CIOMS Artificial Intelligence in Pharmacovigilance

place Online

date_range March 6, 2026

Artificial Intelligence in Pharmacovigilance

This webinar introduces and explains the main concepts of the CIOMS report on Artificial Intelligence in Pharmacovigilance.

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About the event

  • mic 7 Speakers
  • group 1000 Places

In December 2025, the Council for International Organizations of Medical Sciences (CIOMS) published its consensus report on Artificial Intelligence in Pharmacovigilance. This webinar introduces and explains the main concepts of the report. Artificial intelligence in pharmacovigilance addresses a rapidly emerging cross-disciplinary field that is at the intersection of pharmacovigilance, computer science, mathematics, regulation, law, medicine, human rights, psychology and social science. Consequently, just as with medicinal products, it is important to establish the approved indications, posology, side effects, and warnings and precautions for use of artificial intelligence in pharmacovigilance. The latter must be clearly defined and understood by many people from different backgrounds to propel research and practical implementation in an effective, safe and responsible manner. The diverse pool includes professionals, researchers, and decision makers working in pharmacovigilance in biopharmaceutical industry, regulatory authorities, and academia. It also includes software vendors that develop artificial intelligence solutions for pharmacovigilance, including signal management and all aspects of Individual Case Safety Report processing. This report provides the requisite terminology and conceptual understanding to actively engage in this space, either by participating in the applied scientific research and public discourse, or by performing evaluations and making decisions at your organisation.

Speakers and Panelists

  • Lembit Rägo

    Lembit Rägo

    Secretary-General, CIOMS, Switzerland

  • Elizabeth MacEntee Pileggi

    Elizabeth MacEntee Pileggi

    Senior Director, Safety Information Management and Automation, Johnson & Johnson, USA

  • Julie Durand

    Julie Durand

    Senior Pharmacovigilance Specialist, European Medicines Agency, The Netherlands

  • Niklas Norén

    Niklas Norén

    Chief Science Officer, Uppsala Monitoring Centre, the WHO Collaborating Centre for International Drug Monitoring, Sweden

  • Denny Lorenz

    Denny Lorenz

    Executive Director and Principal Consultant, Lorenz Bratti GmbH, Germany

  • Ravi Patel

    Ravi Patel

    Senior VP, Global Patient Safety & Clinical Development, USA

  • Thomas Henn

    Thomas Henn

    Director, UTEL QDirector, UTEL QPPV, Global Patient Safety, UK

  • Hua Carroll

    Hua Carroll

    Senior Director, Head of ICSR Medical Evaluation/Global Safety Officer, Biogen, USA

  • Vijay Kara

    Vijay Kara

    Director, Safety, Innovation and Analytics Group, GSK, UK

  • Benny Ling

    Benny Ling

    Scientific Reviewer, Marketed Pharmaceuticals Bureau, Health Canada, Canada

  • Walter Straus

    Walter Straus

    Vice President, Clinical Safety and Risk Management, Moderna, USA

Webinar programme

schedule All times shown in CET (Central European Time, UTC+1)

Day 2026-03-06
14:00

Welcome and introduction

Lembit Rägo

14:05

Principles, Glossary, Landscape analysis, Overview, and Regulatory aspect

Elizabeth MacEntee Pileggi

14:15

Chapters on “Risk-based approach” and “Human oversight”

Julie Durand

14:25

Chapters on “Validity & Robustness” and “Transparency”

Niklas Norén

14:35

Chapters on “Fairness & Equity”, “Data privacy”, and “Governance & Accountability”

Denny Lorenz

14:50

Chapter on “Future considerations” and Use cases

Ravi Patel and Thomas Henn

15:00

Panel discussion

Hua Carroll, Julie Durand, Thomas Henn, Vijay Kara, Benny Ling, Denny Lorenz, Elizabeth MacEntee Pileggi, Niklas Norén, Ravi Patel, Lembit Rägo and Walter Straus

Registration Information

Not-for-profit attendees

The CIOMS WG XIV webinar will be free of charge for not-for-profit attendees such as academics, employees of international organisations, and regulators. As you complete the registration form below and select your sector, you will receive a coupon code that will exempt you from payment.

How to register for free: proceed to the payment page and enter the coupon code. The coupon will reduce the registration fee to 0 CHF. CIOMS reserves the right to cancel any free registration where an individual has misrepresented their situation. Alternatively, an invoice may be sent after the webinar.

For-profit attendees

The webinar will have an entrance fee of 99.00 CHF for for-profit attendees such as employees of pharmaceutical companies, contract research organisations (CROs), technology companies and consultants. As you complete the registration form below and select your sector, payment will become obligatory.

Employees of the following pharmaceutical companies who contributed to this Working Group are eligible for free registration. If you work at one of the following companies, please use the coupon code CIOMS1401.

AbbVie, AstraZeneca, Bayer, Biogen, CSL Behring, Genentech, GSK, Johnson & Johnson, Merck KgaA, Merck Sharp & Dohme, Moderna, Pfizer, Sanofi, Takeda Development Center Americas, and United Therapeutics.

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