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Boston Convention and Exhibition Center

Jun 23, 2013 8:30 AM - Jun 27, 2013 12:45 PM

415 Summer Street, , Boston, MA 02210 , USA

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science

Medical Devices Global Symposium

Session Chair(s)

Ekopimo O. Ibia, MD, MPH, FRCP

Ekopimo O. Ibia, MD, MPH, FRCP

Director, Medical Safety Review

Merck & Co., Inc; FDA Alumni Association International Network, United States

Medical Devices and In Vitro Diagnostics: Capacity Building for Effective Regulation in Developing Countries

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)

Anne  Dupraz-Poiseau

EU Regulatory Requirements for Innovative Drug/Delivery System Combination Products: Comparison with US Requirements

Anne Dupraz-Poiseau

Orchard Therapeutics, France

Chief Regulatory Officer

Charlie  Chen, PhD

The Challenges for Designing and Conducting Clinical Trials for Medical Devices in China

Charlie Chen, PhD

GCP Clinplus, China

Vice President

Ekopimo O. Ibia, MD, MPH, FRCP

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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