.when picking Westin Hotel (11Colonel ByDrive) to the for Ottawa directions $55. Ask home. Th edailycost is around $35- car, leaving before sure to book be To onarental pricing the get best Rental Car www.octranspo.com. information, visit For area. more 1Arrivals the Level Th at area. the center ofthe Arrivals door 1 Transportation onLevel located Desk at the Ground purchased be can which ($1.25each) two bustickets cost $3.25inexact change or will option.It economical is yourmost Transpo,OC the publictransitbus, Public Bus Parliament ofCanada e bus departs from post 14 outside 14outside post from ebusdeparts ebusterminal is Market. Market. andByWardChâteau Laurier exploreyou can the Fairmont side,for example,while onthe east of Nature, Museum the Canadian Warthe Canadian and Museum, Parliament find Hill, side youwill Onthe west (Lowertown). canal” (Centretown) and“east ofthe intodowntown ofthe canal” “west youare on.TheCanal divides canal whichsideofthe know Rideau foot, Whenon distant attractions. most except for the isunnecessary A car You around Ottawa. walk easily can TownGetting Around by visiting www.octranspo.com. www.octranspo.com. by visiting Transporoutes andbusstops ofOC You yourself withthe familiarize can Public Transportation circle. P inagreen awhite with letter for signs look lots, If youprefer the municipal parking forthe any signs restrictions. parking sure to read butbe orcoins, cards Thmeters parking e accept prepaid hours), andyellowonly). (tour buses gray (one-hour), (two meters: green attention to the color-coded parking Pay challenging. make driving come endcan to dead anabrupt that or changenames and streets residential streets, blocked streets, diffi be here can While traffi driving light, c isfairly Driving inOttawa cult. cult. One-way ON LOCATION: OTTAWA 61

nd cantly cantly area where area where GLOBAL FORUM GLOBAL e cent gardens, cent e Park, and some ers museums, cafes, specialty some of Ottawa’s best restaurants some of Ottawa’s one-of-a-kind shopsand many handmade crafts,selling distinctive jewelry, fashionable clothing, and its quaint great souvenirs. With courtyardscobblestone and Market areaalleyways, the ByWard live, shop, and to is a great place Drive,dine. Along Sussex also you’ll Gallery National the discover of Canada Hill Park. and Majors Drive, along Sussex a short Further fromdistance downtown, you’ll Rockcliff the head into homes,stately magnifi beautiful Rockcliff spectacular views you. You’ll await pass residences of ambassadors the dignitariesand international as well ByWard Market ByWard four-square-block district Hill; not far from Parliament dress warmly to forget as but don’t can signifi drop temperatures Established in in early November. the today 1826 by Lt.-Col. John By, area off food shops, boutiques, galleries, and some nightspots. trendy Bordered and Murray, York, by Clarence, George streets, you will here fi nd and the very DIA’s 8th DIA’s see to is plenty and do — and ere Ottawa Boulevard it’s all within a few blocksit’s of your hotel. and food who are enthusiasts Wine after Annual stay the their extending Canadian Meeting plan want to may Ottawa Annual 25th a trip the to Show (November and Food Wine Civic the Centre, 5–7, 2010) at Landsdowne in downtown Park Ottawa. Looking a unique for Checkshopping experience? out the Parliament Hill, the Peace Tower, Tower, Peace Hill, the Parliament historic Rideauand the Canal’s working locks. Or you can walk upscale the through the shops at Sparks Street Mall and the majestic Laurier Chateau hotel. Fairmont Th miss the shops here and the beautiful shops and the miss the here depicts Street on Preston mural that in Ottawa. life Italian Downtown of center is in the Ottawa. is home to It Annual Canadian Meeting, Innovation and Access “Fostering which is being Drugsto in Canada,” Ottawa Hotel the Westin at held from November 3–5, fi you’ll where It’s heart city. of the neighborhood.Little Italy Corso Italia discover , and you’ll Find Preston Street, Preston Find also known as Ottawa’s or night, you can day enjoy Here, fresh pasta,gelato, or a fabulous meal with wine. Or, four-course you can sit and sip if you prefer, espresso with tasty pastry. Don’t Ottawa’s Neighborhoods Ottawa’s Like most cosmopolitan cities, a century of immigration has flavored Ottawa with an ethnic diversity and a multicultural of neighborhoods.palette Each has its own cuisine, ambiance, architecture, and shops. a For taste of Asian you can culture, Chinatown Ottawa’s explore you willwhere find foods delicious China, Korea, from Vietnam, Located and Thailand. just west of Downtown Somerset in the an amazing area,Heights there’s assortment of Asian restaurants and retail shops hand- featuring painted silk garments, jewelry, tea sets, and Asian cookware. originalThe inhabitants of arrivedChinatown early in the joined later by the 1900s and were influx of over 4,000 Vietnamese refugees 1970s. in the NOTE: All prices this in article are subject to change are and shown in Canadian dollars. However you choose get to around, see is certainly to plenty there and capital and within its do in Canada’s neighborhoods.multicultural Day passesDay can be vendor bought at city or the locations throughout operators $7.50. Bus bus for on the cannot make change so always carry is Ottawa’s e O-Train fare. exact Th the local transit train. rapid rail light can be purchasedTickets for $2.75 station the each change at in exact www.ottawalightrail.ca Visit platform. information. more for 62 ON LOCATION: OTTAWA

GLOBAL FORUM Château Laurier andtheChâteau Parliament Laurier at Wellington the between Street astaircase bydescending accessed com; be 613-234-4570) can Museum Canal Rideau in Rockcliff here hisresidence from transported Pearson, Lester winner Prize Nobel Ministerstudy and Prime offormer Visitors the 1940s. view also can nation the from 1920sthrough the the wholed Lyon King, Mackenzie Minister William Prime well as here 1897to from 1919,as lived including SirWilfred who Laurier inflfrom uential ministers, prime and contains items andfurniture Victorianportrays stylearchitecture aNational Site, Historic East), Avenue613-992-8142; 335Laurier House you’re here. plenty anddowhile more to see Th interest to Ottawa. add local that blendtogether to neighborhoods Th of the many are ese justa few orpub. café orunwind at a artists, oflocal works displaying the andgalleries boutiques stroll through quaintghost, andresident history ofits and learn Watson’s Mill,aworkinggristmill of Manotick. in the waterfront historic village andrelax sitback youcan River Just onthe Rideau southofOttawa General. Minister and the Governor ofCanada’s the homes as Prime the late 19th century. Th in likeinOttawa what life was See attractions. ofOttawa’ssome popular most whilevisiting views picturesque insome take andeven leaders, its government and Canadian about learn perspective, ahistorical Get Things toSeeandDo (www.pc.gc.ca/laurierhouse; (www.pc.gc.ca/laurierhouse; (www.bytownmuseum. e Park. e Park. Here, you can visit Here, visit youcan Bytown andthe Bytown e Laurier Laurier ere’s Rideau Canal Skating Rideau Canal (www.mint.ca; (www.mint.ca; Mint Canadian explore the Royal While inOttawa, homein 1838. hisfamily this as created Canal, ofthe Rideau locks the well lower as as Museum, Bytown built the edifi contractor Th McKay, omas whoalso and ofEngland.Stone mason Queen ofthe onbehalf ceremonial functions outthe and royal statesman carries since 1867.Th governors-general residence andworkplace ofCanadian the private as served has gardens, and woods ofbeautiful 79 acres magnifi amidst cent located structure, Th 993-8200; 1Sussex Drive). 800-465-6890;613- (www.gg.ca; Hall interiors ofRideau century tours ofthe opulent 19thguided enjoy ayear 200,000people About Bytown. called the smallsettlement as start got its ofthe citythat overview pleasant a andprovides building inOttawa Itmuseum. stone isthe oldest residence. It isnowthe Bytown the lockmaster’s family became of commerce, whilethe fortifi the growth facilitated instead canal confl the didnotmaterialize, icts fortifi political cation. Whenfurther amilitary as to serve 1827, was Th supplies. route for military thus creating astrategic transport andKingston, Ottawa to connect the War built was of1812,the canal After Canal. ofthe Rideau lock last ofthe view aclose-up Get Building. eadjacent builtin structure, ce the weknowtoday as is cation is of the National Gallery ofCanada. of the National Gallery Avenue, andGuigues Street infront Patrick St. between Drive of Sussex Th windows. original replace seventeen 1956and1961to between installed andthe VirginJesus andwere Mary of the from lives scenes depict which GuidoNincheri, by artist created windows, stained-glass and mahogany woodwork, carved features twolarge ceilings, vaulted of this RomanCatholic cathedral interior ofthe late Victorian style Th com; 631-241-7496;385Sussex Dr). (www.notredameottawa. Basilica 1880’s—the Cathedral NotreDame 1841andthe church—built between exterior ofOttawa’s oldest Don’t bythe unremarkable fooled be Mint inWinnipeg. Canadian coins at are the produced Royal Incidentally, Canada’s circulation worthwhile. especially the visit makes of this 1908 stone building, money, wing of modern inthe new exhibit the about history wonderful chance to pickupalarge A goldbar! Youcirculation coins. a get may even into non- that these producing goes the process andto view reservations for tour ahead Call engraved. minted, andhand- are designed, and numismatic (collector) coins Here,Sussex Drive). commemorative 613-993-8990 or800-276-7714;320 Revival architecture andfeatures Revival example ofneo-Gothic wonderful in1920.Th erected was the HouseofParliament which and Library Parliamentary original Th the includes eCenter Block sections. several Wellington of andconsists Street Th from be approached can e area stoppingwithout byParliament Hill. completegovernment wouldbe to theof seat Canadian No visit Ottawa’s ParliamentHill e cathedral is located onthe corner islocated ecathedral appealing espaciousandvisually elatter isa ON LOCATION: OTTAWA 63

Connext Connext cant cant GLOBAL FORUM GLOBAL e Canadian e gures, its geography, geography, its gures, about the country’s signifi country’s about the historical fi and its aboriginal inhabitants. cavernous CanadaIn the Hall, reconstructed, life-size settings variousrepresent periods in Th Canadian history. Museum, an IMAXPostal theater, Canadianand the Children’s alsoMuseumlocated are within this Designed award-winningfacility. by architect Douglas Cardinal, a native curvesCanadian, exterior the in the design be said to building are of the symbolic of nature. forces of the Learn plant about animal life, more the at environment and the life, Canadian Museum of Nature 800-263-4433 or (www.nature.ca; 613-566-4700; 240 McLeod Street). Observe specimens wildlife of native such as bison and moose; visit fossil gallerythe and learn about or takedinosaurs a walk through gallery bird the hundreds where of varieties on display. are of birds documentaries nature lively Watch reputed well dioramas the and enjoy of Canadian mammals painted by In Tillenius. artistManitoba Clarence one new renovation, a recent exhibit water vital the that role explores and in sustaining freshwater plays marine habitats, as as well human life. e Canada Science and Th Museum (www. Technology sciencetech.technomuses.ca; 613- 991-3044; 1867 St. Blvd) Laurent and fun is highly interactive for kids as as well adults. aboard Jump a steam locomotive, learn about leading Canadian or inventors, canoes how commercial discover become enough to table became profi a symbol of Canada. a model View CANDU Advance of the Reactor advances learnto about Canada’s Plus, nuclear power. in generating videos,explore—through interactive and games displays in the e own ight ight ce nd out nd rst Viscount Viscount rst erent erent ces, administrative administrative ces, General tours of Parliament General of Parliament tours planes and bombers.ghter East Block has historic four West Block contains West e e Ottawa’s Museums Museums Ottawa’s Ottawa has over 30 interesting 50 galleries.museums than and more just a few are you might Following if time permits. explore like to Aviation and e Canada Th Space Museum (www.aviation. technomuses.ca; 613-993-2010 or 800-463-2038; 11 Aviation Parkway), houses best one of the aircraft collections Th world. in the museum a chronology creates of aircraft history with its “Walkway exhibit. See a replica of of Time” “Silver Graham Bell’s Alexander poweredrst plane fl fi the Dart,” Th in Canada, view fi the passenger jet, and observe WWI and fi WWII helpedight develop Learn how air fl Canadianthe North or test out your fl skills in an interactive aviator stimulator. e MuseumCanadian of Th Civilization (www.civilization. ca; 800-555-5621; 100 Laurier St., which is locatedGatineau) across riverthe is probably in Gatineau most popular one of Canada’s museums. includes information It rooms portraying diff historic periods, including the offi original governor-general’s representing 1872–1878. representing Th Parliamentary offi and meetingspace, are rooms that not open public. the to TOURS: fi To year-round. available are visit information website: more the http://www2.parl.gc.ca/Sites/LOP/ view . To Visitors/index-e.asp#visitor proceedings see of Parliament, or to is in House or Senate the if either session, www.parl.gc.ca go to or call 866-599-4999. re is building is of 1916 which was retrieved after fi the Original Victoria Tower bell Tower Original Victoria Canadian confederation founders, and Queen Elizabeth II Statues of primeStatues ministers, gas fl lit ame within a fountain, gas fl the commemorate in 1967 to birthday 100th country’s Centennial Flame, a natural Flame, a natural Centennial Peace Tower, which was erected Tower, Peace WWI honor Canada’s in 1927 to and WWII soldiers Peace Tower of Parliament at dusk of Parliament Peace Tower Walking west of the Parliament west Parliament the of Walking buildings, view you’ll Supreme the Court of Canada. Th Courtreplaced Old Supreme the which was built in 1889 and was torn down in 1945. • • • • Also within the Center Block the: Also are Center within the sixteen sides, pointed arches, buttresses stone and contrasting work. replaced original the house It which wasof Parliament destroyed in of 1916. re fi the 64 ON LOCATION: OTTAWA

