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ON DEMAND - Demystifying Global Device Requirements: High Level Comparison of Current Expectations
Session Chair(s)
Celeste Frankenfeld Lamm
Senior Director, Quality, and Global Regulatory Affairs – CMC, 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)
Lifecycle Considerations for Drug Device Combination Products: Scientific and Regulatory Perspectives
Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER, FDA, United States
Understanding Regulatory Expectations for Drug Device Products in the EU
European Editor, International Pharmaceutical Quality (IPQ) Publications, Sweden
Challenges in the Dossier Presentation of Combination Product Control Strategy: Integration of QbD and Design Control
Scientific Director, Dossier Development & Operations, Small Molecule Pharma Dev, Janssen Research & Development, LLC, United States
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