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ON DEMAND - Demystifying Global Device Requirements: High Level Comparison of Current Expectations
Session Chair(s)
Celeste Frankenfeld Lamm, PhD
Senior Director, Global Regulatory Affairs – CMC
Merck Sharp & Dohme LLC , 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
Ramesh Raghavachari, PhD
FDA, United States
Chief, Branch I, DPMA1, OLDP, OPQ, CDER
Understanding Regulatory Expectations for Drug Device Products in the EU
Janine Jamieson, PhD, MPharm
International Pharmaceutical Quality (IPQ) Publications, Sweden
European Editor
Challenges in the Dossier Presentation of Combination Product Control Strategy: Integration of QbD and Design Control
Deborah M. Schachter, PhD, MBA
Janssen Research & Development, LLC, United States
Scientific Director, Dossier Development & Operations, Small Molecule Pharma Dev
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