GLOBAL FORUM War Museum Morse Code 245 Sparks Street) answers some some answers Street) 245 Sparks 613-782-8914; currencymuseum.ca; (www. ofCanada the Bank Th Tower onParliament Hill. east located ofthe Peace aview Hall provides inthe museum’swindow Memorial are battlefi onanactual eld. Asingle trench ifyou that as youfeel makes arecreated suchas experiences, military actual and byportraying andphotography art, recollections, conflmilitary through personal icts refl exhibits Eight permanent inception byEuropean settlers. its from ofCanada history entire military 776-8600; 1Vimy Place) the presents 800-555-5621or819- warmuseum.ca; Th World Cup in1974. at the recognition top-ten achieved that team theski from abadge as wellof Famer as Cochand, Louis the 1936trophyincludes ofHall Th country’s ofthe sport. heroes commemorativeas items the from well as andother skis artifacts, skin andseal handmadewooden early See 613-722-3584; 960Scott Street). (www.skimuseum.ca; Museum Ski culture atCanadian the infl andits evolution, its ofskiing, the allabout history Learn save acolony onMars! shiponasimulated missiontorocket are “launched” ina in whichvisitors the exciting Don’t network. through adigital miss travelexhibit—how messages e Canadian War eCanadian (www. Museum e Currency Museum of Museum eCurrency exhibit Space in Canada uence on Canadian Canadian ect is National Gallery ofCanada National Gallery interesting viewing. Or see works by works Orsee interesting viewing. make also andwhalebones soapstone from andsculptures Inuit prints painting “Thfamous Red Maple.” e Seven,” A.Y. well as as Jackson’s “Th as known artists e Group of Tom Th andhisaffi omson of paintings landscape wilderness are the Canadian included art; anddecorative paintings sculptures, containsDrive) 800examples of 2787 or613-990-1985;380Sussex (www.national.gallery.ca; 800-319- Th Canada of eGallery National counterfeiting. exhibit on afascinating includes also Parliamentfrom Hill,the museum blocks justafew and Rome.Located Greece China, suchas civilizations, amongearly use its about facts Th2500 years. historical isincludes throughout the world overthe past the ofmoney development depicts commemoratives also coins—it France New from andpresent-day money card as currency—such fi light-Although this pleasant, money? as were once used beans andcocoa beads glass grains, inst Forinteresting questions. lled venue emphasizes Canadian venue emphasizes lled ance, that didyouknow liated another visit. ■ another visit. your stay for orcome again back thatcapital you’ll to want extend anddoinCanada’sto see majestic Tha hotairballoon. soere is much the cityfrom orsee game hockey catch Senators anOttawa clubbing, dine at fi Ottawa’s goshopping, museums, You at watch, can listen, andlearn America. inNorth kind It isthe onlyoneofits Heart. Sacred ofthe Convent Lady Gothic ofOur the remains ofthe 1888neo- view andminimalism.Youart also can pop well as as andPicasso, Chagall system.” ofthe use publichealthcare by longevity, andeff lifestyle, inthe world “ascountry measured theis to healthiest makeCanada Th eultimate HealthCanada goal of maintain andimprove their health. that organization helpsCanadians agovernment-run HealthCanada, It’sand innovation. hometo also the way leads for research Ottawa world’s top fi forve sites R&D. communities andoneofthe one ofthe world’s intelligent most Intelligent Community Forum as consistently bythe selected been has Ottawa-Gatineau regenerative medicine. and immunotherapeutics, proteomics, strengths ingenomics, and demonstrating world-class conducting stem cell research center. Institutions here are andmanufacturing research, R&D, isathriving Ottawa clinical companies. technology advanced ishometo moreOttawa than 1800 than any other cityinCanada, capita and PhD per graduates With scientists more engineers, Ottawa: GlobalTechnology Center ne restaurants, golatene restaurants, night ective ective

66 NORTH AMERICA

8th Annual Canadian Meeting: Fostering Innovation GLOBAL FORUM F drug development and access. development drug to improve innovative processes, approval andfederal provincial efficiency, andstreamline on ways to improve trial clinical focus will this meeting challenges, andconfidentiality privacy new presenting while simultaneously stakeholders to share information andregulatory industry for opportunities increased that have dynamics market (#10019). Inthe context ofglobal Innovation &Access toDrugs Fostering Meeting: Canadian convenes for DIA’s 8thAnnual communitybiopharmaceutical as the internationalas Ontario, toreturn Ottawa, rom November 3-5, DIA will 3-5,DIA rom November Access and regulatory. 4will November reimbursement, development, clinical parallel tracks: along three thereafter proceed will meeting TheInstitutes ofHealth Research. Canadian Network, Effectiveness Director,Executive and Safety Drug Peterson,G. MD, PhD, MPH, & Young;Ernst andRobert Leader,Canadian Sciences, Life andPaul Partner Karamanoukian, speakers: bytwokeynote followed 4, onNovember the meeting open deliver welcomingwill to remarks Paul Director PomerantzExecutive WorldwideReimbursement. DIA on aPrimer and Detection two optionaltutorialsonSignal Wednesday 3with November on begin will The meeting Health Products Directorate. Health Products Turner, Marketed General, Director Directorate; andDr.Products Chris Th General, Director Directorate; Dr. Sharma, Supriya Th &Generic Biologics Dr. Griﬃ Elwyn &Food BranchInspectorate; Products Health General, Director Dowthwaite, Directorate; Diana Health Products Natural General, Director Boudreau, to include:Michelle currently planned &Food Branch, Health Products Health from Canada’samong leaders “Ask the panel discussion Regulators” culminate aninteractive with will DIA’s 8thAnnual Meeting Canadian session. featurealso aprofessional poster ths, ths, Director General, erapeutic erapeutic erapies erapies NORTH AMERICA 67

GLOBAL FORUM GLOBAL ciency in drug in ciency ■ , please visit our special For more information about information more For Canadian 8th Annual DIA’s Meeting meeting http:// mini-website at www.diahome.org/DIAHome/ FlagshipMeetings/Home. aspx?meetingid=23405. Kimby BartonKaren Kimby and (not pictured) serveFeltmate as co-chairpersons of the Canadian Meeting. 8th Annual right from clinical trials through from clinicalright trials through pharmacovigilance. the Given increased focus individualized on medicine, it willto be interesting see how these two fields align, as patient-specific more arguably the research becomes,that more the need a similar you may have to in your clinical patient-population with trials. also wonder, One might productsso many falling off the cliff”“patent near in the future, if we’ll see research more into going diseases, area of rare the rather same focus the than on so-called “blockbuster drugs.” lossGiven the of revenue impact that innovative industrythe will feel, R&D dollars will bescarce and will drive effi more demand for trydevelopment – to satisfy to as many with as few and payors regulators studies as will possible. be It interesting seeto how some traditional of the requirements” evolve data “must-have alignto jurisdictions with other in new to access provide patient to order medicines. Looking forward: hot What topics can participants look forward two to exploring or even three Annual Canadian Meetings from now? future, we willIn the see more focusand more area of in the individualized medicine and pharmacogenomics. In addition, opening the up of through clinical developing for nations trial research, increased and the to global regulators for pressures resources,share we can anticipate focusgreater on harmonization and globalization of drug development, trials, pharmacovigilance, regulatory the and updates to we focus year, This context. on innovations in clinical development, trend the including towards globalization and the personalized that role medicines in clinicalwill trials. have This links closely to the track that on reimbursement, we have presentations which will have look harmonization at that of trial the requirements for Canadian and provincial regulator formularies. In addition, there will be a focus on utilization of reviewforeign in information which Canadianthe context, again links globalization the to has already discussions.There been a great deal of interest tutorial, reimbursement in the are as companies many struggling with strategies meet to requirements of both federal and drug for provincial regulators we still ensure approvals. To for materials have in those with an interest pharmacovigilance, there tutorial will be an excellent on early detection of drug safety signals. c c ere are are ere suggest is is not to that This is the eighth offering Looking back, are some what of the changes, and how has of DIA’s Annual Meeting in of DIA’s only meeting is is the in Canada Last year’s meeting was Last meeting was year’s and focused on clinical excellent this eighth meeting evolved, from the seventh Canadian Annual Meeting presented last year? content. Th content. Th industrywhere and regulatory hear to get chance professionals the about specifi developments are that is limited Canadaall information to only; often are presentations there from and industry regulators in other jurisdictions give who invaluable overseas. is going on updates on what e meeting also provides a valuable Th opportunity networking, for the industry for chance to and regulators ideas and perspectivesexchange on productCanada. in approvals Canada. about What this meeting makes it so valuable to industry and regulatory professionals in Canada? Th Canadian the context. to meetings international many that on changes provide to information in Europe regulatorythe context provide US, and the but none that kindthis of Canadian-specifi Canadian Meeting Annual co- chairpersons Barton, Kimby MSc of Bureau Director, (Interim Allergy & Neurological Cardiology, Scienes, Products Therapeutic Canada), Health and Directorate, President, (Vice Feltmate Karen Regulatory Affairs, Quality Assurance & Business Services, AstraZeneca Canada, Inc.) shared evolution about thoughts the their of this future and potential Canadian Meeting Annual in the following pdates on the legislative Th is session was introduced by Jean Temeck elaborated the contexts and regulatory co-chairs Dianne Murphy, MD, and objectives of this FDA/EMA U processes for pediatric Agnès Saint-Raymond, MD, who collaboration: To avoid exposing drug development in the EU and respectively serve as the US and children to unnecessary trials US were delivered during two of EU representatives for the WHO’s by eliminating duplication and several Annual Meeting sessions Pediatric Regulators Network & ensuring that pediatric trials address devoted to better serving the Essential Medicines for Children unanswered scientifi c questions, and pediatric population. activities. “We’re going to talk a lot to enhance the science and decrease about collaboration,” said Agnès. the risk to children during pediatric FDA & European Medicines Agency product development by asking Update on Pediatric Legislation “We know that everyone wants us valid scientifi c questions and sharing (session 266) summarized to do something diff erent,” Dianne safety information. She quickly pediatric issues commonly good-naturedly noted. pointed out that this does NOT discussed between regulatory mean that FDA and EMA will arrive agencies in the EU and US, and Dianne and Agnès summarized at the same regulatory decisions. the collaborative nature of these the organizational and regulatory discussions and related initiatives. process diff erences for pediatric Jean then surveyed several recent drugs between the US and EU: FDA/EMA pediatric initiatives, Session #266 co-chairs: In the US, sections 4 and 5 of detailing examples and outcomes the FDAAA of 2007 established of specifi c discussions on pediatric Dianne Murphy, MD, the Pediatric Internal Review hypertension, pediatric HIV, Director, Offi ce of Pediatric Committee (PeRC) to provide adolescent migraines, and more. Th erapeutics, Offi ce of the high-level oversight of submissions “Th e FDA and EMA collaboration is Commissioner, FDA under the Best Pharmaceuticals very important in providing a robust for Children Act (BPCA) and the ethical and scientifi c framework for Agnès Saint-Raymond, MD, Pediatric Research Equity Act pediatric studies,” Jean concluded. Head of Human Medicines (PREA); similarly, the Offi ce of “In two years, this collaboration Special Areas, European Pediatric Th erapeutics is legislatively has proven to be very successful in Medicines Agency mandated to contribute to FDA’s identifying and addressing important Session #266 speakers / review of everything related to safety, scientifi c, and ethical issues.” pediatrics, although the 17 technical panelists: review divisions actually perform Agnès shifted the session’s focus by the reviews. In the EU, the Pediatric summarizing several impacts of the Jean Temeck, MD, Committee (PDCO) functions Paediatric Regulation in Europe since Lead Medical Offi cer, Offi ce of within the Committee for Medicinal its 2007 release. Th ese include the Pediatric Th erapeutics, OC, FDA Products for Human Use. Th e creation of: Junko Sato, PhD, PeRC makes recommendations; the Director for Risk Management, PDCO makes binding decisions. • New formulation, nonclinical, Offi ce of Safety II, Pharmaceuticals Dianne also described the monthly and extrapolation expert working

NORTH AMERICA NORTH & Medical Devices Agency teleconferences between the PeRC groups within the Paediatric (PMDA), Japan and PDCO, “the pediatric cluster.” Committee 68 GLOBAL FORUM • A new collaborative European Session #383 chair: internal committee that does Network of Paediatric Research not interact directly with study at EMA (EnprEMA) – “a network Lisa L. Mathis, MD, sponsors, who communicate with of networks” – that links to Associate Director, Pediatric & the appropriate review division international pediatric partners Maternal Health Staff (PMHS), instead. primarily but not exclusively in OND, CDER the EU “What I want to do is look at the PerC Session #383 speakers / and its interaction with the divisions,” • Th e Pediatric Medicines panelists: said Melissa Tassinari. “PerC has Regulatory Network (PmRN), its mandate after submission to under WHO auspices, which fi rst Hari Cheryl Sachs, MD, FDA and prior to its action.” She met this past February Lead Medical Offi cer, PMHS, explained the dividends – such as OND, CDER process improvements and metrics, “This is an active, interactive, and consistent review of products Rosemary M. Addy, MS, positive collaboration between intended for multiple indications Project Management Team Leader, international partners, which is that cross review division lines – PMHS, OND, CDER quite an achievement because that PerC provides to the review this is a global issue,” Agnès Melissa S. Tassinari, PhD, DABT, divisions. “Success in our mind is concluded. Last December, Japan’s Senior Staff Fellow, PMHS, good pediatric use that’s going to fi nd PMDA began participating, as OND, CDER its way onto the label,” Melissa said. an observer, in these FDA/EMA Chin Koerner, “PerC has added pediatric expertise collaborations. Executive Director, Regulatory and focus for both PREA and BPCA Policy, Novartis Pharmaceuticals pediatric programs.” Th e panel session Behind the Curtain Corporation with the Pediatric Review Committee Hari Sachs shared her perspective (session 383), composed of actual on the objectives of pediatric PeRC members plus a pediatric structure of FDA, and how the assessments and how to develop a expert industry representative, committee functions relative to pediatric program, including study provided insight to how the PeRC BPCA and PREA. PerC consists timing and design considerations, operates reaches decisions and of members from the Offi ce of which complies with PREA and recommendations. Chief Council (OCC), the Offi ce of BPCA. “We consider the types of Pediatric Th erapeutics (OPT), plus studies required to satisfy both In her introduction, session chair members from CDER and CBER regulations to be quite similar,” she Lisa Mathis reminded attendees who have expertise in pediatrics, explained. She also shared a list of that the PerC operates in the biopharmacology, statistics, critical questions that the committee context of FDAAA 2007 Articles chemistry, legal issues, pediatric asks when reviewing pediatric 4 and 5. “We thought it would be ethics and other appropriate areas. study plans, turned her focus to a real good idea to provide some PerC is mandated by law to review pediatric specifi c safety concerns insight into this committee,” she applications, written requests, and protections, such as Data Safety explained. pediatric assessments, pediatric Monitoring Boards, and concluded plans, waivers, and deferrals, by explaining how to submit a Rosemary Addy illustrated submitted to these centers through written request for a pediatric study where PerC fi ts into the pediatric BPCA and PREA. PerC is an deferral or waiver. ■ NORTH AMERICA

Several upcoming DIA educational oﬀ erings will further explore pediatric drug development in Europe and the US. DIA Europe and the European Forum for Good Clinical Practice will collaboratively present our Joint EFGCP Children’s Medicines Working Party 6th Annual Conference & 4th DIA Paediatric Forum: Current & Future Perspectives for Paediatric Medicines – Vision, Daily Challenges, and Ways Forward, 28–29 September in London, UK (#10118). Advancing Pediatric Research in the US (#10027), October 12–13, will be co-presented with our Maternal & Pediatric Drug Safety Symposium (#10032), October 13–14, in Bethesda, MD. Special three-day pricing is available if you wish to attend both meetings.

