As FDA's top official, Dr. Hamburg is committed to strengthening programs and policies that allow the agency to carry out its mission to protect and promote the public health. She is a highly regarded expert in health and biomedical research and policy, as well as public health preparedness.
Dr. Hamburg will be joined by two other health agency leaders, Guido Rasi, executive director of the European Medicines Agency (EMA), and Paul Glover, assistant deputy minister of health products and food branch at Health Canada, during a panel discussion titled Regulatory Collaboration /21st Century Innovation: Views of the Heads of Health Canada, the European Medicines Agency, and the US FDA.
"Globalization has fundamentally changed our world and created significant challenges for those of us who are committed to ensuring the safety, quality and efficacy of medical products,” said FDA Commissioner Margaret Hamburg, M.D. “In this new world, FDA and its regulatory partners must seek new and creative ways to collaborate."
The DIA 2012 Annual Meeting will also feature a Global Regulatory Track that will bring together global regulatory agency leaders to discuss the significance of personnel and knowledge exchange among regulatory agencies, review strategy and information gained through joint projects and actions, and provide updates on activities sponsored by EMA, Health Canada, and FDA that affect products and policies in each region.
Some of the sessions within the track include:
• Center for Drug Evaluation and Research (CDER) Town Hall
• Center for Biologics Evaluation and Research (CBER) Town Hall
• European Town Hall: Parts 1 and 2
• Indian Town Hall
• International Regulatory Cooperation: A Canadian Perspective
• Latin American Town Hall
• Pediatric Drug Development Progress: 15 Years Later and Across the Globe
• Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
• State Food and Drug Administration (SFDA) Town Hall
• State of Electronic Submissions at CDER, CBER, and Center for Devices and Radiological Health (CDRH)
• Update from the EMA-FDA Parallel Assessment Pilot
• Update on EMA, FDA, and PMDA International Activities
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