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Session 5: Building Quality into Effective Implementation of Communications with Payers
Session Chair(s)
Michele Sharp, PharmD
Senior Director, Global Regulatory Affairs
Eli Lilly and Company, United States
This session will discuss industry considerations on how to build a quality process to support payer communications prior to product approval and promotional communications with robust healthcare economic information following product approval. A discussion will happen on the implications of the FDA Guidance on Communication with Payers, Formulary Committees, and Similar Entities on company standards and processes.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss the impact of FDA Guidance on healthcare economic research efforts
- Identify components of quality system in development and approval of communications with payers
- Describe key principles of effective implementation to deliver compliant communications
Speaker(s)
Panelists:
Kate Robinson
Merck, United States
Executive Director, Integrated Account Management, Strategic Insights
Panelists:
Bryan M. Johnstone
Sanofi-aventis U.S., United States
Vice President, Evidence Based Medicine
Panelists:
Rose Berardi-Mckenna, MSc
Bristol-Myers Squibb, United States
Counsel and Associate Director, Commercial Regulatory Affairs
Panelists:
Jen DeCamara
Johnson & Johnson, United States
VP Law, US Pharmaceutical Strategic Customer Group