EMA: Public stakeholder meeting on the approval and roll-out of COVID-19 vaccines in the EU

Datum: 8 January 2021

Tijd: 13:00 - 15:15 CET

Locatie: Online

EMA is organising this open event to:
> explain the basis for the approval and use of the new COVID-19 vaccines and how the safety of the vaccines will be assured;

> provide information on the roles of the European Commission and national public health authorities in the roll-out of the vaccines;

> listen to the needs, expectations and any concerns of the public and stakeholders.

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EMA: Workshop on the draft guideline on registry-based studies

Datum: 19 October 2020

Locatie: Online

This half-day virtual workshop will give an overview of the draft guideline on registry-based studies. Stakeholders will have the opportunity to discuss questions, perspectives on the usefulness of the document and recent experience on methodological aspects of registry-based studies, such as the use of a large registry for clinical trials.

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RSNN & EMA: Leveraging the value of collaboration – from regulatory science to regulatory innovation

Datum: 17 November 2020

Tijd: 13.30 - 17.30 uur

Locatie: Online

One of the main goals of regulatory science is to inform decision-making with the best evidence, and contribute to a regulatory system that is responsive to societal needs, ensures patient access to efficacious and safe medicines, adapts to scientific innovation and conducive to a fertile R&D ecosystem. In this RSNN workshop we want to explore the key regulatory science questions in the coming years, and especially address how collaborative research can be of most value for regulators, patients, companies, HTA bodies, academia and other stakeholders. Discussions with the audience, representing various backgrounds are a critical element in this respect.

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