place Online
date_range December 3, 2024
Real-world data webinar
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
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 introduced and explained the main concepts of the report.
Presentations: Download PDF
Biographies: Download PDF
Recording Vimeo: https://www.vimeo.com/1035886886/ef81b02f5a?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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Alar Irs
Chief Medical Officer, State Agency of Medicines, Estonia
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Juhaeri Juhaeri
Vice President and Global Head, Epidemiology and Benefit-Risk, Sanofi, US
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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
Webinar programme
Welcome and introduction
Lembit Rägo
Regulatory context
Alar Irs
Data sources
Juhaeri Juhaeri
Methods
Yoshiko Atsuta
Ethics and governance
David Townend
Conclusion
Sean Hennessy
Panel discussion
Anja Schiel, David Shaw
Webinar has started
Webinar registration information
For this Webinar there is a USD 99.00 fee for participants who are employed by for-profit companies, e.g. pharmaceutical companies, CROs and consultancies.
Free registration (eligible participants)
Certain participants are eligible for free registration. If you belong to one of the following categories, please use the coupon code that has been provided to you directly by the organisers when completing the payment:
- Employees of the following pharmaceutical companies who contributed to the work of this report:
AbbVie / Bayer / Boehringer-Ingelheim / EISAI / Gilead / MSD / Pfizer / Roche / Sanofi - Participants from non-profit organisations
- Students, retired persons, or unemployed persons
How to register for free: proceed to the payment page and enter the coupon code you received from the organisers. The coupon will reduce the registration fee to USD 0.
Important: the coupon can only be used if you register with your work email address from the corresponding organisation’s domain (for example [email protected]). Registrations using personal email addresses (e.g. @gmail.com / @yahoo.com) will not be accepted for the free coupon.
CIOMS reserves the right to cancel any free registration where an individual has misrepresented their situation.
After completing the payment or coupon flow, you will see a confirmation of your registration.
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