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OFC.indd OFCI 9/25/09 6:58:38 PM Achieving Success in Drug Safety Looking to Reduce the Cost and Complexity of Safety? Request the oday, every life sciences company, large or small, is looking for ways to agOnDemand Treduce the time, cost and complexity involved in meeting their global white paper safety and pharmacovigilance obligations. A hosted service with 24x7 availability and support, agOnDemand™ delivers a fully validated, regulatory compliant, pharmacovigilance and drug safety solution Visit www.arisglobal.com/white_papers.php in as rapidly as 6 weeks. Your search is over. Now you can quickly and easily ensure domestic and global compliance while you reduce operating costs. www.arisglobal.com © 2009 Aris Global. All rights reserved. Advts.indd 2 9/25/09 11:53:42 AM The Unpredictable Impact of Change heh biggest discoveries and inventionsin of humanity were DIA Global Forum Editorial Board T ratherr simple (eg, Archimedes’ law,l theth wheel, relativity theory). It Andrzej Czarnecki, MD, PhD, DSc might have taken a very long time to Editor-in-Chief understand these simple ideas and rules at the time of their formulation and Sanjay Batra, PhD, FACC EDITOR-IN-CHIEF to put them together. However, they Johnson & Johnson clearly moved our civilization forward. Sometimes, the use of our inventions Richard Chamberlain, PhD was not clearly understood. For example, ECS, Inc. Heron of Alexandria’s steam machine worked well, but his contemporaries Ronald D. Fitzmartin, PhD, MBA could not apply it for human benefit until Daiichi Sankyo, Inc some 1600 years later. In more recent history, it took us about 30 years to start Betty R. Kuhnert, PhD, MBA benefiting from microwaves in everyday PharmaNet home use. Beth Lowenthal, PharmD, MBA Laurel, MD It may appear from our historical experience that relying on standard Sarah Powell thinking, everyday beliefs, and rules Th omson Reuters of the time has not led to too much progress. Today, when the pace of Nancy D. Smith, PhD ANDRZEJ CZARNECKI progress and information dissemination Potomac, MD is so rapid that only the few individuals who are deeply involved in the field can Jean H. Soul-Lawton, DPhil keep current with all of the changes, GlaxoSmithKline it is important to acknowledge that only appropriate simplification of Qingshan Zheng, PhD information, regulation, and application Shanghai University of OPEN FORUM can help us understand these Chinese Medicine, China developments and benefit from them. This notion seems to be frequently lost Student Member in our regulated/overregulated world/ Hina Chandawat environment. By presumption, a well Eastern Michigan University regulated (but not overregulated) world allows for better control of what is being done and how (following procedures and GLOBAL FORUM 1 OF1-Open Forum.indd 1 9/25/09 4:42:35 PM ticking boxes), but virtually eliminates ”thinking outside the box.” If such thinking is suppressed, then the dissemination of new ideas can be severely limited. To at least partially offset the impact of such a situation, one should consider the use of “think tanks,” created without any exclusion criteria in many activities of our everyday life, and specifically in those heavily regulated areas that frequently override science by legal formulae, Explore the new language, and perspective. Similar to pure science, practically all regulated areas have a substantial amount of science behind them. Excluding a frontiers in proper understanding of the science and basing judgement and decisions on the legal profession does not deliver “the right thing” to society. clinical research The impact of changes frequently cannot be predicted in full, as we have seen throughout without leaving human history. It is therefore advisable to avoid long-term, ie, unknown, consequences.Well before your office. introducing new measures, it is wise to consider the consequences of change, through think tanks, 360° feedback, or other tools to discover the most realistic prediction about the new environment. Our activities in every area are becoming more and more global, which certainly is the right direction. Therefore, a good level of thought should be given to the concept of how to move forward in research and development, control of markets and marketing, quality, and all associated activities. From an international perspective, counterfeit medicines appear to be a bigger issue for the world’s population, rather than some minor issues undergoing strict control in the three main ICH regions. Not losing sight of the latter, leading regulators from all countries should consider “merging” their brains with significant aid from scientists to more appropriately control the global market of pharmaceuticals and to diminish issues in their own areas. The availability of