RAPS Twin Cities Chapter: FDA Advisory Committee 101: The Basics

Is your company developing a first-of-a-kind or first-in-class product? Are there challenges or complexities to your data? Is your submission controversial or of public interest in any way? If so, an FDA advisory committee may be in your future.

FDA's advisory committees usually have only one day to provide independent expert advice to the Agency on a range of complex scientific, technical and policy issues. Since the Agency normally follows their advice, for sponsors, an FDA Advisory Committee is the wrong time for an original thought.

During this dynamic session, you will learn what an advisory committee is and why early preparation is key. There are critical components in preparing for this public regulatory meeting, such as:

  • the development of a 45-90 minute company presentation
  • the submission of a thorough, yet concise, briefing document
  • the need to respond to important questions from a diverse group of panel members

This event is coordinated by the RAPS Twin Cities Chapter and is intended to encourage knowledge sharing and community development. Dinner will be provided. RAC holders may claim two RAC recertification credits.

 Contact RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org to learn about the special student registration rate.




  • At a Glance
  • Objectives & Audience
  • Agenda
  • Speaker
  • Registration Info
  • Cancellation

At a Glance

Date:

Wednesday, 29 March 2017 (5:30–8:30 pm CDT) 

Location:

Saint Cloud State University at Plymouth
9750 Rockford Road
Plymouth, MN 55442

Directions are available online or by calling +1 320 308 6000.

RAC Credits:2 RAC certification credits upon completion of the program 

Registration Fees:

Prior to 22 March 2017:
RAPS members: $30
List: $45

On or after 22 March 2017:
RAPS members: $40
List: $55

 

Contact RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org to learn about the special student registration rate.

Objectives & Audience

At the conclusion of this program, you will have a better understanding of:

  • What FDA advisory committees are, how they are run and why they are convened
  • When products are most likely to go to an advisory committee
  • The preparation process leading up to an advisory committee
  • The implications an advisory committee may have on your products and company

Agenda

Wednesday, 29 March 2017 (5:30–8:30 pm CDT)

5:30–6:15 pm            Registration Check-in, Networking and Dinner

6:15–6:45 pm            Activity and Chapter Business

6:45–8:30 pm            Speaking Presentation and Q/A Session

Speaker

Chris Mullin, 3D Communications

Registration Info

Prior to 22 March 2017:
RAPS members: $30
List: $45

On or after 22 March 2017:
RAPS members: $40
List: $55

Contact RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org to learn about the special student registration rate.

>> Registration Online

>> Registration Form (PDF) – for registration by mail or fax.

Other Information

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.

Questions? Call RAPS Solutions Center at +1 301 770 2920, ext. 200, or email raps@raps.org.

Program Contact

Local Contact: Lena Cordie, chair, RAPS Twin Cities Chapter

RAPS contact: Wesley Carr, senior program manager, chapter and volunteer relations, RAPS 

 

 

 

 

Cancellation

RAPS is not able to accept cancellations by phone. All requests for cancellation must be received in writing or by calling customer service. Supporting documentation is required and must be received by the deadline specified. Chapter events with registration fees less than $100 will not be refunded. For events that exceed this amount a 20% cancellation fees will be assessed.

Please send your cancellation information, with documentation, specifying the name of the person registered, customer (or member) number and event title via email, to raps@raps.org

Substitutions may be accepted with written approval from RAPS.