SME info day - navigating EMA support: From development to market authorisation
EventHumanMedicinesSME
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- The original event time is:
- Pátek, Listopad 6, 2026 - 09:15 - 16:00 Amsterdam time (CET)
Date
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Místo konání
- European Medicines Agency, Amsterdam, the NetherlandsLive broadcast
Event summary
The European Medicines Agency (EMA) is organising a hybrid SME Info Day to support small and medium-sized enterprises (SMEs) active in the pharmaceutical sector.
This dedicated training event provides practical guidance to SMEs across the medicines development lifecycle, from early innovation to marketing authorisation.
This year’s event focuses on the challenges commonly faced by SMEs and how these can be anticipated and addressed early to support smoother development and more predictable authorisation. Through practical examples and case studies, the event highlights how SMEs can engage effectively with EMA and the European medicines regulatory network, make best use of available support tools, and avoid common pitfalls that may lead to delays or unexpected regulatory issues.
The programme covers key topics including early interaction tools, EMA scientific advice, clinical trials in the EU and the biotech act, dossier preparation for marketing authorisation, and medical devices.
The Info Day also helps SMEs prepare for the forthcoming new pharmaceutical legislation by raising awareness of upcoming changes and supporting their understanding of the practical implications for medicines development and authorisation.
The event features contributions from the EU Innovation Network (EU-IN) and the European Commission.
The SME Info Day is open to EMA-registered SMEs and representatives of stakeholder organisations.
The event is live broadcast, and the presentations are published after the event, enabling a wider audience to follow the proceedings.