Once a year, EMA's Methodology Working Party opens its workplan to the stakeholders whose submissions depend on it. The 2026 interested-parties meeting runs online on , 13:00–16:00 CET, covering biostatistics, modelling and simulation, pharmacogenomics, data science and AI — the quantitative-methodology side of EMA's scientific remit.
Dates and format
- Date: 4 November 2026, 13:00–16:00 CET (Amsterdam time)
- Format: online; a registration link is published on EMA's event page
- Organizer: European Medicines Agency, Methodology Working Party
- No registration fee is stated on EMA's event page as of 2 October 2026
What it covers
The Methodology Working Party sets EMA's scientific positions on the quantitative methods that run underneath drug and biologic review — statistical design, modelling and simulation, pharmacogenomics, data science and the growing use of AI in evidence generation. This meeting is the party's standing mechanism for taking input directly from industry and academic stakeholders before finalising its workplan, now running through 2028.
Who should attend
Biostatisticians and modelling-and-simulation scientists building the quantitative case inside a marketing authorisation, and regulatory affairs professionals who need visibility into where EMA's methodology thinking is heading before it lands in guidance. It is also one of the more direct open channels into how a European regulator is approaching AI-assisted evidence generation — a question every submission team now has to answer in some form.
Tracking AI in EU medicines regulation more broadly? HMA/EMA's AI & Data Forum runs the following week, and EMA's SME Info Day covers the agency's broader development-support toolkit. The full events directory lists everything we have verified.
Frequently asked questions
When is the EMA Methodology Working Party Interested Parties Meeting 2026?
Wednesday, 4 November 2026, 13:00-16:00 Amsterdam time (CET).
Is the meeting in person or online?
Online. EMA's own event page states the meeting is held online, with registration required in advance.
What does the Methodology Working Party cover?
Biostatistics, modelling and simulation, pharmacogenomics, data science, and AI as they apply to medicines regulation — the scientific-methodology side of EMA's work, distinct from product-specific review.
Is there a fee to attend?
EMA's event page does not state a registration fee; it asks interested parties to register in advance via a linked form. Confirm current terms on EMA's own event page before registering.
Who should attend this meeting?
Biostatisticians, modelling and simulation scientists, and regulatory affairs professionals whose submissions rely on quantitative or data-science methods — anyone who wants a direct line to the EMA working party that sets methodology guidance and wants its 2026-2028 workplan to reflect industry priorities.
Sources & further reading
- EMA. Methodology Working Party interested parties meeting 2026 — event page. ema.europa.eu
- EMA. Methodology Working Party Workplan 2026-2028 — Adopted. ema.europa.eu
Event details are published by the organizer and can change. This listing was corroborated via web search rather than a direct fetch of the organizer's page (network egress was blocked this session); confirm date, time, format and registration terms with EMA before making plans. Last verified 2 October 2026.
