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2021 ISPE Annual Meeting & Expo

Concurrent Session: What's New from ICH?

Nov 2, 2021 4:00pm ‐ Nov 2, 2021 5:30pm


Concurrent Session: What's New from ICH?|This session features industry members from active ICH working groups providing insights on four important documents.  Three of these documents will be available for Step 2 Public Comment in the fall of 2021.  Don’t miss the opportunity to get insights from the industry experts who developed the text in the documents as you prepare to review and provide comments on ICH Q2(R2) Analytical Method Validation, ICH Q14 Analytical Method Development, and ICH Q9(R1) Quality Risk Management.  You will also hear about implementation progress on ICH Q12 Lifecycle Management including tools and enablers.

Session Leader(s):


  • Nina S. Cauchon, PhD, Director Regulatory Affairs - CMC, Amgen Inc.
  • Stephen Mahoney, Executive Director, Global Quality & Compliance, Genentech, A Member of the Roche Group
  • Andrew Chang, PhD, Vice President, Quality and Regulatory Compliance, Novo Nordisk Inc.

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