SME info day: Regulatory toolbox for medicines and combined devices developers
|Date & Time||October 26, 2018|
|Address||30 Churchill Place
London, United Kingdom
|Location||Attendance via the broadcast|
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 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. At this moment, only attendance via the broadcast is possible. You can register until Friday, October 19 2018. You can find more information as well as the latest programme at this link.