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Can I Implement That Now? Efficiently Managing Post-Approval CMC Changes

Overview

During this on demand encore presentation:

We feature a recording from the DIA 2018 Global Annual Meeting.

Take on the complex problem of managing global post-approval CMC changes. Countries and regions have specific timelines for review and approval of changes, and it's not just approval we need, its approval in the right order to make implementation of the change worthwhile.

After the featured presentation hear from our experts, Peter Lassoff & Mark Wiggins.

Who should attend?

Professionals involved in:

  • CMC Regulatory Affairs
  • CMC Writing
  • Quality Assurance/Quality Control
  • Regulatory Compliance
  • API Development and Manufacturing
  • Formulation Development and Manufacturing
  • Analytical Development
  • CMC Lifecycle Management
  • CMC Project Management

Learning objectives

At the conclusion of this webinar, participants should be able to:

  • Evaluate post-approval changes differently and identify the best strategies to gain approval and implement changes rapidly

Continuing Education Credits are not available for this event.

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