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Wednesday, June 19 • 12:30pm - 1:00pm
#333 CH: Real-World Evidence (RWE) for Regulatory and Health Technology Assessment (HTA) Decision Making – Where are we?

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Component Type: Workshop
Level: Intermediate

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 Objectives

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).

Chair

Solange Corriol-Rohou, DrMed, MD, PhD

Speaker

Facilitator
David Sidney Ross, MBA, MSc, PMP, RAC


Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French Medicines... Read More →
avatar for David Ross

David Ross

Senior Director, Regulatory Data and Submissions, AstraZeneca, United States
David Ross has led enterprise projects at AstraZeneca and Abbott Labs. He implemented enterprise solutions at AZ for cross-functional CSR Initiative, led the PQ/CMC pilot for AZ, developed roles for Early Clinical Authoring and leads Clinical Study Start up improvements in alignment... Read More →

Wednesday June 19, 2024 12:30pm - 1:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  15: Content Hubs, Workshop |   12: Value-Access, Workshop