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FDA Commissioner Margaret Hamburg, Bestselling Author Jim Collins to Keynote RAPS Annual Conference in Philadelphia
Date:8/28/2009

medical devices and myriad other healthcare products by the patients and healthcare professionals who need them every day," said RAPS Executive Director Sherry Keramidas, PhD, CAE. "It may not be thoroughly understood by the typical consumer, but these dedicated professionals are involved at every stage of healthcare product development and marketing. This conference is the premier event for regulatory professionals to gather, learn, network and hear from high-profile speakers like Dr. Hamburg and Jim Collins."

In addition to the keynote speakers, the conference will feature more than 25 additional senior FDA officials presenting at various sessions and briefings, as well as representatives from Japan's Ministry of Health Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), the Drugs Controller General of India (DCGI) and the Dutch Healthcare Inspectorate as well as many other healthcare and regulatory experts from around the world.

Among the topics to be examined at the conference are regulation of biosimilars; considerations for clinical trials of stem cell products; regulations governing counter-bioterrorism agents; health technology assessment and its relationship to comparative effectiveness research; global clinical trials; international regulatory considerations for drugs, devices, biotechnology and combination products; regulatory challenges in emerging markets; advertising and promotion; postmarket surveillance and more. Attendees also will receive briefings from representatives of FDA's Center for Devices and Radiological Health (CDRH) and Center for Drug Evaluation and Research (CDER), the European Medicines Agency (EMEA) and Health Canada.

Members of the working media wishing to cover all or part of the 2009 RAPS Annual Conference & Exhibition should contact RAPS Communications Manager Zachary Brousseau at

SOURCE Regulatory Affairs Professionals Society (RAPS)
Copyright©2009 PR Newswire.
All rights reserved

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