Info day for micro, small and medium-sized enterprises (SMEs): regulatory toolbox for medicines and combined devices developers
EventHumanBrexitRegulatory and procedural guidanceSME
Date
- Friday, 26 October 2018
Location
- European Medicines Agency, Amsterdam, the Netherlands
The SME info day provides an update on regulatory affairs topics for developers of human medicines and combined devices. It covers subjects such as data exclusivity and market protection, orphan and paediatric rewards, legal basis for submission of a marketing authorisation application, conditional marketing authorisations and approvals under exceptional circumstances, classification of advanced therapies and EMA activities in relation to the new medical device legislation. An update on Brexit-related activities will also be provided at the end of the event.The 'Meet EMA' event will provide an opportunity for SMEs to engage with EMA staff from different departments to increase awareness of the range of support available at EMA.The event is open to companies that have been assigned SME status by EMA and to representatives of stakeholder organisations. It will be broadcast and recorded for interested parties to follow the proceedings.