GLOBAL FORUM 69 M. Renee Simar, PhD (Principal Strategist, Pediatrics, INC Research) is serving on the program committee for Advancing Pediatric Research in the US and shared her thoughts on this program with the Global Forum.

Could you overview some in each region started much earlier. – PIPs – are required at the end of aspects of the industry and US legislation as far back as 1979 Phase 1 (EOP1) in EU compared to legislative contexts in which this called for pediatric use information, FDA expectations for plans at the meeting takes place? and pediatric working groups were end of Phase 2. Th e PIP timeline established in the EU 15 years ago. has reshaped the approach to drug Industry has undergone an extensive Reviewing our pediatric legacy development in many companies. pediatric learning curve in the US and evaluating ongoing challenges Oftentimes, at EOP1 in adults, and, more recently, the EU. Our during this meeting will enable information on the compound is program committee designed sessions us to continue our progress as an limited to basic pharmacokinetic on the essentials for successful international pediatric community. data; at that juncture, the fi nal pediatric programs, focused on indication may not yet be determined regulatory and clinical activities to Attendees will have opportunities for adults, much less for children. highlight the critical importance to interact with speakers through of coordinating these two areas panel discussions. We are especially My understanding is that the EMA’s in the earliest stages of program looking forward to collecting attendee objective for early planning was development. Th e unique challenges responses to specifi c questions; somewhat prompted by perceived lags of pediatrics demand an integrated their feedback will encourage post in US pediatric programs. Regulators approach. Why? Because clinical conference “homework.” Ideally, remind us that pediatrics is time- feasibility may become a roadblock the outcome of the conference will consuming; thus, the mantra for child if regulatory strategy is developed be increased pediatric papers in medicines is, “early planning, early without thorough consideration for the Drug Information Journal and planning.” Th e EU legislation was study execution in pediatric patients. articles in the Global Forum. Ongoing designed to inquire, sooner rather Simply stated, “If momma isn’t happy, analysis of the process and content than later, “Applicant, what is your no one’s happy.” In other words, we of pediatric programs is important to plan for children with this product?” “begin with the end in mind” by minimize the risk of failure and ensure Th at impetus has prompted drug considering how families will view favorable outcomes for child health. developers to consider all elements of individual studies. Th eir perspective the pediatric program in parallel with can be a useful guide for program What lessons can clinical and initial stages of the adult program. design and regulatory strategy. regulatory professionals in Th is means, for example, considering the US learn from implementation all age groups, not just adolescents Our committee considered the of the EU Paediatric Legislation? who may be easier to enroll. EMA increasing importance of global asks applicants to evaluate at the pediatric strategies by evaluating both A key diff erence between the legislation outset of a program if product use will US and EU regulatory experience. in the EU and the US is that the EMA extend to neonates. If a wide range of

NORTH AMERICA NORTH I mentioned experience from the expects early engagement on pediatric ages, will you need to study multiple past decade, but the groundwork plans. Paediatric Investigation Plans formulations and dosages? 70 GLOBAL FORUM NORTH AMERICA 71

ort to to ort GLOBAL FORUM GLOBAL D Ph ■ i S R M M. Renee Simar, PhD M. Renee Simar, sometimes by assent confounded forms developedand consent to satisfy ethics multiple committees a single trial.for One solutionis discuss simply to requirements with prospective in committees advance of submission. Investigators versed well generally are the in localdemands of their ethics committees and can guide project teams accordingly. with experience pediatricMy a fundamentalclinical teams is that question often stymies initial their my planning: “I would not enroll own – how can child I support and e premise is design Th study?” this but it needsunderstandable, be to not a stumbling for, a foundation block a reasonable to, approach. can legacy build on the of Teams pediatric product development readily availableby examining postedinformation and FDA on the EMA sites, web clinical trial reports on industry sites, web manuscripts, and, participating by actively of course, in Navigating our conference. clinical challenges requires issues and workinganticipating closely with on design stakeholders Issues study. the prior executing to can be by analyzing anticipated similar studies, socommittee our planning included a session on recurring issues in clinical implementation. look forward voicing attendees to We owntheir experiences in an eff identify collective solutions with our panelists. c cally e number e overriding e ethical quandary for onsideration of the individual the of onsideration participantspediatric – patients –when we design pediatric programs clinicaland conduct trials. Th pediatric clinical means teams is the to of researchminimize burden for the parents: and their children do “How we decrease number and duration the of procedures, lessen pain and discomfort, and reduce psychological distress, while ensuring scientifi do we explainsound studies? How research to a child and their caregiver?” the dilemma are the to Adding in perspectiveerences of diff and ethics committees regulators on trial design and risk. Regulators requestmay or recommend specifi of assessments of blood or amount allowed ethics may by the committee not align view. regulators’ with the issues Other include the common means obtaining for agreement to participate. Agreement participate to in pediatric both trials requires that well-informed,child and parents are so-calledthe “pediatric dyad” of e meansto assent and consent. Th they understand is that this ensure among pediatrican ongoing debate stakeholders. teams are Pediatric designs or procedures, whereas ethics primarilycommittees are responsible decidingfor procedures if the meet criteria allowable risk pediatric for to participants. are Complexities pediatriccompounded by multisite ethicsstudies involving committees countries. across many An example perspectiveserent are diff where group. evident of control is choice has historicallyPlacebo been the trials, for gold standard but this is especiallypractice in questionable pediatrics patients we study where volunteers.instead of healthy Clinical teams often face managing regulatory placebo for requirements despite opposition ethics from their recurring Another committee. issue is laboratory assessmentsendpoints for and safety monitoring. Th c e e erent than erent c questions, c e recent shift to rst day of our conference. our conference. of rst day rst years US pediatric of the What ethicalWhat issues do pediatric clinical research the burden of the research should be equitable, and harm should be pediatric minimized. However, clinical obligated teams to are bar” the with “raise in accordance guidance on research in vulnerable populations. it explain to One way our moral compass rightfully is that becomes more directed to the Many issues no diff are Many teams commonly face, and how do they typically navigate through or respond to them? for adult studies — the research should answer scientifi Delaying pediatricDelaying discussions until meetings waspre-NDA norm the fi in the requirements. Th earlier planning is partially the due to of EMAuence requirements. Th infl Despite challenges new the of this paradigm, most observers agree that a positive changes having the are impact on pediatric medicines. Th US clinical teams can also adapt example, For lessons EU. from the allowable reimbursement, advertising, recruitment and other tactics cases, in many are, stricter EU than in the comparatively US,the but these can limitations be of by early engagement overcome on clinical feasibilityinvestigators for e mantra and enrollment. Th for than erent clinical is no diff regulatory: Early planning. value of earlier discussions with FDA value discussions with FDA of earlier is gradually being in the accepted US, challenges. despite its inherent infrastructure example, has For been revamped companies in many support FDA to plans for parallel and EMA. Strategies global for pediatric will planning be discussed fi on the US regulatorylesson for professionals pediatricsis that can and should product overall be integrated into a development to and not relegated postapproval exercise. 72 EUROPE

GLOBAL FORUM Lisbon Th delivery. trial ofclinical approaches to allaspects studiesandpractical case leading-edge presentations that provide will selected Future the committee programme has In adoptingthe theme, Navigatingthe trials. ofqualitycompliant clinical aspects ofall implementation, anddelivery design, to enable faster and technologies processes trends, challenge the newest and about to learn the opportunity Th Portugal. in Lisbon, readers. conferenceupcoming for Global Forum insight into provided the Chairperson, Julianne Hull (Pfi is available until 27August. discount Anearly-bird 2010 andbeyond. through development navigating clinical that stimulateevent on will discussion now for this exciting,cross-functional areto encouraged register Delegates themes. to debate all addvalue will plenary specifi available. Th be will c learning Tutorials to support andworkshops hallmark-“build conference.” yourown to Forum’s theand leading Clinical disciplines, the across varied sessions off themes, ofmultiple themed method and-tested T challenge the newest trends, processes, processes, trends, challenge the newest and about to learn the opportunity This 4th Annual Forum Clinical offers is multidisciplinary conference off ismultidisciplinary econference adoptthe tried- will the 4th Annual Clinical Forum? Clinical the 4thAnnual of ofthefeatures What aresome planned for 11–13 October 2010, for 11–13October planned Forum NavigatingtheFuture is Clinical he 4th Annual DIA ering attendees achoice of attendees ering zer, UK),Programme e ers EUROPE 73

is GLOBAL FORUM GLOBAL ■ What other highlightsWhat will be featured the 4th Annual at Believes is House Increasing that Julianne Hull Julianne Clinical Forum? DIA Annual 4th is the This European Medical Information conference and Communications This Clinicalwithin the Forum. firstis also the Clinical Forum incorporate severalto sessions specifically on Clinical Endpoints. also includes someThis discussion clinical monitoring for on adaptive trials. attend e one session all where Th plenaryis the Th session debate. year’s topic should excite interest interest should excite topic year’s across all disciplines current in the environment:budget-challenged Th of Bureaucracy Future Is Killing the Clinical Trials Networking opportunities will be main exhibition in the available will attendees hall, where have opportunity with the interact to colleagues, friends, and service providers. Navigating the Future is a not-to-be-missed experience all clinicalfor operations professions. marketing studies willmarketing be addressed in several themes. What are this year’s hot are thisWhat year’s topics? inical research? Social networking, social media, and how they can be used in clinical networks topics are interest. CDISC exciting and Clinical Data have Standards been discussed times; many now standards are however, broadly being more implemented clinical not just for data and are willmanagement. be There seekingpresentations elaborate to on clinical – from standards final reporting. through protocol Quality and achieving right the – we will quality is an essential severalhave seeking presentations bestthe strategies, processes, and technologies delivery ensure to quality in the data right of the Data and warehousing eWorld. regulatorythe for considerations leading archiving are site/data topics. will be There several on methods presentations of clinicalresourcing for trials and pitfalls.their Complementary to these discussions are on achieving inspectionsustainable readiness also pushing in an environment The enhanced for productivity. needs of observational and post- to the advancement of global cl Flexibility of approach is a key of approach Flexibility operational professionals. for mantra option a multiple-choice Having enables attendees presentations for chooseto is most relevant what for them. and workshops also Tutorials offer opportunities an in- for of specificdepth study topics. Networking receptions enable cross-fertilization of discussion own discipline, within one’s and also with those from other functions. ers a a ers e Navigating Navigating Why isWhy the structure of the Clinical so Forum important Th e Clinical Forum e Clinical is a Th multidisciplinary event. Can ecting these various interests, attendees have the choice of of choice the have attendees hearing, meeting, and challenging those own in their discipline and sessions outsidealso attending of broaden their to usual sphere their horizons. Clinical Forum refl ects many the refl Clinical Forum facets of clinical research – whether from pharma, biotech, academia,CROs, clinical trials sites or elsewhere - and off varietybroad of cross-industry and discipline is very presenters. It bring to a plethora together exciting including Clinical of professionals Data Management/eClinical, Clinical Operations, Clinical Research, and Post-Approval Peri- Studies, Drug Safety and Risk Management, Quality Assurance, Clinical Endpoints, eTechnology Medical and Validation, and Communications,Information themed sessions With and more. refl One size does not fi Th t all! One size does not fi you explain thisyou explain dynamic? and is geared help to the Future clinical operations professionals strategically think regarding the development and implementation processes and right of the technologies work their for environment. and technologies faster enable to and design, implementation, delivery of all aspects of quality- clinical trials. compliant As requested previous at meetings, will presentations of the many be case real-life studies offering opportunity the attendees to discuss reality of new the process/ technology in implementation The a regulated environment. is entitled conference 74 EUROPE Meetings in Upcoming November 2010 Orphan Medicinal Products. Medicinal Orphan for direction andfuture landscape • • • TopicsKey 3 November inEuropeDrugs The DIAFuture DirectionforOrphan D

designation? What oforphan isthe value andIncentives: Rewards Orphan exclusivity, andother challenges benefi similarity,t, market Signifi Drugs: Orphan Marketing Authorisation for in the course ofthe first 10years? changed andwhat has we learned What have Designation: Orphan GLOBAL FORUM Paris to exploreParis the HTA European stakeholders in invites youtoall join IA cant in Europe. Opportunities Opportunities in Europe. products medicinal to share of development with experiences and regulators industry, researchers, academia, orphan together patients, is to bring the Th eaimof thisone-day conference shared. be also will Products Medicinal celebration conference onOrphan 10-year Agency European Medicines andoutcomes the from Learning onfuturedevelopments. outlook an andprovide regulation Products Medicinal of the European Orphan inthe fiexperience gained rst 10years Th e conference will reflect on the • opportunities for orphan drugs for orphan opportunities and challenges Particular AccessMarket andHTA: • • • • TopicsKey 4-5 November Treatment toEuropean Patients Building System togetEff anew Assessment (HTA) Conference 2nd DIAHealthTechnology orphan medicinal products medicinal orphan to marketaccess designation from of aspects various while addressing discussed be will and challenges Right Data to the Generate Methodologies Conditional Reimbursement and Schemes Risk-sharing Schemes PatientInnovative Access Europe Mapping the HTA in Landscape HTA Orphan Drugs ective ective EUROPE 75

