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,
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

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

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
Startdate: 2018-11-05
End Date 2018-11-06

Description: The FDA Advisory Committees Strategy Summit outlines the factors that are most applicable for designing the most effective preparation strategy for getting FDA market approval.
Performer: ExL Events
Address : FDA Advisory Committees Strategy Summit