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2020 ISPE Biopharmaceutical Manufacturing Virtual Conference


Application of ICH Q12 Principles in Modern CMC Submissions


Jun 1, 2020 12:45pm ‐ Jun 1, 2020 2:15pm

Description

This session brings together industry and regulatory agency representatives to discuss case studies involving the implementation of ICH Q12 principles in regulatory submissions to facilitate post-approval CMC changes in an efficient and predictable manner.

Moderator/Speaker(s):

Speaker(s):

  • Nina Cauchon, PhD, Director Regulatory Affairs - CMC, Amgen
  • Michael Cohen, PhD, Research Fellow - Global Chemistry, Manufacturing, and Controls, Pfizer Worldwide R&D

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