FDA Advisory Committees Strategy Summit

Memo

Preparation for the FDA Advisory Committee is a process that should parallel product development. Since there has already been significant time and money invested in to develop the product in a review, manufacturers must be able to support their product in this highly visible, high-stakes public meeting. One of the most challenging experiences for any team to experience is appearing before an FDA Advisory Committee, which is why it is important to be prepared for all and any questions regarding the product in review. At ExL’s FDA Advisory Committees Strategy Summit, you will receive a better understanding of how to enhance the Likelihood of a Successful Panel Meeting with the FDA through strategic planning. Key event takeaways1 - Navigate Advisory Committee preparation from a safety and pharmacovigilance standpoint2 - Understand the roles of Advisory Committee membership types3 - Set the stage for a successful launch with practical models of preparation4 - Instill best practices for regulatory submissions5 - Adhere to regulatory updates and standards