CIOMS Real-world data report webinar

place Online

date_range December 3, 2024

Real-world data webinar

REGISTRATION FOR THIS WEBINAR IS NOW CLOSED This webinar introduces and explains the main concepts of the CIOMS report on Real-world data and real-world evidence in regulatory decision making. https://doi.org/10.56759/kfxh6213 The webinar recording and slides will be made available after the event.

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About the event

  • mic 8 Speakers
  • group 1000 Places
  • import_contacts 1 Topic

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 will introduce and explain the main concepts of this report. 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 is intended for medicinal product regulators, healthcare payers, health care and medicinal products industries, researchers, bioethicists, patients and health care professionals. https://doi.org/10.56759/kfxh6213

Speakers and Panelists

  • Lembit Rägo

    Lembit Rägo

    Secretary-General, CIOMS, Switzerland

  • Alar Irs

    Alar Irs

    Chief Medical Officer, State Agency of Medicines, Estonia

  • Juhaeri Juhaeri

    Juhaeri Juhaeri

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

  • Yoshiko Atsuta

    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

    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

    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

    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)

  • David Shaw

    David Shaw

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

Webinar programme

Day 2024-12-03
14:00

Welcome and introduction

Lembit Rägo

14:05

Regulatory context

Alar Irs

14:20

Data sources

Juhaeri Juhaeri

14:30

Methods

Yoshiko Atsuta

14:45

Ethics and governance

David Townend

14:55

Conclusion

Sean Hennessy

15:00

Panel discussion

Anja Schiel, David Shaw

Webinar has started

Registration Closed

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