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How Can Real-World Evidence be Communicated Compliantly to Payers or Healthcare Providers?
Session Chair(s)
Ruslan Horblyuk, PhD, MA
Chief Strategic Consulting Officer
AESARA, United States
This session will discuss the discourse on how real-world data could produce real-world evidence promotional communications to inform important treatment and access decisions and would meet the evidence standards of these two available FDA Guidances.
Learning Objective : Describe how real-world evidence should be designed, analyzed, and communicated compliantly to payers or healthcare providers; Discuss ways in which real-world data and real-world evidence could meet the evidence standard for compliant communications.
Speaker(s)
Industry Perspective
Stephen Shinall, PhD
Biogen, United States
Director of Regulatory Affairs
Industry Perspective
Danny Yeh, PhD
Genentech, A Member of the Roche Group, United States
Senior Director, Health Policy and Systems Research, US Medical Affairs
Industry Perspective
Alicia Mack, PharmD
Aleysheya, LLC | and AESARA, United States
Founder | and AESARA Consulting Partner
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