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The regulatory profession encompasses a wide range of professional titles and job responsibilities related to ensuring that healthcare products in areas such as medical devices, biologics and pharmaceuticals are safe and effective and comply with all applicable government regulations. The 2008 RAPS Annual Conference & Exhibition, the theme of which is "Leadership in Motion," will take place at Boston's Hynes Convention Center, 14-17 September.
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"This is a very exciting time to be in the healthcare product regulatory profession as the profession continues to grow in its influence and recognition," said RAPS Executive Director Sherry Keramidas, PhD, CAE. "From research and development though clinical trials, marketing and product surveillance, regulatory professionals play important roles at every stage. With the rapid pace of new medical and healthcare technology, the changing global regulatory landscape and the increased attention to the role that regulatory concerns play throughout the healthcare product lifecycle, this year's RAPS Annual Conference & Exhibition promises to be an important one to watch for anyone concerned with developing and disseminating life-saving and life-enhancing products."
Among the topics to be examined at the conference are safety issues in clinical trials; the evolving regulatory environment in China, India, Southeast Asia and other emerging regions, and the impact on the global healthcare product market; postmarket clinical registries; drug anti-counterfeiting strategies; environmental regulations' impact on drug development; and pediatric drug development. The overarching theme of leadership will be discussed at sessions throughout the conference.
Senior officials from the US Food and Drug Administration (FDA), the European Medicines Agency (EMEA) and other top regulators will update attendees on the latest developments from their respective agencies. Attendees also will hear from prominent keynote speakers in medicine, media and business.
Following are some conference highlights. For more information and a complete listing of conference events, visit www.raps.org/ac2008.
Monday, 15 September
8:30-10:00 am
Keynote: Dr. Atul Gawande, practicing surgeon, writer and best-selling author
11:00 am-12:00 pm
Regulatory Hot Topics Overview: Asia
Overview of the diverse, rapidly evolving regulatory structure and processes of China, India and Southeast Asia.
Tuesday, 16 September
8:30-10:00 am
Keynote: Dr. Joseph L. Bower, Baker Foundation Professor, Harvard Business School
11:00 am-12:00 pm
Seeking Balance: Regulation, Innovation and Cost-Containment of Orphan Biopharmaceuticals
Examination of the current regulatory landscape of orphan drugs from both US and EU perspectives.
1:30-3:00 pm
Postmarket Clinical Registries
Usage of clinical registries has increased, providing more information for postmarket surveillance and altering expectations for medical devices.
3:30-5:00 pm
Emerging Safety Issues in Clinical Trials
Recent drug recalls and media coverage of safety concerns have heightened the political climate in which regulators operate. What are the emerging safety issues in clinical trials?
Product Testing and China's Regulatory Environment
Regulations for medical devices in China are evolving continuously. Sp
