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Disney’s Coronado Springs Resort

2024 年 03 月 06 日 7:00 上午 - 2024 年 03 月 08 日 12:30 下午

1001 West Buena Vista Drive, Lake Buena Vista, FL 32830, USA

Medical Affairs and Scientific Communications Forum

3 Tracks (Medical Communication, Medical Writing, and Field Medical) + 1 Location = A cross-functional experience for knowledge sharing, integrated thought leadership, and proactive networking.

Session 8 Track 3: Pre-Approval Information Exchange (PIE) – What Medical Affairs Should Know and Consider

Session Chair(s)

Iris  Tam, PharmD

Iris Tam, PharmD

Senior Vice President and Head, Medical Affairs and HEOR

United States

This session will review the provisions of the PIE Act, and discuss why payers need and how payers use this information. In a panel format, speakers will solicit audience responses and discuss hot topics in PIE to provide guidance and considerations for Medical Affairs professionals in the development and implementation of PIE communications.

Learning Objective : At the conclusion of this session, participants should be able to:
  • List the types of unapproved product information that can be communicated to payers
  • Identify two ways that manufacturers can communicate PIE information
  • Describe why payers need product information before FDA approval

Speaker(s)

Jeff  Lee, PharmD

Speaker

Jeff Lee, PharmD

Lumanity, United States

Vice President, Value Demonstration

Sonja  Hokett, PharmD, MS, MSc

Speaker

Sonja Hokett, PharmD, MS, MSc

BioXcel Therapeutics, United States

Executive Director, Medical Managed Care & HEOR

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