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IN THIS ISSUE Special Section Drug Development in Emerging Regions Part 2 GLOBAL ggff forumFEBRUARY 2013 VOL 5 • ISSUE 1 INFORM ADVISE REACH EDUCATE IN THIS ISSUE SPECIAL SECTION DRUG DEVELOPMENT IN EMERGING REGIONS PART 2 PAUL POMERANTZ’ REFLECTIONS PAGES 9-13 We have the answers and solutions to your life science translation questions. Whether it’s translating an informed consent or linguistically validating a PRO instrument into 52 languages, Corporate Translations can manage any translation request. Our unique processes, elite translation teams, and LQQRYDWLYHWHFKQRORJ\VROXWLRQVKDYHSURYHQWREHPRUHDFFXUDWHHIÀFLHQW and cost-effective than those of our competitors. We understand the critical need for quality translations, and we deliver. That’s why Corporate Translations is the preferred supplier of ISO 9001:2008 translation and linguistic validation solutions to the world’s leading life science companies. www.corptransinc.com 1-855-727-6003 Translation | Linguistic Validation | Desktop Publishing | Translation Memory Management | Document Libraries Driven by DeÀnition® CONTENTSCONTENTS ggff 11% Indian Non- Indian 89% INFORM ADVISE REACH EDUCATE ASSOC. NEWS 14 36 44 86 100 Open Forum 4 Mapping Regulatory, Health Technology Andrzej Czarnecki Assessment, and Coverage Decision- Making Processes: A Key to ANNOUNCEMENT: Multistakeholder Understanding 28 Statement from DIA Lawrence Liberti Worldwide Executive Director 6 Efficient Regulatory Medical Writing Statement from for Global Submissions in “ICH President, DIA Board of Directors 7 Outlier” Authorities 31 President’s Message 8 Frank Hubbard Ling Su ADVISE 36 We have the answers and solutions to Executive Director’s Message 9 Into the Cloud: New Technology 1 Paul Pomerantz Blowing In Big Benefits to your life science translation questions. Regulated Content Management INFORM 14 Whether it’s translating an informed consent or linguistically validating a in Life Sciences 37 Clinical Drug Development Jennifer Goldsmith PRO instrument into 52 languages, Corporate Translations can manage in Emerging Markets 15 Divide and Conquer 41 any translation request. Our unique processes, elite translation teams, and Jean Soul-Lawton Martin Magazzolo LQQRYDWLYHWHFKQRORJ\VROXWLRQVKDYHSURYHQWREHPRUHDFFXUDWHHIÀFLHQW Early Clinical Drug Development in and cost-effective than those of our competitors. We understand the India-Opportunities and Challenges 16 REACH 44 critical need for quality translations, and we deliver. That’s why Corporate Savita Dhillon Translations is the preferred supplier of ISO 9001:2008 translation and Recent Development of Activities in LATIN AMERICA linguistic validation solutions to the world’s leading life science companies. Phase 1 Clinical Studies in Korea 18 DIA’s 5th Latin American Min Soo Park Regulatory Conference 45 www.corptransinc.com Clinical Trials in the Commonwealth NORTH AMERICA of Independent States (CIS): 1-855-727-6003 Factors for Success (from Feasibility DIA Presents RIM 2013 47 to Close Out) 21 Sarah Powell Andrei Kravchenko Medical & Scientific Maxime Stevens Communications 2013 48 Translation | Linguistic Validation | Desktop Publishing | Translation Memory Management | Document Libraries Sino-American Pharmaceutical Marketing Pharmaceuticals 2013 49 Professionals Association (SAPA): DIA 2013 Keynote Speaker Discusses Bridging the Gap between Industry in China and the United States 26 Innovation 51 Laura Hong “Exhibitor Invites” Return for Sean Zhang DIA 2013 49th Annual Meeting 52 Weiguo Dai “Hello, But I Must Be Going Now” 53 Bin Shi Keith Wenzel DIA President’s Personal Invitation to Students 55 Driven by DeÀnition® gf GLOBAL FORUM The Global Forum (ISSN: 1944-1991) is a publication of the Drug Information Association. Editorial Office: Drug Information Association (DIA), 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, USA; phone - 215.442.6100; PUBLISHING fax: 215.442.6199. INFORMATION Copyright © 2012, Drug Information Association. The Global Forum (ISSN: 1944-1991) is published six times a year, in February, April, June, August, October, and December. Paul Pomerantz, Executive Director Periodical postage paid at Horsham, Andrzej Czarnecki, MD, PhD, DSc, Pennsylvania, and additional mailing offices. Editor-in-Chief Thirteen dollars of each member’s annual Global Forum Staff membership fee is for a year’s subscription. Judy Connors, Associate Director, Prices include postage and are subject to Editorial Services change without notice. Notify DIA eight weeks Chris Slawecki, Senior Copywriter in advance of address change with a copy Jenny Kimbel, Senior Editorial Assistant of the mailing label. Back issues of most Joe Krasowski, Sr. Digital Content Strategist previously published issues are available from DIA. Mission PUBLICATIONS MAIL The Global Forum provides