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Real-World Evidence (RWE) for Regulatory and Health Technology Assessment (HTA) Decision Making – Where are we?
Session Chair(s)
Solange Corriol-Rohou, DrMed, MD, PhD
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
AstraZeneca , France
While the use of Real-World Data (RWD) in the post-marketing surveillance setting has increased in recent years, RWD use for decision-making in the pre-licensing is currently the focus of all stakeholders through various initiatives, including at the global level.
Learning Objective : Discuss the value and importance of various multi-stakeholder collaborations to agree what and how real-world data (RWD) can be collected in order to generate real-world evidence (RWE) to support and optimise drug development; Understand the initiatives and recommendations on the use of RWE to inform decisions by healthcare systems (HTA/payers and regulators).
Speaker(s)
Facilitator
David Sidney Ross, MBA, MSc, PMP, RAC
AstraZeneca, United States
Senior Director, Regulatory Data and Submissions
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