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date_range January 23, 2025
⏰ Webinar Time: 14:00 – 15:00 (UTC+1, CET)
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08:30 – 10:00 (UTC+8, SGT)
13:30 – 15:00 (UTC+10:30, ACDT)
CIOMS Real-world data report 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.
About the event
- mic 5 Speakers
- group 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
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Lembit Rägo
Secretary-General, CIOMS, Switzerland
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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
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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
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Sean Hennessy
Professor of Epidemiology and of Systems Pharmacology and Translational Therapeutics / Director, Division of Epidemiology, Perelman School of Medicine, University of Pennsylvania, US
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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
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David Shaw
Institute for Biomedical Ethics at the University of Basel, Switzerland, and Associate Professor of Health Ethics & Law, Maastricht University, the Netherlands
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Juhaeri Juhaeri
Vice President and Global Head, Epidemiology and Benefit-Risk, Sanofi, US
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Elodie Baumfeld Andre
Head of Real-World Data (RWD) team, Roche Information Solutions, US
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Alar Irs
Chief Medical Officer, State Agency of Medicines, Estonia
Webinar programme
schedule All times shown in CET (Central European Time, UTC+1)
Regulatory context
Lembit Rägo
Data sources
Juhaeri Juhaeri
Methods
Yoshiko Atsuta
Ethics and governance
David Townend
Conclusion
Sean Hennessy