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Session Chair(s)
Ekopimo O. Ibia, MD, MPH, FRCP
Director, Medical Safety Review
Merck & Co., Inc; FDA Alumni Association International Network, United States
Learning Objective : Describe the regulatory environment and global challenges to register and market products in China, EU, and developing countries; Identify key differences between the US regulatory framework and Europe for global medical product development.
Speaker(s)
EU Regulatory Requirements for Innovative Drug/Delivery System Combination Products: Comparison with US Requirements
Anne Dupraz-Poiseau
Orchard Therapeutics, France
Chief Regulatory Officer
The Challenges for Designing and Conducting Clinical Trials for Medical Devices in China
Charlie Chen, PHD
GCP Clinplus, China
Vice President
Medical Devices and In Vitro Diagnostics: Capacity Building for Effective Regulation in Developing Countries
Ekopimo O. Ibia, MD, MPH, FRCP
Merck & Co., Inc; FDA Alumni Association International Network, United States
Director, Medical Safety Review
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