EMA SME Info Day “Regulatory toolbox for medicines and combined devices developers”
Dear SMEs and SME Stakeholders,
We are delighted to confirm that the SME info day titled “”Regulatory toolbox for medicines and combined devices developers” will take place on Friday, 26 October 2018 at the European Medicines Agency’s offices in London.
The latest programme can be found under the following link: Agenda
The 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.
Registration deadline: 30 June 2018
Registration for participation in person
If you wish to register for the SME info day, please complete the registration form and return by email to SME@ema.europa.eu.
Registrations will be accepted on a “first-come/first-served” basis until the registration deadline or until all places are filled. Please note that in the first instance participation is limited to one representative per registered SME. Additional participants from the same company will be placed on a waiting list. Additional places will be released closer to the event, if available, and distributed among participants on the waiting list.
Registration for participation via online webcast
Please note that registration is also needed for the online webcast. If you wish to register for the SME info day, please complete the attached registration form and return by email to SME@ema.europa.eu.
The webcast will be password protected and log in information will be provided to all registered participants shortly prior to the event.
Presentations and recordings will be published in the weeks following the event.
For further information please contact the EMA SME Office at SME@ema.europa.eu.
Corporate Stakeholders Department
Stakeholders and Communication Division
European Medicines Agency