Loading…
Sunday, June 24 • 8:30am - 12:00pm
#24: Preparing for a US FDA Advisory Committee Meeting

Sign up or log in to save this to your schedule and see who's attending!

Component Type: Tutorial
CE: ACPE 3.25 Knowledge UAN: 0286-0000-18-504-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 2018 Short Courses  

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)



Speakers
MA

Martha Arnold

Principal, PharmApprove
Martha Arnold has led over 50 Advisory Committee preparation and pre-submission strategy projects at PharmApprove and possesses over 30 years’ experience in facilitating marketing and regulatory communications for pharmaceutical firms. She works closely with clinical, regulatory... 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 24, 2018 8:30am - 12:00pm
Room 160B Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  • format json
  • Credit Type ACPE, CME, IACET, RN
  • Tags Tutorial