Medical Devices Global Symposium
Track:
Medical Devices, In Vitro Diagnostics, and Combination Products
Day & Time:
June 27, 9:00AM - 10:30AM
Session Number:
408
Room Number:
253C
Level:
Intermediate
Type:
Symposium
Title:
Medical Devices Global Symposium
Chair(s):
Ekopimo O. Ibia, MD,MPH,FRCP
Director and US Regulatory Policy Lead, Global Reg Strategy, Policy, and Safety
FDA Alumni Association International Network; Merck & Co., Inc., United States
Description:
The complex network of health product research, development, manufacturing and commercial distribution continues to expand globally. Different regulatory requirements must be taken into account when dealing with international development. The focus of this symposium will be to elaborate on the varying regulatory requirements with respect to the following: Specific EU rules for innovative therapies, the differences with US regulatory requirements and some clues on how to build a development plan that can support an international development; the current Chinese regulatory environment, challenges on clinical trial design, and on site and patient management; and recent efforts in the developing world (including sub-Saharan Africa) aimed at regulatory capacity as well as streamlining and strengthening regulatory processes for the regulation of medicines globally.
Learning Objective(s):
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.
Presentation(s) & Speaker(s):
EU Regulatory Requirements for Innovative Drug/Delivery System Combination Products: Comparison with US Requirements
Anne Dupraz-Poiseau
Director
Voisin Consulting Life Sciences, France
The Challenges for Designing and Conducting Clinical Trials for Medical Devices in China
Charlie Chen, PhD
Vice President
GCP Clinplus, China
Medical Devices and In Vitro Diagnostics: Capacity Building for Effective Regulation in Developing Countries
Ekopimo O. Ibia, MD,MPH,FRCP
Director and US Regulatory Policy Lead, Global Reg Strategy, Policy, and Safety
FDA Alumni Association International Network; Merck & Co., Inc., United States