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 http://www.raps.org/ac2008.
Monday, 15 September
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
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.
Postmarket Clinical Registries
Usage of clinical registries has increased, providing more information for postmarket surveillance and altering expectations for medical devices.
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.
Speakers will discuss expected changes for product testing and their
potential impact on the global marketplace.
|SOURCE Regulatory Affairs Professionals Society (RAPS)|
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