WASHINGTON—Leading drug and medical device regulators from around the world will offer insight on their home countries’ and continents’ regulatory landscape during town hall sessions at the DIA 2014 50th Annual Meeting, from June 15 to 19 at the San Diego Convention Center. Regulatory innovators from the U.S., Europe, Canada and Asia will lead the discussions.
Guido Rasi, executive director of the European Medicines Agency (EMA), will chair the “Europe Town Hall” on June 17 at 10:30 a.m. This session will examine the key issues and challenges facing regulators and industry leaders in Europe, where new initiatives and entry points to facilitate regulatory procedures were recently developed. The forum will showcase what is being done to support biopharmaceutical research and development through the Innovative Medicines Initiative (IMI) in Belgium. Hans-Georg Eichler, chief medical officer of EMA, Michel Goldman, executive director of IMI, and Christa Wirthumer-Hoche, head of the Austrian Medicines and Medical Devices Agency, will join the discussion as panelists.
The “Asia Town Hall” will bring together representatives from Asian government agencies to discuss the status of pharmaceutical regulations in individual countries and the direction of international collaboration. The session, held on June 17 at 1:30 p.m., will feature insights from Tatsuya Kondo, chief executive of the Pharmaceuticals and Medical Devices Agency in Japan, and Ming-kung Yeh, director-general of the Taiwan Food and Drug Administration, will discuss trends in pharmaceutical regulations. A representative from India’s Ministry of Health and Family Welfare will provide the India regulatory update.
Kondo also will present at the “Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall,” to be held at 8 a.m. on June 17. Kondo will join additional PMDA leaders to provide a regulatory update and outline the five-year plan for Japanese drug regulation and potential challenges.
Jeffrey E. Shuren, director of the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), will examine the state of CDRH and vision for the future at the “CDRH Town Hall” on June 17 at 8 a.m. Chaired by Janet Showalter, senior regulatory group director for Genentech, a panel of experts will discuss a new FDA initiative, Case for Quality, which promotes device quality in the global marketplace.
Leslie Ball, FDA assistant commissioner for international programs, will chair the “FDA – Health Canada Regulatory Cooperation Council (RCC) Town Hall” on June 17 at 3:30 p.m. The discussion will highlight collaboration and lessons learned under the four RCC initiatives on the electronic submission gateway, common monographs for over-the-counter drugs, good manufacturing practices and veterinary drugs. It also will feature a perspective from Louise Déry, director of Health Canada’s Policy, Planning and International Affairs Directorate.
Nancy Smith, a consultant and former director of the Center for Drug Evaluation and Research (CDER) Office of Training and Communication, will chair parts one and two of the “CDER Town Hall” on June 19 at 9 a.m. and 10:45 a.m. The sessions will provide updates on regulatory changes and discuss hot topics at CDER, and feature FDA leaders including CDER’s director and deputy director of the Office of New Drugs, John Jenkins and Sandra Kweder.
ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in a neutral setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA, and regional offices covering North and South America (Horsham, Pa., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.
ABOUT DIA’s 2014 50th ANNUAL MEETING: Celebrate the Past – Invent the Future is the largest multidisciplinary event that brings together a community of life sciences professionals at all levels and across all disciplines involved in the discovery, development and life cycle management of medical products. The meeting aims to foster innovation that will lead to the development of safe and effective medical products and therapies for patients. For more information, visit www.diahome.org/dia2014.
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