EXAMINE THE FDA ADVISORY COMMITTEE SELECTION PROCESS TO UNDERSTAND THE BACKGROUNDS OF ADVISORY COMMITTEE MEMBERS
Regulatory Affairs Manager, Invacare Corporation and Industry Representative,
FDA ADVISORY COMMITTEE NEUROLOGICAL DEVICES PANEL
PREPARE YOUR CONTENT AND APPLY SCIENTIFIC MESSAGING
Dr. Elizabeth Garner,
Chief Medical Officer, Senior Vice President Clinical Development,
PREPARE YOUR TEAM WITH TRAINING AND TOOLS FOR SUCCESS
Michael Rozycki, Ph.D.,
Vice President, Regulatory Affairs,
PACIRA PHARMACEUTICALS, INC.
IDENTIFY YOUR AUDIENCE
Aden Asefa, MPH,
Regulatory Health Project Manager,
U.S. FOOD AND DRUG ADMINISTRATION
MASTER THE MOCK PANEL
Head, Oncology Regulatory Affairs Group 2,
NAVIGATE REGULATORY UPDATES AND STANDARDS
Vice President, Regulatory Affairs and Quality Assurance,
COLLEGIUM PHARMACEUTICAL, INC.
PRESENT YOUR DATA
Diane Murphy, MBA,
Contractor and Former Clinical Development Director,
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 Takeaways
Navigate Advisory Committee preparation from a safety and pharmacovigilance standpoint
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