® 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. Worldwide Activities or the past several years, the DIA Forum and its successor, the Global F Forum, have intensifi ed their eff orts to address important issues in diff erent geographies, presenting problems on a broader scale but also on a “local” level. Global Forum Editorial Board Th is eff ort follows the association’s concept EDITOR-IN-CHIEF of working with regulators, academics, and Andrzej Czarnecki, MD, PhD, DSc industry in many countries throughout the Editor-in-Chief world. It seems that quite a lot has been achieved during that time, but there is still Richard Chamberlain, PhD a long way to go, not only due to constant ECS, Inc. development, but to a large extent due to Ronald D. Fitzmartin, PhD, MBA some rather distinctive diff erences Managing Partner ingrained in various cultures in diff erent Decision Analytics, LLC locations, many of them largely populated with a long history and culture. Th ese Betty R. Kuhnert, PhD, MBA diff erences, whether in language, history, PharmaNet well-being, fi nances, or other factors that make up everyday life, have to be Beth Lowenthal, PharmD, MBA recognized and incorporated into all Cellona Th erapeutics scientifi c and commercial activities. Over the past few years, we have published a Sarah Powell series of articles on conducting clinical Th omson Reuters ANDRZEJ CZARNECKI trials on diff erent continents. We presented issues arising from the use of many Nancy D. Smith, PhD languages, even within the same country or Potomac, MD region, emphasizing the importance of correct translations. We also drew Jean H. Soul-Lawton, DPhil attention to cultural diff erences, due in GlaxoSmithKline many cases to traditions, societal OPEN FORUM organization, history, and language. Th e Qingshan Zheng, PhD correct or incorrect understanding of these Shanghai University of diff erences has a great impact on the Chinese Medicine, China presentation and perception of informed consent, for example, as well as in the provision of any kind of information, especially in today’s high-tech climate of rapid change and progress. GLOBAL FORUM 1 We have already learned and need to remember Th e development of electronics, seen in so many of that any practices or decision making may need to our everyday tools, eg, EDC, mobile phones, social be diff erent, depending on the particular society media through Internet access, not to mention and its location. If an adjusted approach is not the “old” basic computer, has been a great help in factored in, there may be a surprising outcome or bringing people and ideas together. Today’s rapid an unexpected implication triggered by a specifi c access to information makes progress in science and activity. Th is can be diffi cult to recognize when so technology much faster than in previous decades. many individuals from all over the world cooperate It also allows individuals to understand the goals so well within the independent voluntary platform of scientifi c development of new treatments and of our association and many other platforms, and their implementation across the world, and the at the same time a broader population in a specifi c ways in which DIA continues to help by making this region may have a diff erent perception of the same knowledge globally accessible. issue or activity, be it scientifi c or commercial. For example, these situations have been experienced Over the years, we have acquired a group of readers by epidemiologists conducting important work on who follow our “Profi les” feature. Th is month’s populations in Asia, Africa, and South America profi le presents Professor Ingemar Persson, who and seeing the diversity of perceptions and enjoys a well recognized career in both the scientifi c understanding that exist in these areas. and regulatory environments. His contribution to pharmacoepidemiology has been greatly valued Th e main theme of this issue of the Global Forum for a long time, but not everyone is aware of is “Working in a Multicultural Environment.” Th e his impact on the EU regulatory environment, six articles in this section cover only some aspects specifi cally in the areas of risk management and of this broad topic, which is understandable given pharmacoepidemiology. As always for those in the limited space available in a single issue. From any DIA environment, be it regulatory, industry, this perspective, we hope to address a broader scope or scientifi c, there is something to be learned of topics of interest within this theme through from Ingemar’s professional life that could be individual articles in future issues, following our past useful to other members in their progress example. We would like to thank Betty Kuhnert, who through their work ladder. served as section editor for this group of articles. In the “Best Practices” section, the articles provide At the end of the summer, after having digested the information adding to the scope of the content of the vast amount of information delivered to us during theme, so it may be worthwhile for those interested the Annual Meeting, I hope that you will enjoy the to go through both sections at a single sitting. relaxing reading of the GF. ■ Anyone interested in contributing Call for Contributors to the content or influencing the future direction of the Global Global Forum Would you like to be a part of the ? Forum is welcome to contact the managing editor, Fran Klass, at The Global Forum is looking for individuals who are [email protected] interested in co-operating/working with the members of the Editorial Board. In addition we are looking for authors and section editors to write and/or solicit articles for our “Best Practices” section and our special focus sections. Upcoming Special Focus Sections 2010 ~ October-Informing & Involving the Patient ~ December-Health Care Policy Wrap-up 2011 ~ February-Biosimilars ~ April-Harmonization OPEN FORUM 2 GLOBAL FORUM Greetings from Around the Globe DIA Vision DIA is the global forum for knowledge exchange that fosters innovation to raise the level of health and well-being worldwide. t was genuinely an honor to be introduced as onsite and online educational programs, print DIA President during the plenary session that and digital publications, and the collaborative I opened our recent Annual Meeting in networking and information sharing from Washington, DC, especially to share the stage with which they grow, as a virtual, but non-degree and hear the insightful remarks delivered by FDA conferring, university, which now makes even Commissioner Dr. Margaret Hamburg during her more information more readily available to Keynote Address. When diff erent disciplines, more of our constituents in more areas of the educational backgrounds, professions, and world than ever before. DIA is an organization cultures, all come together in our Annual Meeting, of advanced learning and academic it is a tremendously impressive display of collective integrity, committed to the highest degree of purpose. Th ank you to all our speakers, exhibitors, transparency and ethics. Like a university, we session chairs, tutorial instructors, and, of course, are the place where the most challenging issues our program committee, beginning with Program are discussed and debated by an engaged group Chair Dr. Gaby Danan, who worked tirelessly to of current and future leaders. provide us with such a comprehensive and expansive agenda. A special section in this issue focuses on the RICHARD DAY multicultural work environment which we all I also wish to thank Dr. Jeff rey Sherman, increasingly share. I also wish to thank Dr. Betty now our Immediate Past President, not only for his Kuhnert, who served as editor for this section, kind remarks from the Annual Meeting podium and every author who contributed to this special but for his years of dedication to our association. section on our multicultural workplace. His kindness and expertise have been invaluable. As Jeff noted during his plenary remarks, this As a practicing physician, I also have the recent leadership transition represents a truly distinct privilege of experiencing first-hand historic moment in the international growth of our the benefits of our collective efforts that association, marking the fi rst Executive Committee are delivered to patients, our ultimate comprised of a DIA past president, current customers. Although we live and work president, and incoming president who represent in one common global market, patients PRESIDENT’S MESSAGE three diff erent continents: North America, the have the same needs no matter where they Asia/Pacifi c region, and Europe. DIA electing live or where we work, and we have the its fi rst President from the Australian continent same obligation to them all. The increased further illustrates how the discovery, development, participation of patient groups in our annual regulation, and marketing of biopharmaceutical EuroMeeting and Annual Meeting helps to products and devices have become truly global remind us that our vision may be global, but enterprises. we execute that vision to help individuals in need wherever they may be. ■ Th is continued global growth is important to DIA’s strategic plan and its position as a professional association.