■ GLOBAL FORUM GLOBAL authorities to the European European the to authorities Medicines Agency in London and payers and from industry, beneficiary ultimate – the of a successfully functioning system – benefit patients who stand to the fruitsfrom the of innovative objective The move is to R&D. from “What is happening?” to will ‘what’ “How we make this a functioninginto reality that achieves different multiple the objectives from involved all stakeholders?” nments or payers, working are Delegates are encouraged to register for both conferences to take to advantage Delegates encouraged register both to are for conferences sessionsof valuable crossover and a special discount. 1 Day Attend 1.5 Days Attend 3 November Orphan Drugs €850.00 for 2.5 Days Attend or 4-5 November HTA DIA Contact more the for in Europe VAT. to applicable are All rates 61 225 51 51 or email [email protected]. +41 information €1350.00 for 3-5 November Orphan & HTA €1100.00 for 3-4 November Orphan Drugs & HTA NEW! Credits Swiss e the and AssociationPharmaceutical of (SwAPP) Professionals Th SocietySwiss Pharmaceutical accredited for Medicine HTA the have (SGPM) with 9 and Orphan Drugs with 6 credits. Conferences in the countries,in the whether they are gover to understand how to evaluate understand to to how they payingwhether what for are is beingis worth price tag that the countries asked. And, increasingly, a create to working together are assessment HTA coordinated more model. will bring conference This – all stakeholders together governments,from to regulators competent from national t Management Management t Building “Beneﬁ Plans” getBuilding a New to System EU to ective Treatments Eﬀ Patients • • Technology Health The landscape in Assessment (HTA) under the is currently Europe ever than more spotlight before. is changing,It evolving, and is in an increasingly dynamic of state flux, as agencies and globally here try pathway figure right to out the right the forwardthat ensure to to made available are treatments healthpatients in sustainable care frameworks. therefore, is also increasingly, HTA becoming focus the of the involvedstakeholders in all stages medicinesof the development process. proactively are Patients engaging with evaluators and payers. Innovative medicines manufacturers build understanding working to are value productsof the of their – not patients,only value the to but also health care systems the to and to society as a whole. Decision makers DIA/EFGCP Workshop on Monika Pietrek odern technologies support PV Audits and Inspections the increasingly complex M day-to-day activities related to pharmacovigilance. Global drug Sharing Experience and Strengthening safety monitoring and risk minimization are essential to avoid unnecessary harm to patients. While of Mutual Understanding drug safety science crosses functional and geographical borders, most of the relevant legislation is still territorial. Even within the EU, the implementation of the applicable directives into national law and their interpretation vary among EU Member States.

Th ese diff erences are also refl ected in the inspection experience of pharmaceutical companies and their partners. Th e scope and approach of PV audits and inspections show a large variability; in addition, observed fi ndings may be rated diff erently during PV inspections. Diversity of fi ndings itself is not unexpected; however, it may create some confusion and ultimately adversely aff ect the prioritization of corrective actions undertaken by the Marketing Authorization Holder and their partners. In particular, the transition to the new pharmaceutical legislation, the increasing number of patient support programs and changing patterns of safety reporting due to the Internet may present challenges to existing PV quality management systems.

Th e regulatory authorities have undertaken considerable eﬀ orts for coordination by formally establishing the Pharmacovigilance Inspection Working Group and generation of the Pharmacovigilance Inspection Policy for Centralised Procedures- Medicinal Products for Human Use in 2009. Th ese eﬀ orts have certainly contributed to an increased exchange among the national authorities and the EMA PV inspectors. However, there is no mechanism for information exchange on PV inspections between the inspectors and industry, ethics

EUROPE committees and investigational sites/ academia. 76 GLOBAL FORUM EUROPE 77

GLOBAL FORUM GLOBAL ce, Postfach, 4002 4002 Postfach, ce, Save the Date 1 October 2010 CanaryDE VERE Wharf, Venues, London, UK Monika M. Pietrek,Monika is MD, Pietrek Associates Director, Managing Programme Germany and GmbH, of thisCo-chair workshop. Pharmaceutical Medicine have(SGPM) workshop credits. with 5 accredited this Register To Please DIA the contact customer +41 61 225 51 at Services Team can also register www. at 51. You diahome.org/pharmacovigilance2010 by fax +41 61 225 51 52, email: [email protected], or mail: DIA Offi European Basel, ■ Switzerland. rst one of its ers a unique great erent viewpoints, erent stakeholders.erent DIA PV interactive is one-day, Association e Swiss of Credits Th Pharmaceutical Professionals Society Swiss and the (SwAPP) for workshop fi is the understanding mutual and enhance diff of the and EFGCP acknowledgethe dedicated of the commitment representatives of EMA and the agencies.national topics of the grouptopics sessions the of and also panel submit questions the to for discussion. Overall, workshop the is designed exchange the encourage to mutual and foster of experience challengesunderstanding the for involved. drug welcome like to would We scientists,safety physicians, pharmacists, process analysts and process engineers, software designers, quality/compliance managers, auditors, inspectors, trainers, investigators, representatives from ethics committees and regional/local authorities, academic and large workshop. the to institutions Th kind and off opportunity to share experiences, discuss diff e e t to those e Drug safety monitoring PV systems/oversight PV quality management PV audits and inspections DIA erefore, EFGCP and in Th e workshop program will provide Th discussion for a neutral platform parties.erent Th between diff the of plenarycombination and breakout sessions will a great allow deal of of a variety and coverage interaction of hot topics. DIA and EFGCP establishedhave a mechanism that select to enables attendees the at pharmaceuticalat biotechnology and companies, regulatory agencies, ethics committees, CROs, and sites.investigational responsible for • • • • Th withinspection collaboration have designed workshop a one-day of PV experience the share to audits and inspections. Th designinteractive will provide a unique opportunity PV the for and PVpharmaceutical community and inspectorsauditors discuss to their experiences since and exchange of PV inception the inspections. Th workshop will bring benefi 78 EUROPE

GLOBAL FORUM hot topics, and special sessions. and special hot topics, forum, inadditionto aGCP leaders, theme byexpert led 15 themes feature EuroMeeting 2011will UK, MHRA, Management ofMedicines, Director,Raine, ofRisk Division Switzerland, andJuneCorporation, Valdo Manager, General Anera, PHT Convention Centre. by Chaired Switzerland, at the Palexpo cityofGeneva, beautiful T March 30. on Hall Meeting Wednesday,Town at 2011- theEuroMeeting New Under Development EuroMeeting 2011 28–30 March 2011inthe place take will EuroMeeting he 23rd Annual Geneva to Host • • • • • • • • • • • • • • Management andTelematics: Th Vaccines Th and eme13Biologicals Worldin the Real Th disappear? to Isitabout Boundary: Th Drug/Device eme11 and Counterfeiting Quality and Assessment, Th Inspection CMC, eme10 Th eme9 Pharma e-World Populations for Special Medicines ThDeveloping eme8 Lifecycle Drug ThStatistics across the eme7 and Development Research World!Research Pre-Clinical Th (Generics/Switching) Th eme5 Wider Access Eff and HTA/CostEndpoints Th Study eme4Clinical Minimisation AnalysisandRisk Risk Integration to Benefi From and Collection Data Th Environmentin aChanging Th Medicine Personalised Future ofTreatment eme 1Innovation, and Th eme 12 Drug Development Development eme12Drug eme 14 Knowledge eme14Knowledge eme 6 Engaging the eme6Engaging eme 3 Patient Safety: eme3Patient Safety: Approvals eme2Securing ectiveness t/ January 29! January onorbefore registering by rate theearly-bird €150with Save andhowtothere. get city ofGeneva morethe about andlearn hotel rates, negotated ofspecially advantage take professionals activities, more student about andyoung anexhibitor,on being fi information get for the meeting, register programme, the preliminary You able to be download also will EuroMeeting icon for information. diahome.org andclickonthe professional poster. to www. Go to submita but itisstillpossible Th isnowclosed, Call forAbstracts e c. c. b. a. Geneva which European city? London in is headquartered (WHO) Paris Th achancewith to win: in tothe be question following to the 17with answer September by [email protected] nextvisit year. Simply email companion for yourEuroMeeting itisthe perfect and drinking, eating, sightseeing, shopping, in best which pinpoint the very illustratedwith full-color pages Featuring clear, accessible maps away. to give book guide CitySpots We have four copies ofthe Geneva Win Book! Guide aGeneva eWorld Health Organization • Boundaries/Partnerships Th eme15 Working Across decision-making for their improving support andregulators and industry Enhancing exchange between ■ nd out JAPAN 79

omas erent erent GLOBAL FORUM GLOBAL airs Division, airs What do you hopeWhat attendees will learn from the discussion and “Providing Meaningful Safety detection showing that Information,” les from diff of safety profi viewpoints in this is also essential discussion Active is also activity. and Situation expected “Current at Challenges in Clinical Research,” activities the presenting of drug discovery and clinical research at and seekingacademic sites in Japan, them. promote to ways on “Expectations for the Role of Asia and Japan”? is important session is scheduled Th afternoon late in the second of the Murray meeting. of the day Dr. Th FDA,Lumpkin, and Dr. Lönngren, EMA, kindly have our requestaccepted join to in this participationthe meeting. of With PMDA, Kondo, we’ll Tatsuya Dr. be discuss to able expectations and and Asia in drug roles of Japan the development with key regulators We and Japan. US,from the EU, to Kurokawa Tatsuo askedhave Dr. Program Co-chairperson, Masaru Iwasaki, President, PhD, Vice MD, Aff Development Medical and GlaxoSmithKline K.K., answered a few Japan questions readers for Global Forum the about 7th DIA Meeting, upcoming Annual Japan October 28-29, 2010. ect- er attendees er Th e two keynote addresses, Th one on developing products erent points of view on drug

ese keynote speeches will be drug identify development and to the future. Another the for value Japan of year this willtopic be pediatric drug development, which needs more orts be to globalized. in Japan eff development in and globally. Japan are theseHow two themes refl ed in the meeting tracks? Th presented most by two of the leading uential Japanese infl physicians. addresses, In their they expected are encourage to more toward audience the in newactive drug involvement themes e presented development. Th will be followed by “Meaning Global an Early Stage at and Clinical Trials where Consideration,” for a Matter needthe and entrepreneurship for valuethe of ethnic evaluation at an earlier stage will be discussed, diff that originatethat in and the Japan, role in global drug other on Japan’s development, will off

Th is is the 7th Annual DIA Th Japan Meeting. Can you

Interview with Interview

Iwasaki Dr. Masaru More than 10 years have passed 10 years than have More of new implementation the since GCP ICH and the guidelines in During time period,Japan. that bridgingthe method utilize to the complete clinical to data Western package data Japanese was applied. newNow that drug development in has becomeJapan globalized, more simultaneous submission and goal. Previous is the approval DIA meetings investigate to held were synchronize to with way the Japan global the method explore and to ective drug development eff the new in the process in Japan here these environment. Following and thinking about the topics so far, clear of globalization,recent trend DIAthe meeting year this will off please provide some perspective on how the 2010 meeting builds on the previous ones and also identify erings in this year’s the new off meeting? opportunities clarify to and role the new to of Japan contributions the

JAPAN 81

GLOBAL FORUM GLOBAL is team was safety evaluation team was formed the 2010 and explained in April in data of use of foreign content before and after E14 the Japan She emphasizedGuideline, that importancethe of cardiac safety in drug development was not only (TQT) QT result of thorough the but also risk/benefit the study in all clinical studies. Session 3: Foreign Experience in Foreign Session 3: QT of Drug-induced Evaluation Prolongation Risk (TQT) QT A number of thorough beenstudies have conducted in the 2005. In this since US and Europe session, and sponsors regulators US gave EU and the from the experiences their of presentations One of the with cardiac safety. Wang Yaning waspresenters Dr. US FDA, from the PhD us who gave introduced He his US experience. interdisciplinary QT FDA the Th (IRT). review Team established 2006 and has in June QT to approach had a consistent interval evaluation. Börje Darpö MD, of academia a representative PhD, Session 2: S7B and E14 Guidelines Session 2: and Q&A ICH S7B guideline, E14 guideline covered in and E14 Q&A were Kaori Shinagawa session.this Dr. (Pharmaceuticals and Medical Devices Agency[PMDA]) of the presented contents the E14 guideline why and explained these not been guidelines have from 2005 in Japan implemented showed Octoberto 2009. PMDA evaluationthe prolongation of QT risk (nonclinical and clinical data from NDA in Japanese data) QT 31, 2009, August 2005 through of the implementation before the She noted E14 guideline in Japan. cardiovascular PMDA the that E14 guideline, a number of E14 guideline, a number of by representatives presentations from US and EU sponsors and FDA, from the regulators the Canada, provided Japan and EU, of new amount an impressive attendees. for information Comments on some individual sessions follow. and presentations mid growing concern mid growing concern about drug-induced potential, proarrhythmic

Maki Ito In this environment, the 1st DIA environment, the In this in Japan Cardiac Safety Workshop on Tokyo was in Funabashi, held 25–26. As mostMay companies conducting experience little have clinical studies underlying the the International Conference on on Conference International the Harmonization (ICH) has provided safety measures against cardiac ICH The S7B guidelines: safety. of the Non-Clinical Evaluation The Delayed Ventricular for Potential Repolarization Interval (QT by Human Prolongation) Pharmaceuticals and E14: Clinical Interval of QT/QTc Evaluation and Proarrhythmic Prolongation Non-Antiarrhythmic for Potential Drugs reached Step 4 in 2005 and US and in the implemented were the In Japan, same year. EU that the S7B guideline was in implemented October E14 2009, and the guideline will take effect in November 2010, even it is though now in a grace period. A 82 JAPAN

GLOBAL FORUM that conduct TQT will studies. informative for Japanese sponsors TQTwho conducted studieswere ofsponsors representatives from regulatorsand Health and Canada Th efrom US comments FDA, EU, relation to conducting aTQT study. ethnic diff in were discussed erences, QT, control, positive genderand study, concentration-QTc, correction interpretation ofthesuch as TQT held. Many issues was discussion around table session, In the last assessment. collaboration risk oncardiac for ground futureresearch fertile that suchinitiatives have a created and QTfor clinical assessment improved ourmethods/approaches have andacademia regulators, initiatives amongsponsors, that collaborativeHe emphasized in the EU, gave also apresentation. end oftime.We to meet hope debated tillthe be can products to safetyfor cardiac developing Many related issues attendees. a highnote more with than 150 Workshop inJapan on ended Th sessions. information between andexchanged shared attendees where anarea presenters and as Also,this fl visitors. to theirintroduced products to companies the mainhall.ECG Th located next was e exhibition area discussed. were Development” Clinical in Late Assessments Safety “Cardiovascular TQT Study inJapan,” and inConducting Issues “Practical Assessment,” QT Risk Nonclinical of andUsefulness “Predictability In the other sessions, e 1st DIA Cardiac Safety Safety Cardiac e1stDIA oor was used used was oor Maki Ito, MD, Ito, PhD,Maki ser next ■ year! safetyinthiscardiac meeting of issues together anddiscuss author [email protected]. LTD.& Co., the contact can Readers Shionogi Management Department, Medical Offi Advisers M ki I t MD Ph D ce, ce, Drug Safety ves as Head, Head, as ves H Sultan Ghani and Vinisha Bhavsar with Core Committee Members of the Young Professionals Chapter.

