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Monday, June 17 • 2:15pm - 3:15pm
#140: The State of Real-World Evidence for Regulatory Decision-Making: Views from FDA, EMA, and PMDA

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-540-L04-P; CME 1.00; RN 1.00

This session will be a panel discussion with senior leaders from FDA, EMA, and PMDA who are closely involved with real-world evidence (RWE) initiatives within their respective agencies. An open Q&A with leaders in RWE from FDA, EMA, PMDA, will be included.

Learning Objectives

Describe current perspectives of regulators from several agencies on the use of real-world evidence (RWE) for regulatory decision-making; Discuss from examples of successful use of RWE in regulatory decision-making and how they can be applied; Identify current initiatives and programs regarding RWE in each regulatory agency.

Chair

Charles Lee, MBA, MS

Speaker

FDA Update
Motiur Rahman, PhD, MPharm, MS

EMA Update
Sabine Haubenreisser, PhD, MSc

PMDA Update
Yuki Ando, PhD


Speakers
avatar for Charles Lee

Charles Lee

Executive Regulatory Science Director, AstraZeneca, United States
Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversees Global Regulatory science and strategy for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader... Read More →
avatar for Yuki Ando

Yuki Ando

Principal Senior Scientist for Biostatistics, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. She has over 20 years' experience as Biostatistics Reviewer, and currently she is responsible for the biostatistics review and consultation in the new drug and device... Read More →
avatar for Sabine Haubenreisser

Sabine Haubenreisser

Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands
Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held... Read More →
avatar for Motiur Rahman

Motiur Rahman

Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER, FDA, United States
Motiur Rahman is a Senior Epidemiologist at Real-World Evidence (RWE) Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). His responsibilities include developing guidance, improving internal Agency processes... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Forum