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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)
Denise Sanchez, JD, MA, MS
Principal Consultant, Opus Regulatory, United States
PRO-gress not Perfection: Evolution of Communicating Patient Experience in FDA Labeling and Beyond
Rohini Sen, PHD, MS
Director, Patient Experience Data & Strategy, HEOR, AbbVie, United States
Speaker
Nada A. Glavan, MPH
Executive Director, Commercial Regulatory Affairs, Eisai US, United States
Speaker
Ann Lee, PHARMD, RPH
Associate Director, Regulatory Affairs, Advertising and Promotion, Allergan Aesthetics, United States
Speaker
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