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FDA Advisory Committee Strategy Summit 2018

November 5, 2018 @ 8:00 am - November 6, 2018 @ 3:15 pm

 

 

At ExL Events’ FDA Advisory Committee Strategy Summit, convening November 5–6, you will learn from experienced and successful AdCom members, Industry Representatives, and the FDA on how to define your team’s core presentations, establish key messaging, uncover the backgrounds of FDA Advisory Committee members, and examine the overall Advisory Committee process.

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.

 

Featured Sessions

Aden Asefa, MPH, Regulatory Health Project Manager at the U.S. Food and Drug Administration, will address panel member preparation and the expectations from the FDA and industry, as well as provide recent examples of FDA decisions that were based on recommendations from panel meetings.

Dr. Elizabeth Garner, Chief Medical Officer and Senior Vice President of Clinical Development at Agile Therapeutics, will assist your team to prepare their content and apply the scientific messaging needed to explain your products’ story.

Elijah Wreh, Regulatory Affairs Manager at Invacare Corporation; and Industry Representative at the FDA Advisory Committee Neurological Devices Panel, will examine the FDA Advisory Committee selection process to understand the backgrounds of Advisory Committee members.

 

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

 

 

Don’t miss this must-attend event — be sure to save your seat today! Register before Friday, September 21 to save $200. Please mention Priority Code 797918EM7 when checking out.

 

 

Venue

Hilton Washington Dulles Airport
13869 Park Center Road
Herndon, VA 20171 United States
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Organizer

ExL Events
Phone:
For information on speaking opportunities, please contact Warren Drysdale at wdrysdale@exlevents.com or 917-258-5162.
Email:
For information on sponsorship or exhibition opportunities, please contact Jayson Mercado at jmercado@exlevents.com or 212-400-6236.
Website:
http://exlevents.com