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.

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

Session Chair(s)

Iris Tam, PharmD

Senior Vice President and Head, Medical Affairs and HEOR

COEUS, 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)

Speaker

Jeff Lee, PharmD

Lumanity, United States

Vice President, Value Demonstration

Speaker

Sonja Hokett, PharmD, MS, MSc

BioXcel Therapeutics, United States

Executive Director, Medical Managed Care & HEOR

Medical Affairs and Scientific Communications Forum

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

Session Chair(s)

Iris Tam, PharmD

Speaker(s)

Speaker

Speaker

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