EMA/ECRIN joint training session – Implementation of the Clinical Trial Regulation (EU) No 536/2014 for academia: Live demonstration of CTIS and Q&A session

Datum: 3 December 2021

Tijd: 9:00-13:00 CET

Locatie: Online

Together with EMA, ECRIN will co-host a session 3 December 2021 (9:00-13:00 CET) to support academic organisations as they look to implement CTIS. This event is developed for the ECRIN CTU community and it will include live demonstrations and Q&A to address your most pressing questions as the CTIS launch approaches. This is a free event. Registration is available to members of ECRIN CTUs.

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EMA: Training session for patients, consumers and healthcare professionals interested in EMA activities

Datum: 24 November 2021

Tijd: 9:30 -12:00 (CET)

Locatie: Virtueel

This half-day training session for representatives of patients' and consumers' and healthcare professionals' organisations aims at continuing the training session of 2020 by refreshing the regulatory pathway for medicines where stakeholders are involved. Using breakout sessions, participants will learn more about how they can contribute to scientific meetings at EMA.

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EMA Clinical Trial Information System (CTIS) webinar: dynamic demo of sponsor workspace

Datum: 21 September 2021

Locatie: Virtueel

This webinar provides a demonstration of the current status of the Clinical Trials Information System (CTIS) which is currently under development, combining presentations and discussions on the underlying principles and concepts with demonstrations of specific functionalities. After a brief introduction and overview of CTIS, the workspace functionalities that are specifically designed for use by clinical trial sponsors, including commercial and non-commercial (academic) sponsors will be demonstrated.

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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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