Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU
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EMA held this virtual meeting to explain the processes for the development, evaluation, approval and safety monitoring of COVID-19 vaccines in the EU, including EMA’s specific role, to all interested parties.
The meeting also gave the opportunity to the public and stakeholder groups to speak and share their needs, expectations and any concerns. This feedback will be considered by EMA and the European medicines regulatory network in the decision-making process.
Please note that some issues of high public interest, such as patient access to COVID-19 vaccines and national vaccination campaigns, lie outside EMA's remit and were not covered at this event.
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Agenda - EMA public stakeholder meeting on COVID-19 (PDF/385.85 KB)
First published: 10/12/2020
Last updated: 10/12/2020 -
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Presentation - How are COVID-19 vaccines developed? (Marco Cavaleri) (PDF/396.11 KB)
First published: 11/12/2020 -
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Presentation - EU’s regulatory process for evaluation and approval of vaccines (Fergus Sweeney) (PDF/296.77 KB)
First published: 11/12/2020 -
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Presentation - Safety monitoring of COVID-19 vaccines (Peter Arlett) (PDF/377.22 KB)
First published: 11/12/2020 -
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Presentation - Transparency, engagement and communication (Melanie Carr) (PDF/1.03 MB)
First published: 11/12/2020 -
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All applications received to speak (interventions from the application form) - EMA public stakeholder meeting on COVID-19 (PDF/452.7 KB)
First published: 06/01/2021
How are COVID-19 vaccines developed? (Presentation by Marco Cavaleri, Head of Biological Health Threats and Vaccines Strategy)
EU’s regulatory process for evaluation and approval of vaccines (Presentation by Fergus Sweeney, Head of Clinical Studies and Manufacturing)
Safety monitoring of COVID-19 vaccines (Presentation by Peter Arlett, Head of Data Analytics and Methods)
Transparency, engagement and communication (Presentation by Melanie Carr, Head of Stakeholders and Communication)