SME Info Day: Navigating EMA Support From Development to Market Authorisation

The European Medicines Agency puts its own reviewers and support staff in front of small and medium-sized enterprises for a full day — 6 November 2026 — walking through the tools and touchpoints available across the medicines development lifecycle, from first contact through marketing authorisation.

Dates and format

• Date: 6 November 2026, 09:15–16:00 CET
• Format: hybrid — in person at EMA, Amsterdam, or online via live broadcast
• Organizer: European Medicines Agency (EMA)
• Audience: EMA-registered SMEs and stakeholder-organisation representatives

What it covers

This year's SME Info Day focuses on the challenges SMEs commonly face across medicines development and how to anticipate and address them early, with practical examples and case studies. Published themes include EMA's early-interaction tools, scientific advice, running clinical trials in the EU, preparing a marketing authorisation application dossier, Health Technology Assessment, and medical devices — aimed at helping smaller companies engage effectively with EMA and the wider European medicines regulatory network and avoid pitfalls that lead to delay.

Who should attend

Regulatory affairs and clinical leads at small and medium-sized pharmaceutical and biotech companies navigating EU marketing authorisation for the first time, plus consultants and stakeholder-organisation representatives who support them. Comparing broader EU regulatory developments? EMA and HMA's Multistakeholder AI and Data Forum runs the following week, also hybrid in Amsterdam, and RAPS's PRRC Perspectives workshop covers MDR/IVDR compliance roles in December.