EMA: Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS

Datum: 29 July 2021

Tijd: 14:00-16:30 (CEST)

Locatie: Webinar

his informational webinar will present topics related to how sponsor organisations can prepare for CTIS. The webinar is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. Registrations for this event will open in June.

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EMA: Joint HMA/EMA workshop on artificial intelligence in medicines regulation

Datum: 19 April 2021

Tijd: 15:00-18:50 CET

Locatie: Online

Artificial intelligence (AI) and novel digital technologies hold the promise of increasing efficiency and capacity in healthcare and of providing deeper insights from big data. The HMA-EMA Joint Big Data Task Force recommended to Strengthen the Network ability in AI, which is reflected in the Big Data Steering Group work plan.
The objective of this workshop is to:
> Inform on state-of-the art use of AI in medicines with keynote presentations;
> Hear the views of stakeholders and experts on the AI actions in the Big Data Taskforce and identify any gaps.

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EMA: Joint HMA/EMA workshop on artificial intelligence in medicines regulation

Datum: 20 April 2021

Tijd: 15:00-18:50 CET

Locatie: Online

Artificial intelligence (AI) and novel digital technologies hold the promise of increasing efficiency and capacity in healthcare and of providing deeper insights from big data. The HMA-EMA Joint Big Data Task Force recommended to Strengthen the Network ability in AI, which is reflected in the Big Data Steering Group work plan.
The objective of this workshop is to:
> Inform on state-of-the art use of AI in medicines with keynote presentations;
> Hear the views of stakeholders and experts on the AI actions in the Big Data Taskforce and identify any gaps.

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EMA: Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU

Datum: 26 March 2021

Tijd: 13:00 - 15:15 (CET)

Locatie: Online

This third public meeting will provide an update to EU citizens about the continued assessment, approval and safety monitoring of COVID-19 vaccines, as well as their expected impact at community level. The event will provide participants with updated information on:

> COVID-19 vaccines approved in the EU and those currently under review;
> post-authorisation activities, including emerging safety data since EU authorisation of the first COVID-19 vaccines, and ongoing work to address new variants;
> the expected impact of COVID-19 vaccination on our society;
> transparency and the publication of clinical data for COVID-19 vaccines.

The event will also allow the public and stakeholders to further inform EMA of their needs, expectations and any concerns.

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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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