n May 26, a DIA Young Nirav Chokshi, provided an • Employable education for Professionals Chapter introduction about the new students O opened in Gujarat, under chapter. the guidance of Sultan Ghani • Platform for knowledge sharing (Director, DIA India) and The Inaugural Address was given for young professionals Nandkumar Chodankar by Mr. HG Koshia (Commissioner (Chairperson, Advisory Council of of FDCA, Gujarat), and Shrenik • Networking opportunities India). Th e opening ceremony took Shah (chapter vice-chair) gave a place at the Hotel Fortune Vote of Thanks. Approximately Proposals for upcoming events Landmark, Ahmedabad. 50 professionals associated with include the common technical the pharmaceutical industry, document, pharmacovigilance, Sultan Ghani delivered the academia, and regulatory agencies compliance and registration, Welcome Address, followed by were present to lend support to this quality by design, entering Africa- a video presentation about DIA initiative. compliance and commerce, entering and the ceremonial lighting of Europe-compliance and commerce, INDIA the lamp. Nandkumar Chodankar Th e new chapter is committed to and biosimilars. offered a presentation on DIA DIA’s mission and vision, and to and its activities in India and focus on three basic needs of the Monitor www.diahome.org for more worldwide. The chapter chair, local community: information. ■ GLOBAL FORUM 83 84 ON LOCATION: BANGALORE

GLOBAL FORUM B of Karnataka, Bangalore is situated halfway between the coasts in southern insouthern the coasts between is situated halfway Bangalore of Karnataka, fi isIndia’s Bangalore for 10,000 industries, andabase well over6millionpeople, Silicon Valley”, “Fashion ofIndia,” Capital and“Th ePubCityofIndia.” Home to “India’s says nicknames why: at of its some andalook isbooming, Bangalore the Siliconalongside Plateau ofIndia! itisabustlingcity, anddiverse in 1537—today that ancientfl with arts where diff the city founded Kempeerent Gowda exist. culturesandcustoms city the is weather city, isacosmopolitan Bangalore winters. summersandbearable pleasant The greenery and blossoms delicate Thdelicate and greenery. blossoms weather e is thecity’sfeature,best with for its Itthe “Garden iscalled City” Cit isthe ofKarnataka. capital Bangalore INTRODUCTIONI fth largest city and the fastest-growing city in Asia. Th largestfth cityandthe fastest-growing cityinAsia. NTRODUCTIO INDIA angalore N gr eene ry . h ete stecit is the weather The e capital ofthe ecapital state y ’ sbestfeature with y ” for its , ourish ourish with ON LOCATION: BANGALORE 85

ers e IT e ers a wide e city off GLOBAL FORUM GLOBAL nd yourself nd e city off several the ered at “idli” nd it in Bangalore. SHOPPING shopping,If you enjoy you will enjoy air-conditioned the Bangalore. From of super ambience like Shopper’s stores bustling the to Fort and Kemp Stop by-lanes of Chickpet, Bangalore er every kind has something off to fi could You of shopper. some biggestshopping for of the brands down while strolling world in the Brigade be Road, or you could engaged in friendly haggling with a shopkeeper silk sari somewherean exquisite for City Market.in the Whether you are looking Kancheepuram for silk or crystal,Swarovski you will are chances fi CUSINE Bangalore is a paradise those for who love good food. Th of cuisines,choice traditional from the can try but simple the You exotic. the to fare off excellent shops, bakeries. numerous and the a hearty meal, city is home to the For several restaurants serving anything Chinese to cuisine. from continental is more eating most people today, To a luxury. than of convenience a matter A wholesome, meal hygienic can be CULTURE rich heritage cultural Bangalore’s combined with its technological and industrial achievements has made it most “happening” cities. one of India’s Bangalorewitnessing is the Culturally, revival of traditional art form of in the drama,dance, and art. Almost every aspect of painting, weaving, pottery, hasor theater been restored and exists incredible an creating enjoy, us to for Th fusion new. and the old of the boom corporate activity and intense people attracted have from all over. Bangalore has become pot a melting cultures, many for giving it a rich Th cosmopolitan character. something everyone…recreation for areas, pubs, and magical nightlife, and big shopping malls,quick getaways thriving arts, entertainment and the has become It scene. style capital of the countrythe in a true sense. at rate rate at er you er cation number. number. cation country. It has a large bus terminus, has a large It country. station. which is near railway the All types of tourist buses easily are hire. on available GETTING AROUND Taxi e taxis in veryBangalore are Th Most and comfortable. convenient taxi will a fl companies charge license yellow generally have Taxis with black letters.plates Private Car Most taxi and auto-rickshaw drivers off will to be happy than more and rate, or an hourly a daily rate either take wherever you around you need to or a travel your hotel go. Alternately, can arrange a private car. company generally somethingRates are like Rs. 100 per 50 to an auto- hour for and Rs 150 to 250 per hour rickshaw, a taxi. for a private Rates car for booked will bevia probably hotel more. the of Rs 150 for a pick-up and drop and drop of Rs a pick-up 150 for from anywhere within anywhereto or return trips city limits. Waiting will be charged extra, as will a lot of heavy luggage. countries, other many taxisUnlike are signs on the not marked with “Taxi” cars Instead, the willtop. be marked eet or operator fl the logo of with the sides car. on the the of taxi company sign a yellow Some have companies numbercation on the with an identifi these Keep taxistop. in mind that cannot be hailed street, from the but be to calledhave When by telephone. you call, give you must operator the your location, and phone destination, the you e operator tell will Th number. you must inform you that (or charge meter) as asgo by the taxi well the e taxito pick you come will Th number. driverup, and the will call you when he is close. street, When you go out on the number the for plate license look the at they you—it will gave be last the four digits Alternatively, plate. license of the car the boardlook yellow atop the for identifi taxi’s with the ere ere Bangalore is connected by road with the throughout highways national are two railway stations in Bangalore. stations two railway are connected is well e main station to Th Indian cities.all major Bangalore is connected rest the to countryof the both by meter gauge rail services.and broad gauge Th BANGALORE TRAVEL INFO BANGALORE TRAVEL road, Bangalore by air, is accessible and rail. Bangalore Airport is 13 km east of the City Station. India. Many international visitorsIndia. international Many Bangalore to its for come excellent schools and universities, such as the of Science. While Indian Institute enjoying warm the year- weather touristsaround, can city also use the baseas trips other a central day to for Karnataka attractions. 86 ON LOCATION: BANGALORE

GLOBAL FORUM • • • or at the biggerhotels. inthe 24-hourcoff time isbest pubclosing outafter Eating midnight. until stay restaurants open Some 11:00 pm orders by10:30pm). (last at close Bars of therestaurants. star thousands at afew any spend you can pockets, orifyouhave deep Darshanis, 20/-at of astring little Rs. had for as as choices. family, off Bangalore of ers youahost your with resort at aswanky pool orjust relaxing bythe dancing, out, activity,outdoor eating pubhopping, whetheryouprefer doitall.So can you Jakkur inBangalore aerodrome, at the to parasailing in the country theaters ofthecomfort ofsome best inthe releases the latest Hollywood Fromunwind andrelax. watching offBangalore ofways to ers avariety ENTERTAINMENTLEISURE AND which can cause headaches. headaches. cause which can contain the additiveglycerol, may Note: Indianbeer people. twoorthree between sharing suitable for in 650mlbottles, sold ItBangalore. is typically in availableand widely beer Kingfi popular sher isthe most meal. overly spicy the an stomachcalming after eff very also refreshing onahotday andis isparticularly one.Lassi popular a mangobeing orfruit, sugar plainorfl is served It availablereadily inBangalore. is lassi drink yogurt-based the ofIndia, inmanyAs parts to quench the thirst. enjoyable, andinexpensive way straight the from nut isahealthy, andthe water sipped Bangalore, Fresh coconutsare abundant in ective in cooling and incooling ective avored with ee ee shops • • • experience. Tank off andSankey Lake Ulsoor Bangalore. Visit in lakes shops. thebeautiful the traditionalsouthIndian-styled in atSampige Road Malleswaram unique shoppingexperience on Enjoy thethe Palace Grounds. concert at outdoor a wonderful AttendTry yourhandat go-karting. Gandhibazaar. Road, Bazaar Gandhi found in more be lively onecan Asmallerbut Market. KR called ofthe city market isinthe heart city’s andfruit largest vegetable Central. Th Mall, andBangalore are Th Bangalore mallsin ofthe more popular Some fi overweekends. spot nd aparking it’s as your car to impossible almost butleave and traditionalmarkets, shopping at Banglore’s malls famous Go andChurch Road, Street. Brigade scene, around mostly MGRoad, pub the Bangalore Experience THINGS TO DO India, +91-080-4213-4915 India, 560102 Karnataka Bangalore, main, 1stsector, layout HSR 4th Floor, tours., eco 2628, 27th Th and Adventure rillophilia [email protected] Email: include breakfast/brunch. 500(approx $10.00)and Rs. 300(approx $6.00)to Rs. from Thof Bangalore. range walks e way to discover uniqueareas BangaloreWALKS, learningtofl For more information, contact 6:30am. starting Sat mornings ofultimategame onTues/Th Joinusfor MGRoad, a Grounds, Ultimate Frisbee er an enriching, pleasant pleasant er anenriching, [email protected] eForum, Garuda , Police is great isgreat e urs/ • • SIGHTSEEING “Th are day spas time. Amongthe best the upacross cityallthe spring ones East-meets-West culture, andnew ofBangalore’s much apart are very Spas available inBangalore. are easily treatments andspa Massages Spas Mall. theatre inGaruda Cinema inForum MallorInox city, Class splurge Gold at the PVR innumerable theaters around the Take at oneofthe inamovie Movies tickets. (“blocking”) buying/reserving whether the play isinEnglishbefore to double-check idea it isagood so languages, Shows are invarious at 7:30PM. showsstart the evening 45–100.Usually Rs. range between Tel: 26592777or26494656.Tickets J.P.8th Cross, Nagar, 2ndPhase. 36/2, Nagar, Rangashankara. called Th inJ. located ere isa theater hall P. Th • way to “treat yoursenses”. It’sColony (www.akaasa.in). aperfect ”akaasa” inDefence that islocated called spa latest high-endboutique hotels). Try 5-star and upcoming the parks tech totheBangalore close Whitefield (at area Marathahalli, inthe com, 080-42053467)opened (www.aromahomespa. Home Spa Cunningham RoadRecently, Aroma [080-41268111] andSPA.ce on offiDell Road ce onInnerRing eater e5th Element” Thnear spa ai Tipu Sultan’s Fort and Palace Secretariat Vidhan ortheState Soudha in Town. DayCafé in several or stadium around the bought be Tickets can Cubbon Park). Stadium M. Chinnaswamy match.Cricket (Near

INDIA 89

■ e GLOBAL FORUM GLOBAL the so that cers Global airs, AstraZeneca, while Changes, scientist, Sun Pharma, commented pharma Indian the industrythat along with the should work of India and ensure government adoption of regulatorychanges when they happen. Referring the to PWC report, companies he said that and ICH Q8, PAT the follow that ahead other Q9, and Q10 are of the competition. in the companies director, Shenoy, Premnath Further, regulatory aff speaking regulatory on the challenges during product development for there globalthe market said that is a need knowledge for sharing with regulatory offi whole process Th can be easy. session wasnext on compliance challenges, and it focused on topics like cGMP challenges in pre-approval as an inspections, use of PAT analytical tool risk for to mitigation and on productensure consistency, perspectivesregulators’ on meeting challenges.compliance members the All of the at present view of the were that conference good regulatory policy need is the both hour and that of the and industrygovernment should with each and collaborate work it. attain to other article wasis previously published Th 13, 2010 08:00 May ursday, on Th at http://www. Mumbai in IST, pharmabiz.com/article/detnews. asp?articleid=55433§ionid=9 Regulatory Challenges Conference Focuses on Focuses Conference willce be starting a quarterly rst session was on the e fi e e diff of from that in nature erent e diff generics,” she said. generics,” Giving short, a brisk on update pharmacovigilance, Dr Surinder Singh, DCGI, a having said that proper pharmacovigilence program is very important detection, for assessment, understanding, and prevention of adverse drug reactions. e needfor it arises since more Th global medicinesthe market for is growing ageng population the due to and increasing number of diseases. informed soonHe that (attendees) his offi will 1 that frompublication July on ADR and will information contain be in all medical circulated colleges. Th need to have operations that should need operations that have to b challenges during product deputy development. D’sa, Albinus country director (India), US FDA, who was also chairing session, the detailedgave on the information advantages new of the regulatory aspath a result of implementation of ICH product Q8, Q9, and Q10 for said that He design and quality. quality systema strong needs to development of the robust for exist industry do so industry the and to the to needs it according adapt to changing times and new regulatory developments. Speaking about the challenges faced industryby the during drug product development, Nitin Dharmadhikari, ey shared their ith a viewith the tap to challenges faced by the Indian pharma industry focused e conference

expectations and future plans with Th industry. keynoteIn the address, Dr Sadhna medical and clinical VP, Joglekar, research, GSK, spoke about the need line. She said patent erent a diﬀ for near in the future, specialtythat sectors like oncology and vaccine are is estimated that It grow. going to vaccinethe industry grow to is slated coming in the 47 peraround cent She also spoke about the year. challenges emerging biosimilar in the market. “In biosimilars we cannot like in genericoperate market. Since biosimilars, for thus we erent diﬀ it’s Th e event wasattended not only Th by people industry within the but from India regulators also by the US FDA.and the Th challengeson the faced by Indian pharma while manufacturers supplying drugs domestic to and global markets. Each session was planned on with presentations challenges faced industry by the and regulatorythe authorities. due to the change in the regulatory change in the the due to policies, was conference a three-day organized DIA by the on Global Regulatory Changes: Quest for ran conference e Optimisation. Th 9 and focused 7 to from May on the industry the challenges that is facing globally regulatory due to changes dealand how to with them. W 90 Zhang Wei, Yang, KE MD,Joseph Cho. Th (Leftto right) DingJianhua, session. opening e plenary CHINA

