This SME information day will provide an update on regulatory affairs topics for developers of human medicines and combined devices.
It will cover 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 activities of the European Medicines Agency (EMA) 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 staff from different EMA 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.