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Session 3: The (Digital) Future of CMC Submissions
Session Chair(s)
Ursula Busse, PhD, MBA
Head of Regulatory Affairs
Tigen Pharma SA, Switzerland
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 for Science, OPMA, OPQ
Dynamic Regulatory Assessment - A Paradigm Shift for Industry and Regulators
Rodrigo Palacios, MBA
F. Hoffmann-La Roche, Switzerland
Regulatory Policy Lead
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
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