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RAPS Philadelphia Chapter Regulatory Webinar: Pitfalls to Avoid for CMC Postapproval Changes

June 15 @ 12:00 - 13:30 UTC+0

Presenting Host:

betty-thompson

Betty Thompson - Director, Regulatory Affairs - CMC, Strategic Regulatory Services, Mapi Group

Key Discussion Points:

  • Filing requirements for CMC post approval changes for small molecules for US, EU, and Canada
  • Key differences between jurisdictions and how these can affect product lifecycle management
  • Items to consider in Module 3 of a marketing application to facilitate product lifecycle management
  • Applicable post-approval CMC guidances to apply in different jurisdictions and interpretation of the guidances
  • Supporting documents requirements for post approval CMC changes for US, EU and Canada
  • How document requirements can differ between jurisdictions
  • Understanding of ICH Q12 initiative - Pharmaceutical Product Lifecycle

Register Now:

http://raps.org/EventDetail.aspx?id=27425

Details

Date:
June 15
Time:
12:00 - 13:30
Event Category:
Event Tags:
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