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Sunday, June 18 • 1:00pm - 4:30pm
#30: Preparing for a US FDA Advisory Committee Meeting

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Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-17-503-L04-P; CME 3.25; IACET 3.25; RN 3.25

What are the critical factors when preparing for an FDA Advisory Committee meeting? Appearing before an FDA Advisory Committee can be one of the most challenging and grueling experiences for any drug, device, or biologic team. In just eight short hours with the FDA Advisory Committee, you not only must thoroughly explain but also defend, in detail, your product in a highly visible, high-stakes public meeting. This short course is structured like an actual FDA Advisory Committee meeting, and presents best practices for preparing for meetings. What You Will Learn:
  • What an advisory committee is
  • How an advisory committee is structured
  • Critical factors for advisory committee preparation
  • How to design the most applicable preparation program for your team
  • Top ten "best practices" and "must avoids"

    Who should attend?

    This course is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.

    Learning Objectives

    At the conclusion of this course, participants should be able to:
    • Identify the critical success factors in preparing for an advisory committee meeting
    • Outline those factors that are most applicable to your team
    • Design the most effective preparation strategy for your team(s)

avatar for Neelu Agrawal

Neelu Agrawal

Principal, PharmApprove, a member of the NDA Group
Neelu has over 20 years of strategic communication, cross-functional leadership and management consulting experience. Prior to PharmApprove, Neelu was a Partner at Rosetta, where she helped lead the company’s healthcare consulting practice. She has worked closely with clinical... Read More →
avatar for Pete Taft

Pete Taft

Senior Communications Coach, PharmApprove, a member of the NDA Group
Senior Communications Coach, Pete Taft provides strategic counsel and coaching services. He has conducted dozens of “lessons learned” sessions, videoconferences, workshops, seminars and individual coaching sessions. Pete began his career in journalism, covering crime, politics... Read More →

Sunday June 18, 2017 1:00pm - 4:30pm CDT
S401a McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  Short Course, Tutorial |   05: Regulatory, Tutorial
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  • Featured Topics Medical Writing
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial