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THE US GRANT, a Luxury Collection Hotel, San Diego

Nov 10, 2022 7:00 AM - Nov 11, 2022 12:30 PM

326 Broadway, San Diego, CA 92101

Real-World Evidence Conference

Translating Insights into Real-World Value

Session 3: Research and Related Initiatives to Evaluate and Improve Real-World Evidence and Real-World Data

Session Chair(s)

John  Concato, MD, MPH, MS

John Concato, MD, MPH, MS

Associate Director for Real-World Evidence Analytics, OMP, CDER

FDA, United States

Delphine  Saragoussi, MD, MSc

Delphine Saragoussi, MD, MSc

Executive Director, Real-World Evidence

PPD, part of Thermo Fisher Scientific, France

In addition to reviewing regulatory submissions, publishing guidance documents, conducting health technology assessments, and other activities, regulatory agencies and assessment organizations provide support for research and related initiatives that address knowledge gaps in seeking to improve RWD/RWE. This session will present an overview and specific examples of such efforts, some of which are described as “demonstration projects.” Specific topics to be covered include efforts to a) enhance the use and quality of RWD, b) better understand study designs that generate RWE, and c) develop tools for enabling RWD/RWE.

Part 1: Health Technology Assessment (HTA) organization perspective

Learning Objective : At the conclusion of this session, participants should be able to:
  • Recognize how regulatory agencies and health technology organizations support research and related initiatives
  • List the conceptual topics that are commonly addressed by corresponding activities
  • Describe how results obtained from these activities promote an improved drug development process


Tarry  Ahuja, DrSc, MSc


Tarry Ahuja, DrSc, MSc

CADTH, Canada

Director, Post Market Drug Evaluation (PMDE)

Daniel  Malone, PhD, RPh


Daniel Malone, PhD, RPh

Skaggs College of Pharmacy, Univeristy of Utah, United States

Professor, Department of Pharmacotherapy

Curran  Sidhu, MS


Curran Sidhu, MS

Evidera, United States

Senior Consultant, Value & Access

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