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Sunday, June 26 • 1:00pm - 4:30pm
#31: Preparing for a US FDA Advisory Committee Meeting

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Limited Capacity seats available

Component Type: Tutorial
CE: ACPE 3.25 Application UAN: 0286-0000-16-511-L04-P; CME 3.25; IACET 3.25; RN 3.25

An additional registration fee is required for all preconference tutorials. Register today for this tutorial.

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 tutorial teaches best practices for preparing for an FDA Advisory Committee meeting, and it is set up like an actual Advisory Committee meeting.

What You Will Learn:
• What is an advisory committee?
• What does an advisory committee “look like”?
• 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 tutorial is designed for professionals in regulatory affairs, clinical research leads, and corporate executives.

Learning Objectives

• Identify the critical factors in preparing for a successful advisory committee meeting;
• Recognize and evaluate those factors that are most applicable to your team;
• Design the most effective preparation for your team(s).


Speakers
avatar for Kaia Agarwal

Kaia Agarwal

Independent Regulatory Consultant, PharmApprove
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 27 years she has led several teams to develop products in all major therapeutic areas, especially in preparation for agency meetings including CHMP Scientific advice, FDA... Read More →
avatar for Lisa Peluso

Lisa Peluso

Director, Coaching and Client Engagement, PharmApprove, a member of the NDA Group
Lisa Peluso is a Communications Coach at PharmApprove, where she works with development teams to create and deliver clear, consistent, and convincing messages to regulators in the US and Europe. Lisa has coached individuals and provided presentation/Q&A training and workshops to teams in pharma and biotech, and has helped over 30 clinical development teams prepare for FDA Advisory Committee meetings. Prior to joining PharmApprove, Lisa worked... Read More →


Sunday June 26, 2016 1:00pm - 4:30pm
103A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA