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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - Demystifying Global Device Requirements: High Level Comparison of Current Expectations

Session Chair(s)

Celeste  Frankenfeld Lamm, PhD

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)

Ramesh  Raghavachari, PhD

Lifecycle Considerations for Drug Device Combination Products: Scientific and Regulatory Perspectives

Ramesh Raghavachari, PhD

FDA, United States

Supervisor, Unit 3/DPQA IV/OPQA I/OPQ/CDER

Janine  Jamieson, PhD, MPharm

Understanding Regulatory Expectations for Drug Device Products in the EU

Janine Jamieson, PhD, MPharm

International Pharmaceutical Quality (IPQ) Publications, Sweden

European Editor

Deborah M. Schachter, PhD, MBA

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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