SME info day - navigating EMA support: From innovation to marketing authorisation
Practical guidance to small and medium-sized enterprises (SMEs) across the medicines development lifecycle.
EventHumanMedicinesSME
- The original event time is:
- Friday, November 6, 2026 - 09:15 - 16:00 Amsterdam time (CET)
Date
- , -
Location
- OnlineEuropean Medicines Agency, Amsterdam, the NetherlandsLive broadcast
Event summary
EMA hosts a hybrid SME Info Day for small and medium-sized enterprises (SMEs) in the pharmaceutical sector.
The event provides practical guidance across the medicines development lifecycle, from early innovation to marketing authorisation. It helps SMEs anticipate regulatory challenges, make informed development decisions, use available support effectively and understand the implications of changes to the EU pharmaceutical framework for medicines development and 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,
- avoid common pitfalls that may lead to delays or unexpected regulatory issues.
The programme also covers the following topics:
- early interaction tools,
- EMA scientific advice,
- clinical trials in the EU and the biotech act,
- dossier preparation for marketing authorisation,
- medical devices.
In addition to EMA, contributions are also provided by the EU Innovation Network (EU-IN) and the European Commission.
Documents
Registration
Registration is open to EMA-registered SMEs and representatives of stakeholder organisations:
The event is also live broadcast. Recording and presentations are published after the event.