RAPS Philadelphia Chapter Webcast: Pitfalls to Avoid for CMC Postapproval Changes

Thursday, June 15, 2017, 12:30 PM - 2:00 PM ET

In May 2015, FDA released a draft guidance on Established Conditions.  This document provides guidance for postapproval changes and forms the basis for a risk based approach to lifecycle management. A main element of the ICH Q12 initiative is to define those established conditions where chemistry, manufacturing, and control (CMC) changes require regulatory submissions and approval.

The RAPS Philadelphia Chapter invites you to participate in a 90-minute webcast to help firms avoid problems in lifecycle management of small moleules. Topics to be covered include:

  • Assessment of CMC postapproval changes for filing requirements and supporting documentation
  • Applicable guidances to apply in different jurisdictions and interpretation of the guidances
  • Differences between jurisdictions and how these can affect product lifecycle management with real life examples of problems that have occurred
  • Appropriate filing of compendial changes—when is an annual report not appropriate
  • ICH Q12 initiative—Pharmaceutical Product Lifecycle