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CMC Case Study: Best Practices in FDA Meeting Preparation Strategies



 
Our Price: $395.00

Product Code: WB-7231
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About the Product
Includes 1 Hour Windows Media Video File and PowerPoint presentations for immediate download.

Throughout the drug development and product approval process, CMC ex­ecutives have a limited number of opportunities to engage with FDA to discuss areas of concern requiring clarification, making FDA meetings a pivotal opportunity. The role for CMC executives within these meetings is often ambiguous and pin pointing the essential CMC information to extract from these sessions is a common challenge. The following presentation will discuss what to anticipate from these meetings and how to con­duct the meetings in a consistent and efficient manner.
  • Ensuring CMC teams are integrated in FDA meetings
  • Timing meetings with FDA to ensure questions are clarified
  • Defining FDA expectations for pre-submission CMC data



Speaker:
Stephanie Krogmeier, Ph.D.
Sr. Director, Regulatory Affairs CMC
Vertex Pharmaceuticals


Participants that will find this webinar most beneficial will be those involved in pharmaceutical and biotechnology companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs CMC
  • Global Regulatory Affairs CMC
  • Regulatory Affairs

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