Head Asia-PacifiHead c R&Dsanofi Vice-President, R&Dand Global Co-chair Frank MD, Jiang, PhD, the number ofexhibitors. in well as as and sessions, program number ofworkshops, of participants, Annual in Meeting terms larger was ChinaNovember 2009,thesecond Annual Meeting, heldin which was tothefi Compared (SFDA). Administration andFood Drug State under China’s (CCPIE) Exchange InternationalPharmaceutical bytheChina for co-hosted Center Thover 700participants. was event e attracting success, great Beijing with held16-19May in was Execution” From to Innovation: Strategy D GLOBAL FORUM Drug Development & Development Drug for China Meeting “Priming IA’s China second Annual rst rst China - Presentations included: industry, andacademia. agencies, regulatory from speakers level high- ofthe SFDA, Cooperation ofInternationalDepartment ofthe General Director Deputy byDingJianhua, chaired was TheInnovation. plenary morning ofDrug the Challenges to Meet Supervision onDrug of the SFDA, Wu Commissioner Deputy Zhen, by address akeynote with session The day first featured anopening AdministrationDrug (SFDA). State Food and Exchange (CCPIE), for International Pharmaceutical Director-General ofChinaCenter Yajun, co-chairtogether with Zhao closely worked China (pACC), Councilof Advisory provisional ofDIA’s andmember aventis, workshop #1. workshop James Hung, HM PhD,atpreconference 2 Annual nd • • • Academic in Research Drug ofRole and Perspectives on; Association Development and Research Industry ChinaPharmaceutical President, Executive Policy; for Medicinal Center Research Association Pharmaceutical Chinese Director-General, Executive Innovation Ruilin, bySong Healthcare and Reform SFDA ofthe Registration of Drug Department General, Director Wei, Zhang of China by Industryon thePharmaceutical and Their Impacts Registration and onDrug Policies Implementation ofRegulations and Establishment The DIA at the plenary session. at theplenary Frank Jiang, MD,PhD, co-chair Program CHINA 91

GLOBAL FORUM GLOBAL Joint DIA—ACT Study DIA—ACTJoint Study 18–20 Director Workshop, October 2010, Beijing Statistical the Understanding in ClinicalThinking Research Drugfor Development, 4–5 November 2010, Beijing Phase I Clinical Trials—First Studies Workshop, In-Human 2010, Shanghai Fall Clinical Project Management 2010, Fall Workshop, Shanghai Upcoming DIA in Events China • • • • addresses the plenary session. Critical 1), Critical (Workshop ■ Annual DIA e 3rd China’s The 3rd DIA China Annual Meeting The 3rd DIA China Th Meeting is scheduled 2011 May for in Beijing. information, more For Chen: dia@diachina. Ting contact org Three preconference workshops workshops preconference Three the on on 16 May held were Drug Safety topics of Enhancing Prospectivethrough Planning, Effective and Evaluation, Timely Reporting Literature of the Medical Appraisal 2), and Clinical (Workshop and Auditing, Monitoring, Trial – FDA, Workshop Inspection SFDA, Industry and Perspective workshops 3). The (Workshop and attended, well were participants included over 30 SFDA.Provincial of the delegates e ered a ered Attendees at the “Program at a Glance” display.Attendees at the “Program at a Glance” Pomerantz, Paul Executive Worldwide Director, by Joseph & Cho, Present CEO, Astellas China,CEO, Pharma Chairman, RDPAC. Vice R&D: Th e Life Line for Pharma Line Life e R&D: Th Business – from a Perspective of GM Innovation and Development and by Innovation Executive Vice MD, KE Yang, University;President, Peking unique insight on the role China can role on the unique insight in leadership in drugplay development, as as well local, regional, and global perspectives on strategic positioning and research increasingly in the economic and regulatory complex pharmaceutical environment.” Richard Day, DIA President-elect and DIA President-elect Richard Day, Executive Worldwide Pomerantz, Paul Director of DIA “Th commented, program four featured extensive simultaneous tracks and oﬀ

•

China Meeting 92 CAREER TIPS

confi thatrm telecommuting has time. Telework part least consultants were WAH (workingat home)at March, 1.4millionCanadians past workforce And this telecommutes. that 20%ofits reported of telework, 11, 2009,IBM,another initiator early throughout theofFebruary world. As inthe oftelework current use growth reflNow, reports news Honeywell. Xerox, and ofAmerica, Bank SunMicrosystems, suchas pioneers concept inthe 1990sbytelework the enthusiastic adaptation ofthe following fashionable became Th 25years. over the last skyrocketed Jack Nilles—has the 1970sbyAmerican as early as back practice—introduced you are notalone.Th orforan employee yourcompany, telecommuting—is right for youas or nottelework—also as known consideredwhetherIf youhave ever ofoffi costs rising the with dealing director facilities data? Or,productivity are youa president vice a corporate reviewing for youatwaiting the offi W GLOBAL FORUM ere youstuck intraffi about alltheabout work thinking this morning ce space? e business ect ect rapid ce? Are you e idea c • fence: ofthe sides onboth experienced be fold. Th ere are dramatic to pluses employer are and employee multi- Th of telecommuting eadvantages to AND EMPLOYEES BENEFITS FOR COMPANIES teleworkers? adapt as benefi employees And howcan puttheintoalready process practice? that haveexperience ofbusinesses the companiesHow leverage can working remotely rather than onsite? what of areSo, the advantages and Australia. and Germany, inMalaysia well as as United Kingdom,the Netherlands, practice inthe apopular become • Benefi According to Workshifting productivity. Increased home gives them to accomplishhome gives thatthe workingat opportunity Why? Manyvalue employees telecommute.when employees ondays in productivity increase 15%and50% show between onaverage companies Network, oftheLister Telework Research inMay 2010byKateissued whitepaper Cirtrix-sponsored ts: ts: Th e Bottom Line, a Line, eBottom t and • • other necessities oflife. other necessities and repairs, car appointments, doctor with work deadlines integratehelp employees involve alongcommute can thattelework schedule doesn’t outthat afl points 101 Tips forTelecommuters, the also authorDinnocenzo, of VirtualWorks! of owner Dinnocenzo, Debra explains teleworkconsultant workfrom aren’t sick, really timeoff whotake people Why?in absenteeism. Many produce upto a20%reduction that these can programs He reports of telecommuting. to facilitate the implementation thatOttawa off in 20-year-old company based InnoVisions a Canada, andpresident of Association Teleworkof the Canadian FortierBob isthe president absenteeism. Reduced consultants. according telework to several colleagues, from visits social onworkand intrusions timeby meetings, unproductive gossip, the ofwater cooler distractions timewithout inless goals job ers procedures exible CAREER TIPS 93

GLOBAL FORUM GLOBAL rst-hand rst-hand cer, of Chicago- of cer, c parameters c responsible adults; we know they will theythat do what need do both to personally and that explains He professionally.” employees who need a “Astellas of quiet time or a few days day a project complete needto only request from time their the in advance.” manager a few days John C. Robak, Executive and Chief President Vice Operating Offi based Greeley and Hansen, , a rm specializing in practical fi engineering, architectural and infrastructuremanagement solutions, same the has to come from fi conclusion “I would recommend experience. as considering telecommuting arrangement work exible a fl corporate leaders….option to can help Telecommuting retain employeesemployers with specialties, unique address labor shortage, and can even er a distinct advantage over off competitors.” • basis specifi with and depending individual’s on the circumstances. is it executed? How A pilot program six of three to is followed up by a formal months assessment. (Corporate Motivation: talent. of top Employee retention t: sense a greater of autonomy Benefi and increased job satisfaction.) company, RobertaPresident Fox’s Consulting Telecom Group Fox Alberta,in Mount Canada, ON, helps clients adopt formal reportstelework programs. Fox CHOOSING A TELECOMMUTING STYLE A TELECOMMUTING CHOOSING Organizations and employees have a varietyfound of teleworking meetoptions to needs. their that Robak explains example, For Greeley and Hansen allow employees on a case-by-case telecommute to is project manager Robyn M. Bews resultsrms of these that confi trial runs productivity indicate increases 40%. She also of up to telework can enhance that states corporate image and provide especially if business continuity, an area is hit with bad weather or a pandemic outbreak. Th ts company, the not only benefi but also safety and ensures the employeeshealth of the and the community. entire Higher Satisfaction/ Job Employee Retention. Feeling trusted leads by an employer higher jobto satisfaction and according employee retention, Grant, report. Lister’s to Tim President, Human Senior Vice Resources, of pharmaceutical rm Astellas Pharma US, fi Inc.,agrees. put says, He “We our trust in our employees as • ects knowledge way the workers that

ce space costs. space ce rm with locations nancial fi nancial Enhanced corporate image and business continuity. Calgary’s “WORKshift” pilot program, funded by the government,Canadian Federal successfully encouraged organizations region in the to models.adopt telework Program • throughout the United States, United the throughout second the just completed stage of a pilot program in order seeto if real savings estate becould achieved a through policytelecommuting in the City area. New York Fortier often seesFortier clients realize reductions 20% than of more in real costs. estate or more Lorman, Director of Tim and Strategic Work Alternative reports that Space in Denver, a TIAA-CREF, his company, fi Decreased offi Decreased What made the transition to remote work possible? According to a 2009 to possible? work remote According transition to made the What a global human report issued by WorldAtWork, Trendline Telework and ts, work-life resources association focused benefi on compensation, integrated total rewards, high-speed along and wireless access Internet workspaces remote desktops and collaborative log onto to ability with the openedhave up these new possibilities. conduct business is conduct has work changed last in the 25 years. Traditional generally not conducted in-person in on-site locations based on sharing paper-based documents.be to Gover in helping innovator an continues Inc his As and CEO president of Teletrips, ciently. businesses run effi with States, experts Canada United and the throughout situated company, uses to assimilate world software the corporate clients throughout help to telework. Even today, changes in workplace practices continue. Ian Gover, once part once Ian Gover, practices continue. changes in workplace today, Even Sun Microsystems team, refl of that Telecommuting and its several variations a slow start got before the Telecommuting of personal American M. Nillesthe initiated Jack computing existence time and increase reduce commuting to ce offi rst teleworking satellite fi the mid-1990s, en, in Th company. an insurance for employee retention a Sun Microsystems team its initiated ground-breaking “Open Work system on with personnel telecommuting Practice” working remotely logging than corporate headquarters. in on-site at rather computers A HISTORICAL PRESPECTIVE A HISTORICAL PRESPECTIVE • 94 CAREER TIPS

headquarters inIllinoisthe other headquarters Utah andcommutes to corporate herhomein from twoweeks works month, Each Kenney Astellas. CommunicationsCorporate at Jenny Keeney. Manager, Associate forfor created ateleworkmodel isthe basis twolocations between commuting Long-distance andKansas. Connecticut situated in members department the of remotemanagement apromotion thatreceived involved Teixerarelocation to Florida, herrecentand Colorado.After away Kansas far place as as take companysome functions inConnecticut, is headquartered Whilethe companytelecommuting. of illustrates another aspect Connex International also satisfaction.) of autonomy andgreater job BenefiEmployee mobility,t: feelings staff Motivation: (Corporate homefull-time. from offi while5%ofthe staff ces, two days home from aweek company telecommute employees Teixeira,Gail that 10%of reports world. Its ofMarketing, Director communications throughout the conferencing to promote business that audio andweb provides Connex International, acompany at Suchisthe case two days aweek. usuallyoneor telecommuting, commonlymost use that andUScompanies Canadian GLOBAL FORUM performance evaluation policy. evaluation performance and Information the mailroom Technology, suchas telecommuting, anda aff units departments/business formulated input with key from teleworkmanual an easy-to-understand formanager motivation the pilot, include:acost/benefi steps Th teleworkpilots. recommendtheofformal use Jack (JALA) Nilles Fox Roberta Consultants (Fox Fortier Group), Bob (InnoVisions, Canada), TELEWORK PROGRAM IMPLEMENTATING ACORPORATE retention. part-time work t analysis, technology validation, staff validation, technology t analysis, that some job functions are that somejob just functions emphasized of theabove companies All representatives note: (Important satisfaction.) job autonomy andenhanced increased retention. Benefi Employee employee Motivation: (Corporate satisfaction withthe program. telecommuters refl of ahighlevel ect recently full-time held these with meetings Informal data managers. of the company’s statisticians and work homeoffi from dosome as ces, staff these at hospitals, offi patients’ data at doctors’ trial clinical late-stage monitoring are not Whenthey Associates. Research ofClinical team by its States intheUnited telework full-time includes of this policy McGuire explains that onefacet supervisor. and prospective telecommuter the prospective both of evaluation acareful only after are made telework arrangements that the world,reports PharmaNet throughout multiplewith locations company services development McGuire. Adrug Rosemary President ofHuman Resources Vice reports telecommutes, workforce ofPharmanNet percent ofthe total Seventeen satisfaction.) job and increased fl retention. Benefi Employee andemployee productivity Advantages: (Corporate two weeks. exibility in living arrangementsexibility inliving ected ected by members and t: e ts: ces or colleagues? intouchwith or justtokeep meetings, to for the staff office trips to makeperiodic you willing are onyourown, if youlikebeing workers? And,onthe other hand, ofco- thewithout camaraderie deadlines andmeeting goals Will youfeel isolated pursuing What the about factor? sociability Fox. adds Roberta communications andwork habits? in changes make the necessary to are youwilling traits, these day?” Andifyoudon’tevery have done to be to what know needs youhaveDo the razor-sharp focus enough to work independently? andself disciplined you motivated “Areself-appraisal. yourself: Ask anhonest with telecommuting start whoare contemplatingindividuals recommendsthatDinnocenzo, but assessments, or informal formal offer corporations Some whether ornotto telecommute? time?How doyoudecidefirst this work-life choice for the what ifyouare facingBut, clients. pharmaceutical to cultural anddiversityservices andcross- practices, telework best that off consultancy global based Jersey- aNew Inc., Dynamics Global Dr. president of Goodman, Neal “telecommuting jobs,” out points that are bynature full-time executives, sales pharmaceutical Th as such ere jobs, are IS TELECOMMUTING RIGHTFOR YOU? employees.) equivalent foron-site tothose guidelines onperformance based the right toterminate thepolicy employermaintainsthe corporate in eithercase, but, work options, telecommuter initiate can remote manager ortheprospective thateithertheprospective explained not suited fortelecommuting. Th ey ers CAREER TIPS 95

