FDA Advisory Committees Strategy Summit – FDA Advisory Committees Strategy Summit
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.
Top Five Reasons to Attend
- Navigate the FDA Advisory Committee selection process
- Understand the roles of Advisory Committee membership types
- Set the stage for a successful launch with practical models of preparation
- Instill best practices for regulatory submissions
- Adhere to regulatory updates and standards
Who Should Attend
Primary Audience —
- Regulatory Affairs
- Regulatory Submissions
- Regulatory Operations
- Regulatory Compliance
- Regulatory/Medical/Clinical/Technical Writing
- Medical and Clinical Affairs
- Clinical Development
- Clinical Operations
- Clinical Research Lead
- Safety/Product Safety/Drug Safety
- Product Development
- Pharmacovigilance
- Biostatistics
- Legal/Counsel
- Corporate Executives
Secondary Audience —
- Consultants
- Technology Vendors