CMC CASE STUDY: BEST PRACTICES IN FDA MEETING PREPARATION STRATEGIES

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

Contact:

Brooke Akins | Manager, Market Intelligence | 312.224.1693 webinars@q1productions.com