ce ce GLOBAL FORUM GLOBAL Separate and family work space home working at Remember that child- or for is not a substitute eldercare Consider purchasing offi ergonomic comfortable, equipment • • • STAY ON TRACK WITH THESE WITH THESE ON TRACK STAY TIPS TELECOMMUTING reside in vastly separate parts of parts in vastlyreside separate of world. the CAN GET TELECOMMUTING WHERE TRACK OFF Some full-time, on-site employees jealousare who co-workers of some while off-site telecommute, about to having complain workers also are office. the There go into uncomfortable managers who are of sight” supervising “out employees. Baltimore executive Joni consultant management reportsDaniels it takes that effortmore even for forward- get input thinking managers “to they since from telecommuters not in an officeare down right hall.” the alsoDaniels points for out that fewer are teleworkers “there opportunities social for interaction And meetings.” and impromptu even telecommuting consider don’t of attaining thoughts if you have position,an executive adds Dinnocenzo. is that danger common Another know when often teleworkers don’t result is a The up shop.” “close to predictable stage of telecommuting –burnout - which often leads to and unnecessary a premature telework of the termination process, Roberta says J. Fox Telecom Group of Fox President Consulting. assess ow ce Consult with your supervisor about hours your preferred work ts in with and discuss fi how that fl team work the be afraid ask help. to for Don’t on-site if you were Remember, just pop your you could in to supervisor’s offi Distribute all your phone numbers, email addresses, and co-workers to info contact other leaders also need be to Team and responsible initiating for fostering communications workers among remote • • • • Both Global Dynamics, Inc. and Guided Insights provide specialized methods ensure that successful collaboration the teams where work of remote coworkers company multinational measure results. which will your supervisor help support ce any existing policies or among existing any within your company the results at the end of each month and at the end of the end of the the and at end of each results the the month at Write a formal proposal, Write your case superiors. his to possible Anticipate managerial objections. ts both to you and Consider how you would respond and include benefi company. the to and include a way three months Evaluate period.three month you en, determine what Th nd out why. If your proposal is rejected, fi it.can reintroduce do to yourself and what you have accomplished. accomplished. you have and what yourself Research telecommuters. and talk other competitors to week, not just a day here or there, telecommuting; then honestly then week, telecommuting; or there, here not just a day instant messaging,instant Skype or inform coworkers to Facebook your home offi if you leave meeting, a client for dental appointment, or lunch Use newUse technology such as Keep with supervisors in touch regularly with set phone time” in “real appointments INITIATING A TELEWORK PROGRAM INITIATING WORK FOR YOURSELF AT 2. 3. 4. Suggesta temporary a week for three days trial example, period. For 5. 6. 1. Spend several telecommute. you really or a want to Make sure days Th e following is based on information contributed by Tory Johnson, following e is basedcontributed by on information Th Hire. For Women and CEO, from Home, Work of Will co-author • Solo-telecommuting practitioners Solo-telecommuting practitioners on independent who work projects an advantage as at are opposed who telecommuters to aswork part or an of a remote in-house in the team. If you are group, take of these note latter caveats supplied communication President by Nancy Settle-Murphy, of Guided Insights, a telework and consultancy utilizes that her 20 years in virtual of experience basedcollaboration in Boxborough, Massachusetts. • • Take time out for breaks to training and development and/ who face today’s tough economic stretch or exercise or scheduling adjustments can challenges, and to employees overcome many of the bumps along who seek balance between work • Adopt general health rules, the telecommuting road. and personal time. A side benefit including good eating habits. of telecommuting is that there For instance, managers who will be fewer commuter-filled • Get out and meet colleagues aren’t comfortable overseeing cars burning fossil fuels, for lunch or for professional off-site workers may benefit from polluting the air, and clogging networking meetings training to learn that “face time” the highways. doesn’t necessarily equate to • Make after-work dates with productivity. On the other hand, Th e bottom line is that each friends from time to time Fox suggests that scheduling individual and each company must adjustments to the predictable evaluate the telework options STRIKING THE RIGHT BALANCE burnout phase can lead to greater available to them and weigh the Sometimes telework just won’t job satisfaction as well as an advantages for themselves. It’s a work. Sometimes, it’s the nature increase in time for leisure, family, decision that could save time and of the job and sometimes it’s the or volunteer pursuits. money while producing better personality of the individual. But, results, more satisfi ed workers, in many cases, most telecommuting On the whole, telework can be and less “road time” for millions experts agree, formal pilot projects, a win-win for both employers of workers. ■

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96 GLOBAL FORUM

CT1-Career Tips.indd Sec1:96 7/19/10 11:09:28 PM 4th European Forum for Qualiﬁ ed Person for Pharmacovigilance (QPPV) BrianBrian EdwardsEdwards

ot to be deterred by a legal perspective with a lively session, involving MHRA inspector, volcanic ash closing discussion about effi cacy studies, concerned how QPPV needs N European airspace, this the use of a black symbol to indicate to be involved in partnerships year’s QPPV Forum was successfully intensive monitoring and the with other companies and input rescheduled from 21–22 April 2010 involvement of patients. Th e second into alliance agreements as to 24–25 June 2010 at the Hilton session was based on the views from well as maintain oversight over a national Competent Authority. outsourced pharmacovigilance Emphasis was placed on the new activities. The next session was legal status of the Pharmacovigilance about the place of the QPPV in Risk Assessment Committee risk management plans from the on a par with CHMP itself. viewpoint of a big company and Improvements to EudraVigilance the EMA. The meeting ended are to be expected. A lively panel with an entertaining session where discussion between the panel and QPPVs were educated about social the fl oor closed the session. networking and then challenged about how to influence within their Session 2 focused on “What’s organizations. Hot for the QPPV” with the fi rst talk from EMA covering the new Following the meeting it has been business rules for EudraVigilance, agreed that European QPPVs the future role of ENCePP in risk and deputies will have their own management, the PROTECT group and dedicated networking programme and international platform on the DIA website and collaboration. Th e second talk that the future title of the group was from the MHRA inspectorate will be the “EU QPPV Forum.” about compliance of marketing For more information about the programmes and internet activities. EU QPPV Forum, please contact Th e third talk followed on naturally Sarah Schuppener, Volunteer describing a big company’s Services Coordinator, DIA Europe, pharmacovigilance experience Elisabethenanlage 25, CH-4002 Basel with data posted to a website and (Tel: +41 61 225 51 62 ; Fax: +41 61 London Metropole in London, UK. message board. Sessions 3 and 4 225 51 52) or sarah.schuppener@ Attendance at this meeting has concerned talks discussing personal diaeurope.org ■ increased year on year achieving liability of the QPPV, advice about around 140 delegates this year. Th e personal employment rights and meeting was co-chaired by Vicki contracts as well as varieties of Edwards (Abbott Laboratories., UK) ways QPPVs interface with diff erent and Karen Pattenden (Gilead departments in a company and Sciences International Ltd., UK). how due diligence is important in PROGRAM NOTES Notably, as the fi rst reading about the contracting out the QPPV’s- role. amended pharmacovigilance directive 2001/83/EC was passed the Day 2 began with a talk describing day before, this was the fi rst meeting a big company’s experience in to discuss its signifi cance. updating their DDPS across their product portfolio. This was Th e forum opened with two followed by a joint presentation consecutive sessions about the from two large companies where Brian Edwards is Scientifi c Advisor updates to the EU legislative two QPPVs reflected on their Pharmacovigilance and Drug Safety, framework. Th e initial session was experience of mergers. The next NDA Regulatory Science Ltd., UK. GLOBAL FORUM 97 98 PROGRAM NOTES Session presenter Douglas J. Peddicord Douglas presenter Session

Annual MeetingSessionReport: GLOBAL FORUM Rikki Hansen Bouchard, MPA, Bouchard, Hansen Rikki RH Bouchard & Associates, Inc. &Associates, Bouchard RH Association of Clinical Research Research ofClinical Association Director, Oﬃ Deutschland GmbH,Germany Deutschland Bruce Binkowitz, PhD, MSc, PhD, MSc, Binkowitz, Bruce Boehringer-Ingelheim, France Session chair & panel Session chair&panel Nancy Myerson-Hess, MSc, MSc, Myerson-Hess, Nancy Douglas J. Peddicord, PhD, J.Peddicord, Douglas Deputy Center for Director Deputy Harry Staines, PhD, MSc, PhD, MSc, Staines, Harry Harrison Featured panelists: Robert T.Robert PhD, O’Neill, Session presenter: Robert J.Temple,Robert MD, Clinical Science, CDER Science, Clinical Genzyme Corporation Genzyme Organization (ACRO) Organization Merck &Co.,Inc. Andy Lee, MA, MA, Andy Lee, moderator: Clinical Research Research Clinical ce of Biostatistics, CDER deal withthis.”deal howwe’re tothe see ring goingto to throw their hat into for everybody “It’s concurred. O’Neill Robert time together,” group multidisciplinary “It’s to putthis idea agreat other.” ofeach are independent thatthe you’re processes at looking diﬀ butnoneof ofview erent points said. “Everyone’s at this from looking panel,”put together adiverse Bruce “Thpanel discussion. was to eidea for the subsequent the framework presentation established whose Peddicord,including presenter Doug panelists, theintroduced discussion Binkowitz chairBruce Session (MRCT). trial conducting clinical amultiregional of andchallenges opportunities the to discuss leadership andregulatory panel ofindustry #104) convened aninternational (Session a Global Village ofExpertise A utrgoa lnclTil:ItTakes Trials: Clinical Multiregional before. than ever regions inmore conducted currently being expansion, are trials more clinical continues global its enterprise research clinical and development s the drug pool: “If real estate is about ‘location, ‘location, estate isabout “Ifreal pool: of MRCTs isthe population expanded MRCTs. Th of disadvantage is the overriding over-burdenedalready enterprise” the complexity“Increasing ofan ofMRCTs.and disadvantages the advantages He then summarized research,” concluded. Doug much expanding the arena ofclinical companies are very pharmaceutical and and their in biotech customers 2009. “Th beingCROs point that e 2004and between by 266%inKorea, 50% inJapan,and by93%inRussia, bynearly increased trials clinical the of number by 2010.Elsewhere, to toestimated grow $1.5Bannually $30M,andis in Indiatotaled activity In 2004,annual trial clinical exception). onepanelist took least (ROW –anexpression to which at inthe oftheconducted rest world Union; the remaining 30–35%are 20% areinthe conducted European andanother intheconducted US, are trials clinical 45–50% ofglobal ApproximatelyClinicalTrials.gov: compiled from onfacts based research,” ofclinical the globalization According to Doug’s “overview of e most obvious advantage advantage obvious emost PROGRAM NOTES 99

■ cation, and cation, GLOBAL FORUM GLOBAL (#10034), e regulatory e Dr. Binkowitz will also serve Dr. our upcomingas for co-chair Ensuring Quality conference & Balancing Risks for Multiregional Clinical Trials: Statistical, Clinical, Regulatory, and Ethical Factors which will be co-located with Project Manager: Tomorrow’s CompetenciesEvolving for Biopharmaceutical Professionals Hotel DoubleTree the (#10028) at & Executive Meeting in Center Bethesda, October 26–27. MD, clinical trials now outsourced, are investigators, sponsor, study and the clearly identify must and regulators who is responsible handing for whom. Th to off what process must adapt more quickly and quickly more process adapt must sourcing model, this to thoroughly evenand might need expand to sourcing and into robustly more processes,contracting too. Other discussions included the ect in trials in emerging eff placebo regions, certifi investigator be to fully issues tooother numerous discussed single session. in this nition xed way xed languageserent and dialects, such o from the investigators living and investigators o from the from scientists and statisticians butfrom scientists and statisticians als of looking at it,” Nancy said. of looking it,” at Robert O’Neill agreed. “When we review we review a protocol, it on its c merit, not its operational scientifi deal the he said. “But that’s merit,” breaker.” becauseAndy Lee suggested that are patients and clinical investigators people, and people by defi are it is critical educate unpredictable, to patients and train investigators respectiveon their roles and responsibilities meet to objectives the Nancy provided several study. of the reasons standardized why training local the at level is important, especially research when conducting many in emerging regions which have diff as India and China. Rikki Hansen Bouchard and Robert O’Neill issue of introduced the clinicalcontracted research – CROs. agreed e panel that are CROs Th increasingly taking clinical over the research global infrastructure. Most working with the local population. “It’s localworking with the population. “It’s no fi ere’s operation.a joint Th is is the erence be?” erence e critical e

exchange to e panelists continued Nancy Meyerson-Hess expanded importanceupon foundational the of people in clinical research. For designingexample, an MRCT study requires not only protocol input question answerto is: “What would reasonthe diﬀ this for Th ideas and perspectives their throughout discussion. and far-ranging enthusiastic “It’s worth noting that there are going are there worth noting that “It’s betweenerences regions,” beto diﬀ Robert Th continued. ‘elephant in the room,’” Bruce agreed. room,’” in the ‘elephant “What is a “region”? exactly Bruce then openedBruce then panel the discussion with several slides designed and focus facilitate to discussionthe topics. Robert and Harry Staines both Temple populationspointed in out that such as countries large India or homogenous, hardly US are the and wondered if discussions of regional characteristics really are about genetics instead. “Th location, location,’ in some sense location, location,’ clinical research is about ‘numbers, Doug suggested. numbers, numbers,’”

Session chair BruceSession Binkowitz chair the distinguished and panel Clinical Trials Multiregional Election Results

hehe results of tthehe 2010 DIA election have been ratifi ed, and the members below have been elected to the Board T of Directors. Th e Board sets the overall stratestrategyggyy forfor DIADIA activities,activities, pprovidesrovides fi fiscal oversightoversight for the association, aandnd strengtstrengthenhen DIA’DIA’ss programs and services worldwide.

President-Elect Treasurer of Public Affairs of Aventis Pharma.

