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Sunday, June 23 • 9:00am - 12:30pm
SC23: #23: Preparing for a US FDA Advisory Committee Meeting

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Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-19-503-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"
An additional registration fee is required for all preconference short courses. Back to DIA 2019 Short Courses

Who should attend?

This short 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).



Speakers
avatar for Kaia Agarwal

Kaia Agarwal

Strategic Lead, PharmApprove, LLC, a member of the NDA Group
Kaia Agarwal is an independent strategic regulatory affairs consultant working with PharmApprove. She helps teams prepare and implement global regulatory strategy for their products as they prepare for critical interactions with regulators, including EMA and FDA. For over 30 years... Read More →
avatar for Lisa Peluso

Lisa Peluso

Director, Coaching and Client Engagement, PharmApprove, a member of the NDA Group
Lisa helps development teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals and provided presentation, Q&A and facilitation training to teams in pharma, and biotech, and has helped... Read More →


Sunday June 23, 2019 9:00am - 12:30pm
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA