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Session 7: Medical Devices and Combination Products
Session Chair(s)
Susanne Ausborn, PhD
Global Head International Regulatory Policy
Roche, Switzerland
Ben Thompson
Vice President, CMC and Non-clinical Regulatory Affairs
GlaxoSmithKline, United Kingdom
This session will provide updates on the MDR implementation in Europe and provide an overview of the challenges in device registration and drug device combination products globally. The main objective of the session is to share industry experience with a view to enabling more efficient device registration.
Speaker(s)
MDR Updates - The Road to Implementation
Bjorg Hunter, MSc
Novo Nordisk, Denmark
Director
Global Case Studies on Challenges with Medical Devices and Combination Products
Tim Chesworth
AstraZeneca, United Kingdom
Senior Director Regulatory Affairs
Global Case Studies on Challenges with Medical Devices and Combination Products
Stephanie Horn, DrSc
F. Hoffmann La Roche Ltd., Switzerland
Technical Regulatory - Device and Combination Products
Approaches to implementing ICH Q12 for Drug/Biologic-Device Combination Products
Abhishek Telang, PhD
Merck & Co., Inc, United States
Sr. Scientist
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