ACT EU Workshop: Multiplicity in Confirmatory Clinical Trials, From Two-Arm to Platform Trials

EMA's Accelerating Clinical Trials in the EU (ACT EU) initiative puts regulators, sponsors and academics in the same room — 27 November 2026 — to work through how multiplicity should shape regulatory decisions as confirmatory trial designs move from simple two-arm comparisons to adaptive platform trials.

Dates and format

• Date: 27 November 2026, 09:00–15:00 CET
• Venue: European Medicines Agency, Domenico Scarlattilaan 6, Amsterdam, with sources differing on whether attendance is primarily online or face-to-face
• Organizer: EMA's ACT EU initiative
• Audience: sponsors — pharmaceutical companies, CROs, SMEs and academic organisations

What it covers

As confirmatory trials move beyond simple two-arm comparisons toward adaptive platform designs, multiplicity — the statistical challenge of controlling error rates across multiple comparisons, arms or analyses — becomes a harder regulatory question. The workshop discusses EMA's guideline on multiplicity issues in clinical trials and its reflection paper on confirmatory platform trials, through expert talks, worked use cases and moderated discussion among sponsors, regulators and academic statisticians. It falls in the same Amsterdam stretch as HMA/EMA's Multistakeholder AI and Data Forum, two weeks earlier — both part of EMA's autumn run of stakeholder-facing methodology events.

Who should attend

Biostatisticians and clinical development leads designing confirmatory trials with EU regulators in mind, and regulatory affairs professionals at sponsor organisations preparing platform-trial strategies. EMA's own methodology and biostatistics agenda is covered in more depth at the EMA Methodology Working Party Meeting, which runs a few weeks earlier, and the full events directory lists everything we have verified.