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Session 5C: Drug/Device – Part 3: Global Regulatory Updates
Session Chair(s)
LeeAnn L Chambers, MS
Principal Research Scientist, Global Regulatory Affairs, CMC - Devices
Eli Lilly and Company, United States
This session will provide overviews of drug/device combination product regulations and development strategies. Topics include an update on the status of the EU Medical Device Regulations and how they will impact manufacturers, an overview of combination product development strategies for registering these products in China, and an overview of global regulation of oral liquid pharmaceutical products.
Speaker(s)
Revolution in Europe- What Changes Can You Expect Regarding Drug-Device Combinations?
Jaap Laufer, MD, PhD
Emergo, United States
VP of Clinical & Regulatory Affairs
Combination Product Development: A Harmonized Roadmap for Efficiency, Compliance, and Speed to Market in Asia
Winston R. Brown
Phillips-Medisize Corporation, United States
Vice President of Global Quality and Regulatory Affairs
Regulations and Design/Development Strategies for Oral Liquid Packaging and Device
Matthew S. Thomas
Eli Lilly and Company, United States
Packaging Design and Development Manager