FDA Advisory Committees Strategy Summit – FDA Advisory Committees Strategy Summit

PREPARE YOUR CONTENT AND APPLY SCIENTIFIC MESSAGING
Dr. Elizabeth Garner,
Chief Medical Officer, Senior Vice President Clinical Development,
AGILE THERAPEUTICS

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
Scott Greenfeder,
Head, Oncology Regulatory Affairs Group 2,
BAYER

NAVIGATE REGULATORY UPDATES AND STANDARDS
Jack Weet,
Senior Vice President, Regulatory Affairs and Quality,
EYEPOINT PHARMACEUTICALS

PRESENT YOUR DATA
Diane Murphy, MBA,
Contractor and Former Clinical Development Director,
ALLERGAN
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





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