Pre-IND Meeting Requests and Avoiding CMC Related Clinical Hold

This webinar highlights the advantages of a pre-IND meeting request and briefing document submission for a drug development program. Learn more about what topics should be addressed and how to successfully prepare CMC and eCTD activities following regulatory requirements to increase the chance of a successful IND submission and avoid clinical hold.

Key Learning Objectives:

• Significance of pre-IND meeting requests, briefing packages, and ongoing FDA correspondence
• Successful preparation of CMC and eCTD activities per regulatory requirements
• Understanding regulatory expectations and avoiding issues