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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
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