all drugs, whether they are branded, generic, counterfeit, or of no quality or active ingredient at all, via the Internet, should focus our thinking on the truly important aspects of safety of treatment and risk benefit for the global population. In our current issue, the Global Forum provides Buy this set of three for just $699 today. information on and from China, which is part of Simply visit http://store.centerwatch.com. our dedication to global reach and coverage. Our Print and PDF versions available. “Best Practices” section contains articles covering chosen areas of interest of our membership, so please check it to see what is there for you. This month’s profile of Jan Willem van der Laan 15th Anniversary SM presents a scientist from the Netherlands who spent most of his professional career in the 1994-2009 national and international regulatory world, 100 N. Washington St., Ste. 301 | Boston, MA 02114 OPEN FORUM helping people working in pharmaceutical sectors www.centerwatch.com on all sides of the table. ■ 2 GLOBAL FORUM OF1-Open Forum.indd 2 9/25/09 4:42:37 PM A few inches that may mean the difference between winning and losing What the regulatory authorities will consider when determining your product's efficacy – or lack thereof Advts.indd 9 9/25/09 12:01:39 PM CONTENTS Publishing Information DIA Global Forum Staff William Brassington 24 Acting Executive Director Andrzej Czarnecki, MD, PhD, DSc, Editor-in-Chief Lisa Zoks, Editor OPEN FORUM Fran Klass, Managing Editor Chris Slawecki, Senior Copywriter 1 Th e Unpredictable Impact of Change Andrzej Czarnecki Joe Krasowski, Marketing Communications Manager Pat Friia, Joyce Litwin Zimmerman PRESIDENT’S MESSAGE Freelance Writers Mission 6 Leading and Managing DIA to Continued Success The DIA Global Forum provides a multidisciplinary, Jeff Sherman neutral forum for communicating information related to drug development and lifecycle management on a global BEST PRACTICES basis. The Global Forum disseminates content that is relevant to members’ professional experiences, including 8 Fragile Bridge Between Strategy and Execution - international industry and regulatory updates and news Th e Clinical Manager in Drug Development of the association and its programs. The magazine is Peter Blaisdell circulated six times a year as a benefi t of DIA membership. Publishing, Subscription, and Advertising Offi ces: 11 Off shoring of Chemical and Pharmaceutical R&D Drug Information Association (DIA), 800 Enterprise Road toward Asia Suite 200, Horsham, PA 19044-3595, USA. Frank U. Floether Contact Information 14 Communicating Locally when Marketing Globally- Worldwide Advertising Sales, Steve Everly 267 893 5686 Subscription Information, Customer Service 215 442 6100 Th e Very Real Local Diff erences in Marketing Pharma Membership Services, Mike McGovern 215 442 6129 Products Around the World Senior Marketing Manager, Mike Keller 215 442 6173 Gary Muddyman The DIA Global Forum (ISSN: 1944-1991) is a publication of the PROFILE Drug Information Association. Editorial Offi ce: Drug Information Association (DIA), 800 Enterprise Road, Suite 200, Horsham, PA 17 Jan Willem van der Laan 19044-3595, USA; phone: 215 442 6100; fax 215 442 6199. Copyright © 2009, Drug Information Association. CAREER TIPS The DIA Global Forum (ISSN: 1944-1991) is published six times a year, in February, April, June, August, October, 19 Having Problems Getting Ahead? How to Recognize and December. Thirteen dollars of each member’s annual and Overcome Key Leadership Career Derailers membership fee is for a year’s subscription. Prices include postage and are subject to change without notice. Notify DIA REGIONAL REPORTS eight weeks in advance of address change with a copy of the mailing label. Back issues of most previously published issues China are available from DIA. PUBLICATIONS MAIL AGREEMENT NO. 41103506 23 Th e Status and Trends of Clinical Trials in China RETURN UNDELIVERABLE CANADIAN ADDRESSES TO Shimei Wen CIRCULATION DEPARTMENT, PO BOX 1051, FORT ERIE, ONTARIO L2A 6C7 24 On Location: Beijing-Imperial City to Modern Capital Postmaster: Send changes of address to DIA Global Forum, 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, 32 Interview with Ling Su USA. Periodical postage paid at Horsham, Pennsylvania, and additional mailing offi ces. 34 A Guide to Traditional Chinese Medicine Injections Cover photo: From istockphoto.com, ©Tan Kian Khoon Junchao Chen 4 GLOBAL FORUM TOC.indd 4 9/26/09 12:03:36 PM 60 35 Th e Application of Electronic Clinical Data 50 Critical Role of the CRC and Site Management in China Management in Assuring Data Quality Yinghua LV in India Dr. Sauren Das 36 Changes to China’s Patent Law Take Eff ect October 1 Latin America Tony Chen and Ann Chen 52 2nd Latin American Regulatory
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