News Archive

EMA - Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (Rev 5)

6th August 2024

Released 26th July 2024

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EMA - Real-world evidence framework to support EU regulatory decision-making

1st August 2024

2nd report on the experience gained with regulator-led studies from February 2023 to February 2024.

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MHRA - Drug Safety Update

1st August 2024

Volume 18, 1st August 2024

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HRA - Demographic Survey Report

31st July 2024

The HRA community were asked to complete a diversity and inclusion survey.  The results help build a picture of who HRA's members are, help them understand who isn’t part of their community, and help them to take action so that members better reflect the diversity of society.

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HMA/EMA - Multi-Stakeholder Workshop on AI

24th July 2024

5th November 2024

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EMA public launch event on the guideline on good pharmacovigilance practices Module XVI on risk minimisation measures and its Addendum II

22nd July 2024

The European Medicines Agency (EMA) is hosting an online event to launch the revised guideline on good pharmacovigilance practices (GVP) Module XVI and its Addendum II. The event will provide an overview of how stakeholder comments from the public consultation on these documents have been addressed. This will be followed by a questions and answers session for answering audience questions.

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EMA - Article on RWE

19th July 2024

Co-authored by EMA and published in the Clinical Pharmacology & Therapeutics journal.

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eClinical Forum - New version of eCF Requirements and Webinar

19th July 2024

The eClinical Forum is releasing this version (V2023.3PR) as a service to the eClinical Community.

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EMA - ICH reflection paper on pursuing opportunities for harmonisation in using real-world data to generate real-world evidence, with a focus on effectiveness of medicines

9th July 2024

This reflection paper was co-developed by the European Medicines Agency, the United States of America's (USA) Food and Drug Administration (FDA), and Health Canada and adopted in June 2024 by the Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Assembly.

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EMA - Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024

9th July 2024

10 new medicines recommended for approval; another 11 medicines recommended for extension of their therapeutic indications

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