CIOMS Real-world data report webinar

Online

January 23, 2025

Real-world data webinar – 2nd webinar

This webinar introduced and explained the main concepts of the CIOMS report on Real-world data and real-world evidence in regulatory decision making. Due to popular demand, this is a second webinar of its kind. https://doi.org/10.56759/kfxh6213

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About the event

9 Speakers
1000 Places

In May 2024, the Council for International Organizations of Medical Sciences (CIOMS) published its much anticipated consensus report on Real-world data and real-world evidence in regulatory decision making. This webinar introduced and explained the main concepts of the report.

Presentations: Download PDF

Biographies: Download PDF

Recording Vimeo: https://vimeo.com/1051082941/c3dfdded9a?share=copy

CIOMS consensus report: https://doi.org/10.56759/kfxh6213

Real-world data — for example data from electronic health records and registries — are increasingly used to complement clinical trial data to support safety and efficacy claims for medicines. The report informs discussions about the use of real-world data and real-world evidence for regulatory and health care decision making, including decisions to make a product available for use (authorisation), to cover the costs of its use (reimbursement), and to use a product for a particular patient (clinical use). This webinar was intended for medicinal product regulators, healthcare payers, health care and medicinal products industries, researchers, bioethicists, patients and health care professionals.

Speakers and Panelists

Lembit Rägo

Secretary-General, CIOMS, Switzerland
Yoshiko Atsuta

Scientific Director, Japanese Data Center for Hematopoietic Cell Transplantation (JDCHCT), and Professor, Department of Registry Science for Transplant and Cellular Therapy, Aichi Medical University School of Medicine, Japan
David Townend

Professor of Health and Life Sciences Law and Associate Dean (Research and Enterprise), The City Law School, City St George’s, University of London, UK
Sean Hennessy

Professor of Epidemiology and of Systems Pharmacology and Translational Therapeutics / Director, Division of Epidemiology, Perelman School of Medicine, University of Pennsylvania, US
Anja Schiel

Senior Adviser, Norwegian Medical Products Agency (NOMA), Scientific Advice Working Party, European Medicines Agency (EMA) and MPG, and JSC member HTA-Coordination Group (HTA-CG), Norway
David Shaw

Institute for Biomedical Ethics at the University of Basel, Switzerland, and Associate Professor of Health Ethics & Law, Maastricht University, the Netherlands
Juhaeri Juhaeri

Vice President and Global Head, Epidemiology and Benefit-Risk, Sanofi, US
Elodie Baumfeld Andre

Head of Real-World Data (RWD) team, Roche Information Solutions, US
Alar Irs

Chief Medical Officer, State Agency of Medicines, Estonia