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Session 3: The (Digital) Future of CMC Submissions
Session Chair(s)
Ursula Busse, PhD, MBA
CMC Regulatory Affairs Advisor
Self employed, France
Alastair Nixon
Director, Submission Publishing
GSK, United Kingdom
Session 3: The (Digital) Future of CMC Submissions
Speaker(s)
CMC submissions – Past, Present and Future
Alastair Nixon
GSK, United Kingdom
Director, Submission Publishing
Structured product quality submissions - PQ CMC
Norman Schmuff, PhD
FDA, United States
Associate Director, OPMA, OPQ, CDER
Dynamic Regulatory Assessment - A Paradigm Shift for Industry and Regulators
Rodrigo Palacios, MBA
F. Hoffmann-La Roche Ltd., Switzerland
Senior Director, Technical Regulatory Policy
Leveraging Technology Through ACCUMULUS to Streamline CMC Filing and Review Activities
Mike Abernathy
Amgen, United States
Executive Director, Global Regulatory Affairs
Panel discussion and Q&A, with the additional participation of:
Dmitriy Rozdestvensky, MD, PhD
Eurasian Economic Commission, Russian Federation
Head, Division for Coordination of Common Market for Drugs and Medical Devices F