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Pitfalls to avoid for CMC post-approval changes

October 19 @ 10:00 - 11:00 UTC+0

Webinar topic:

Pitfalls to avoid for CMC post-approval changes

Webinar date/time:

Thursday, October 19, 2017 at

10 - 11 AM EST (NYC, USA)

Webinar host:

betty-thompson

Betty Thompson -

Director, Regulatory Affairs, CMC, SRS at Mapi Group

Webinar description:

Key discussion points include -

  • Assessment of CMC post approval changes for small molecules - filing requirements and supporting documentation
  • Applicable guidances Difference between jurisdictions
  • Appropriate filing of compendial changes
  • ICH Q12 initiative - Pharmaceutical Product Lifecycle

Register to attend now:

http://webinars.mapigroup.com/cmcpostapprovalchanges