ExL Events - FDA Advisory Committees Strategy Summit

FDA Advisory Committees Strategy Summit – FDA Advisory Committees Strategy Summit

FEATURED SPEAKERS

EXAMINE THE FDA ADVISORY COMMITTEE SELECTION PROCESS TO UNDERSTAND THE BACKGROUNDS OF ADVISORY COMMITTEE MEMBERS

Elijah Wreh,
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,
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,
Vice President, Regulatory Affairs and Quality Assurance,
COLLEGIUM PHARMACEUTICAL, INC.

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.