a multidisciplinary, AGREEMENT NO. 41103506 neutral forum for communicating information 2 RETURN UNDELIVERABLE CANADIAN related to drug development and lifecycle ADDRESSES TO CIRCULATION DEPARTMENT, management on a global basis. The Global PO BOX 1051, FORT ERIE, ONTARIO L2A 6C7 Forum disseminates content that is relevant to Postmaster: Send changes of address to members’ professional experiences, including Global Forum, 800 Enterprise Road, Suite 200, international industry and regulatory updates VOL 5 ISSUE 1 Horsham, PA 19044-3595, USA. and news of the association and its programs. The magazine is circulated six times a year as a Design: Imagevolution - 610.867.4460 benefit of DIA membership. DIA is a neutral organization that does not Publishing and Subscription: advocate for or against any issue. The views Drug Information Association (DIA), expressed by the individual authors or 800 Enterprise Road interviewees in the Global Forum are theirs and Suite 200, Horsham, PA 19044-3595, USA. do not necessarily represent the views of the Drug Information Association. Contact Information for Advertising: Mike Boucher Influence Media Director, Client Publishing Services The DIA Global Forum 267-419-8735 CONTENTS EUROPE Report on the DIA Europe Training Course 57 Amsterdam On-Location 59 Jenny Kimbel EuroMeeting Themes Drive the Debate in Medicines Development 65 Robin Gallon CHINA DIA China Successfully Held ICH Pharmacovigilance Training 71 Cocktail Therapy: Victory in Just One Battle 73 Donglei Mao HSA & MEB Sign MOU at Asia Regulatory Conference 2013 76 JAPAN 9th Japan Annual Meeting Reflections 77 Junichi Nishino INDIA Association NEWS 100 Gene Based Therapies: DIA is pleased to announce Ethical Challenges in India 80 Stephen P. Spielberg, MD, PhD, 3 Arun D. Bhatt former FDA Deputy Commissioner for Medical Products & Tobacco, EDUCATE 86 as TIRS Editor-in-Chief effective March 1 101 PROFILE Beatriz Vicén Banzo 87 FDLI Honors DIA Board Member PATIENT PERSPECTIVE Minnie Baylor-Henry 103 Cynthia Ryan, Vestibular DIA Welcomes New Disorders Association (VEDA) 89 Director of Finance/CFO 104 Karen Ball, Sturge-Weber Bayard Gardineer Foundation (SWF) 91 DIA Welcomes New Director, SIAC CORNER 94 DIA Europe 106 New SIAC for Medical Science Jytte Lyngvig Liaisons 94 GOVERNANCE CORNER Don’t Be Caught off Guard, DIA 2012-2013 Philanthropy Grants 110 Meeting Tips for DIA’s Annual Meeting 96 Members on the Move 112 Lisa Palladino Kim SIAC Name Change 98 gf GLOBAL FORUM OPEN FORUM Innovations in DIA Publications and Regulatory Science The New Year has brought with The other previously announced it a change in DIA publications, change, the members would have which affect the Global Forum and already seen when they received other communication sources. the paper copy of Therapeutic Those members that read the Innovation & Regulatory Science electronic version of Global Forum (TIRS), a replacement of the 4 will not notice and will not be Drug Information Journal that surprised by the disappearance has been with us for over 40 of our paper edition. The change years. It is a continuation of DIA to a paperless version has been scientific publishing, but it is also announced on the title page of a reflection of a change in focus VOL 5 ISSUE 1 the last several issues of 2012. and adjustment to the current and This move will be accompanied future needs of membership. It is by a better access to the forum a welcome modification of the DIA ANDRZEJ content via other electronic media, publication focus, which creates a e.g. a tablet, android,etc. With this solid foundation for the provision CZARNECKI change we have reached the end of information and communication of an era during which many of us to the outside world in years to kept copies of issues of GF on the come. shelf for future reference on many topics, which this publication This issue’s Special Topic in the has covered in the Special Topic INFORM section has been put section over the last 4 years. together, just as in the previous From now on the ‘shelf’ will be issues, by Jean Soul-Lawton (Big on the DIA website or in a form ‘Thank you’ to Jean from the of personal electronic storage. Editorial Board, myself and the readers). It provides a second part of the update on ‘Emerging Markets.’ The majority of articles cover the conduct of clinical trials in several ‘emerging’ countries. Those readers that remember the implementation of GCP, and where and how CTs were conducted some 25 years ago, and since views on outcomes of regulatory then, can only admire how big decisions. With a much clearer a change ‘emerging’ countries understanding of fast evolving Global Forum have gone through during these science and regulatory science, past few decades. This section we may see a much more positive Editorial Board also includes
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