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