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
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
Stephanie Krogmeier, Ph.D.
Sr. Director, Regulatory Affairs CMC