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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)
Alastair Nixon
Director, Submission Publishing, GSK, United Kingdom
CMC submissions – Past, Present and Future
Norman Schmuff, PHD
, Retired, United States
Structured product quality submissions - PQ CMC
Rodrigo Palacios, MBA
Senior Director, Technical Regulatory Policy, F. Hoffmann-La Roche Ltd., Switzerland
Dynamic Regulatory Assessment - A Paradigm Shift for Industry and Regulators
Mike Abernathy
Executive Director, Global Regulatory Affairs, Amgen, United States
Leveraging Technology Through ACCUMULUS to Streamline CMC Filing and Review Activities
Dmitriy Rozdestvensky, MD, PHD
Head, Division for Coordination of Common Market for Drugs and Medical Devices F, Eurasian Economic Commission, Russian Federation
Panel discussion and Q&A, with the additional participation of:
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