Yves served as the Chairman of EFPIA Scientific Technical and Regulatory Policy Committee from 1991-2002. He was a member of the ICH Steering Committee from 1996 to 2006, where he represented the European Pharmaceutical Industry and was the Chair of the Global Cooperation Group (ICH – rest of the world). He has served as chairperson of the Yves Juillet, MD IFPMA (International Federation Minnie Baylor-Henry, JD of Pharmaceutical Industries and Yves Juillet is currently Associations) Regulatory Policy Minnie Baylor-Henry is currently Senior Advisor to LEEM (the Committee since 2004. a Consultant in the Life Sciences Pharmaceutical Industry Regulatory Practice at Deloitte Association in France). He Yves has been involved in DIA & Touche LLP. Prior to joining received his MD in 1975 from the activities since 1990. He chaired Deloitte, she was the Vice University of Paris and is Board several tracks and sessions at President for Global Regulatory qualified in Cardiology, Intensive Annual and European DIA Affairs – OTC, McNeil Consumer Care, Internal Medicine, and meetings and gave numerous Healthcare, a Johnson & Johnson Pharmacology (MSc). He was presentations dealing with Company, where she served Head of the Clinical Department regulatory, clinical and public on the Leadership Board for the at Broussais Hospital in Paris and policy issues. He was a member company. Prior to joining McNeil, Assistant in Pharmacology at the of the Annual Meeting Program Minnie worked for another J&J University of Paris. Committee in 1994, 1998, and company, Johnson & Johnson 1999, and of the Euromeeting Pharmaceutical Research & Yves joined SNIP (now LEEM) Program Committee in 2000 Development (“PRD”), as a Senior in 1982 as Scientific Director, and 2003-2006. He chaired the Director, Regulatory Affairs, before becoming Deputy Director EuroMeeting Program Committee where she was responsible for General in 1987. In 1991, he joined in 2004. In 1998, he received a DIA the regulatory oversight for Roussel Uclaf in 1991 as Inspector Outstanding Service Award. He promotional activities at several General and became Director of was a member of the DIA Board of J&J Companies. Before joining Pharmaceutical and Public Affairs Directors from 2002 to 2008 and J&J in July 1999, Minnie was the

ASSOCIATION NEWS ASSOCIATION of Hoechst Marion Roussel in is currently a member of the DIA US Food & Drug Administration’s 1995. In 1999, he became Director Advisory Council for Europe. (“FDA”) Director, Division of Drug 100 GLOBAL FORUM Marketing, Advertising, Affairs for cardiovascular drugs at Parke- and Communications (“DDMAC”) Davis in France. of Biotechnology Industries in the from 1995-1999. Before becoming National Associations Council DDMAC’s Director, she worked Steve received his medical degree from of EuropaBio, and he serves on a as a Regulatory Review Officer the Faculté de Médecine Saint-Antoine, number of regional committees such and Branch Branc Chief. She also has Université Pierre et Marie Curie (Paris the Executive Committee of Europe’s servedserved as the FDA’s National VI). He completed his internship and ﬁ rst meta-region of life sciences, HealthHealth FraudFr Coordinator in residency at Assistance Publique - ScanBalt. Per has been active in the OfficOfficee of Regulatory Hôpitaux de Paris and prior to joining various DIA volunteer positions: Affairs.Affairs. industry, practiced medicine at the the Biotechnology and Non-Clinical academic hospitals of Paris with a focus Special Interest Communities, MinnieMinnie iiss a pharmacist and on emergency and intensive care. Program and Training Committees, anan attorney.attorn She received her Advisory Council of Europe and pharmacypharmacy degree from Howard Steve’s accomplishments in industry others. He is member of the Editorial University’sUniversit College of Pharmacy include the global registration of several Board of the Drug Information and her law degree from Catholic new chemical entities, successfully Journal and received the DIA University’s Columbus School managing complex business and Outstanding Service Award in 2002. of Law. regulatory issues, and assembling and leading high-performing teams. Directors Special Expertise Director

Steve Caﬀ é, MD Per Spindler, DVM, E-MBA, MSc Truus Janse-de Hoog, MSc

Steve Caff é is Vice President, Per Spindler has industrial Truus Janse-de Hoog studied Global Regulatory Aff airs and work experience in scientifi c and organic chemistry and pharmacy in Pharmacovigilance at Baxter managerial positions at H. Lundbeck, Amsterdam and Leiden. International where he has led the Novo Nordisk and most recently global transformation of the function as Vice President of a smaller Novo She specialized in hospital pharmacy since January 2006 across business Nordisk spinoff , BioImage. Per has and worked for 10 years as units and regions. Steve has 20 years a solid drug regulatory background pharmacist in several hospitals, the of experience in the pharmaceutical from the Danish Medicines Agency last 6 years as head of the pharmacy. industry in medical aff airs, clinical and and the scientifi c committees of regulatory development, and product the European Medicines Agency. Truus joined the Registration safety across all major therapeutic He served as amember of the Department of the Medicines ASSOCIATION NEWS areas and including drugs, biologics, CHMP Safety Working Party for Evaluation Board (MEB) in vaccines, and medical devices. a number of years. Per is member 1989, where she worked as the of Society of Toxicology and Th e head of a unit. In the beginning, Before joining Baxter, Steve was Organization for Professionals Truus was mainly involved in Vice President of Global Regulatory in Regulatory Aff airs, and he is a national procedures, but in 1995 Development at Aventis and sanofi-aventis EUROTOX Registered Toxicologist. she was appointed as the Dutch in Bridgewater, NJ from 2001 to 2006. He Per serves on the Scientifi c Advisory representative in the Mutual also previously held positions of increasing Board of the Research Institute Recognition Facilitation Group responsibilities in both international and for Medicines and Pharmaceutical (MRFG) in 1995. Th is group was domestic Regulatory Affairs at Merck & Sciences, Faculty of Pharmacy, overviewing the Mutual Recognition Co. in West Point, PA from 1992 to 2001. University of Lisbon. He currently Procedure. Truus chaired this group Prior, he was responsible for Medical represents the Danish Association twice during the Dutch Presidency. GLOBAL FORUM 101

What is it and why do you have to do it?

IA is accredited by the is not able to participate in the of its educational activities of the Accreditation Council for educational program. fi nancial relationships provided by DPharmacy Education the faculty. If a speaker does not (ACPE), the International A commercial interest is defi ned as have any fi nancial relationships Association for Continuing “any entity producing, marketing, to disclose, that too, needs to be Education and Training (IACET), re-selling, or distributing health care communicated to the learners. All and the Project Management goods or services consumed by, or disclosure statements are included Institute (PMI) to off er continuing used on, patients.”1 Th e relationships in a disclosure document in the education credits to participants in with these commercial interests that participant materials provided on- its educational programs. As an need to be disclosed include grants/ site. accredited provider, DIA is required research support, stock shareholder, to ensure that anyone in a position to consultant, honoraria, speaker’s DIA appreciates the support control the content of an educational bureau, and other fi nancial support. of its program chairperson(s), activity discloses all relevant fi nancial Faculty is not required to provide committee, session chairs, speakers, relationship(s) with a commercial DIA with the dollar amount received, and panelists in completing the interest. Relevant fi nancial just the type of relationship. disclosure form and providing the relationships are defi ned as fi nancial requested information. If there are ASSOCIATION NEWS relationships in any amount within Once DIA receives this information, any questions about disclosure or the last 12 months that may cause a it is up to them as the accredited how to complete the disclosure confl ict of interest. Th is is not limited provider to determine if the fi nancial form, please contact Jennifer to those involved in the educational relationship presents a confl ict of Andree-Webb at Jennifer.webb@ program, but it also includes the interest. If a confl ict does exist, DIA diahome.org. spouse and/or life partner of the must resolve the confl ict prior to the individual. According to the commencement of the activity. Reference: Standards for Commercial Support1, 1. ACPE Standards for Commercial which have been adopted by the After receipt of all fi nancial Support. http://www. ACPE, if an individual refuses to relationships and resolution of all acpe-accredit.org/pdf/SCS_ disclose, or does not provide the confl icts of interest, DIA is also Standard%205_February%202009_ requested information, he/she required to inform the learners update.pdf. Accessed 6/29/10. ■ GLOBAL FORUM 103 n New Orleans, where Alicia cancer at 44,” says Alicia, managing the effi cacy of fi ve weeks of radiation Pouncey lives, most folks director of Aureus Research delivered via an implanted device. I describe life in one of two ways. Consultants and a member of the Although she was interested, Alicia Th ere’s “before the storm” and there’s DIA faculty. “But at least from my was unable to qualify for the study “after the storm.” father and me going through this, because the cavity where her tumor I’ve gained a diff erent perspective. It’s had been was located too close to the Hurricane Katrina was Alicia’s reinforced what I believed before and surface of her skin. Without a trial to temporal landmark too, until helped me to see the bigger picture.” consider, Alicia moved forward with January, when she was diagnosed targeted radiation therapy. Th ree days with breast cancer. Th ree months Alicia’s experience with cancer began into her treatment, her 71-year-old later, her father was diagnosed with last winter. She was playing with her father was diagnosed with early stage pancreatic cancer. Suddenly, life fell dogs when one of them jumped up pancreatic cancer. into two new categories: “before the on her. As she pushed the dog off diagnosis” and “after the diagnosis.” her chest, she felt a lump in her left “Th ey don’t do trials where he was breast. Hoping the lump was merely diagnosed in Mississippi,” Alicia A site monitor with years of a mass of fi brous tissue that would explains, “and my parents were coming experience in the clinical research go away; she waited a few weeks to down to visit me a lot anyway, so he industry, Alicia says her personal visit the doctor. Unfortunately, a came to New Orleans to have his experience with cancer now enables biopsy showed otherwise. Alicia was tumor removed. It kept both of us from her to see her fi eld through a diagnosed with Stage 1 breast cancer wallowing in our own self pity,” she says. diff erent lens. She has an even greater and underwent a lumpectomy. appreciation for the importance of Like Alicia, her father was medical research and a new sense of During her initial evaluation for her approached about a trial. During empathy for research volunteers. follow-up radiation treatment, the their initial meeting, the surgeon radiologist described a clinical trial he described a trial that was testing the “I won’t say I’d wish this upon my thought might interest Alicia. Rather eff ectiveness of treating prostate

PATIENT PERSPECTIVE PATIENT best friend or that I’d have wished than receiving six weeks of targeted cancer patients with four weeks of when I was 10 that I would get radiation, the trial was investigating chemotherapy prior to surgery. 104 GLOBAL FORUM Alicia remembers sitting on the only reduce my risk of recurrence As a patient and the family member couch with her father and walking in 10 years from 8 percent to 6 of a patient, she knows what it feels through the voluminous informed percent,” Alicia says. “I owe the fact like to be suddenly inundated in consent form. She drew on the back that chemotherapy was an ‘option’ information; to drown in facts. of the document, trying to explain the for me to all the researchers and trial to her father. She defi ned terms all the women who volunteered to “I didn’t think there was a point where like “clear margins” and explained participate in a clinical trial fi ve years one could be too informed. Now I arcane industry acronyms. “I can’t ago.” think there is a plateau. Th ere really imagine someone going through that are limits to the information that one document with a family member and Although she’s still regaining her can convey. To say to someone who not knowing at least something about strength, Alicia is back at work with has just learned they have pancreatic the industry,” she says. a fresh perspective. “With a serious cancer, ‘Now let me talk to you about illness you feel like crap and you’re a study,’ and to think that all that can While her father asked a lot of forced to lie down and stare at the take place in one setting is a little excellent questions, ultimately what he ceiling,” she says. “You have to stop short sighted.” What’s more, she says, wanted to know from the researchers the pace that your life usually moves voluminous informed consent forms was, “what would you do?” at and refl ect.” further complicate the matter. “I don’t think a 25-page document necessarily “Th e informed consent process runs She’s had time to refl ect on the fact that makes a more informed patient than a counter to the way many people most researchers have never walked a 5-page document,” she says. are socialized,” Alicia says. “It is so mile in the trial volunteer’s shoes. inconsistent with how we are normally Th oroughness, education, patient treated when we visit a doctor.” “I teach a lot of classes for research confi dentiality, it’s all important, Alicia People are accustomed to hearing professionals and always ask, ‘How says, but in the end, it’s humanity and a physician advise them on the best many of you have ever participated the human touch that must prevail. course of treatment. Th ey see doctors in any type of study?’ It’s always less as individuals dedicated to improving than 5 percent of the people in the “Patients want to be treated,” she the patient’s health and well-being. “It room and these are people in the says. “As a patient you really don’t illuminates the need for some other industry!” she says. care that someone didn’t dot an ‘i’. way to do this informed consent You care that they sat and listened process. We need to move the person Not only are researchers failing to set an and cared. Patients don’t care about who plays the dual role out of the example and make a statement about the paperwork. Th ey don’t care about process and get a neutral third party in.” the importance of clinical research, database locks. Th ey care about the they’re missing an opportunity interaction.” ■ In the end, Alicia’s father decided the to understand what volunteers trial was worth pursuing. He signed go through. She notes how easily the consent form, but was disqualifi ed researchers use words like “nausea” and from the trial because his albumin “vomiting” and quips, “there should be levels did not meet the study criteria. a way to simulate nausea and vomiting for them” so they can better understand Today, Alicia and her father are what patients experience. recovering. Alicia’s father underwent surgery on April 13 and will not She’s thought about the fact that be undergoing chemotherapy less than 5 percent of oncology

treatments until late this year. Alicia patients participate in clinical trials. PATIENT PERSPECTIVE completed her radiation in mid- “We don’t have a cure for pancreatic Ken Pouncey and his daughter, April. Her lymph nodes are cancer cancer,” she says. “Why wouldn’t a Alicia Pouncey. free. She takes Tamoxifen to help person consider a trial? We haven’t prevent a recurrence of her cancer, talked about research in our culture Th is story is from a series of but decided to forego chemotherapy. in our everyday discussions.” articles created by CISCRP as part of their educational awareness A decade ago a combination of Most of all, she’s thought about the campaign to increase public radiation and chemotherapy would heroes: the professionals who push understanding that those who have been standard for a tumor the scientiﬁ c envelope, the volunteers volunteer to participate in clinical like Alicia’s. But doctors now know who step forward to help them do trials are genuine “Medical that “with my type of tumor and it, and the people who support them Heroes.” stage, undergoing chemo would throughout the process. GLOBAL FORUM 105 MARKETPLACE

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