SME info day - navigating EMA support: From development to market authorisation

• Date:
  Friday, 06 November 2026 , 09:15 - 15:30 Amsterdam time (CET)
• Location:
  European Medicines Agency, Amsterdam, the Netherlands
  Live broadcast

Event summary

The European Medicines Agency (EMA) is organising a hybrid SME Info Day.

The SME Info Day is a dedicated training event designed to support small and medium sized enterprises (SMEs) active in the pharmaceutical sector throughout the medicines development lifecycle, from early innovation to market authorisation.

This year's event will focus on the challenges faced by SMEs, exploring how these can be anticipated and addressed at an early stage to ensure a smoother development and predictable authorisation. Through practical examples and case studies, the event will highlight how SMEs can effectively engage with EMA and the European medicines regulatory network, make the best use of available support tools and avoid common pitfalls that could lead to delays or unexpected regulatory issues.

The programme will cover key topics such as early interactions tools, EMA scientific advice, clinical trials in the EU, dossier preparation for a marketing authorisation, Health Technology Assessment (HTA) and medical devices. 

The event will also feature 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. Furthermore, it will also be broadcast and recorded allowing a wider audience to follow the proceedings.

Registration

Registration is by invitation only.

Video recording

A video recording will be provided after the event.