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Session 5: Emerging Trends for Leveraging Patient Reported Outcomes (PROs) Inclusion in Labeling and CFL Communications
Session Chair(s)
Heta Zaveri, PHARMD, MBA
Regulatory AdPromo Practice Leader
Opus Regulatory, United States
This session will provide a case study of an Exploratory PRO Inclusion in Oncology Labeling as well as discussion on leveraging CFL to communicate on PROs that may not be in labeling but are consistent with labeling. Finally, we will review recent enforcement relating to PRO promotion.
PRO-gress not Perfection: Evolution of Communicating Patient Experience in FDA Labeling and Beyond
Denise Sanchez, Opus Regulatory Inc.
Nada Glavan, Eisai US
Ann Lee, Allergan Aesthetics, AbbVie
Rohini Sen, AbbVie
Learning Objective :
At the conclusion of this session, participants should be able to:
- Identify emerging trends in the inclusion of Patient Reported Outcomes (PROs) in product labeling and corresponding CFL communications
- Discuss strategies for communicating PROs in CFL materials that align with labeling, and review recent enforcement actions related to PRO promotion
Speaker(s)
PRO-gress not Perfection: Evolution of Communicating Patient Experience in FDA Labeling and Beyond
Denise Sanchez, JD, MA, MS
Opus Regulatory, United States
Principal Consultant
Speaker
Rohini Sen, PHD, MS
AbbVie, United States
Director, Patient Experience Data & Strategy, HEOR
Speaker
Nada A. Glavan, MPH
Eisai US, United States
Executive Director, Commercial Regulatory Affairs
Speaker
Ann Lee, PHARMD, RPH
Allergan Aesthetics, United States
Associate Director, Regulatory Affairs, Advertising and Promotion
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