Back to Agenda
ON DEMAND - Demystifying Global Device Requirements: High Level Comparison of Current Expectations
Session Chair(s)
Celeste Frankenfeld Lamm
Senior Director, Global Quality and Reg CMC Policy, Merck & Co., Inc., United States
The complexity and dynamic environment of drug-device regulations can be confusing. This session will compare and contrast global regulatory expectations, as well as highlight key CMC questions as new requirements take effect.
Learning Objective : List key global regulatory agencies that review drug-device submissions and compare the high-level differences in their regulatory requirements; Describe how risk assessment is integrated into regulatory expectations for drug-device combinations; Identify the broad range of products that fit within the drug-device scope.
Speaker(s)
Ramesh Raghavachari, PhD
Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER, FDA, United States
Lifecycle Considerations for Drug Device Combination Products: Scientific and Regulatory Perspectives
Janine Jamieson, PhD, MPharm
European Editor, International Pharmaceutical Quality (IPQ) Publications, Sweden
Understanding Regulatory Expectations for Drug Device Products in the EU
Deborah M. Schachter, PhD, MBA
Scientific Director, Dossier Development & Operations, Small Molecule Pharma Dev, Janssen Research & Development, LLC, United States
Challenges in the Dossier Presentation of Combination Product Control Strategy: Integration of QbD and Design Control
Have an account?