News Archive

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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FDA - Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products

9th July 2024

Draft Guidance Released

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FDA - M14 General Principles on Plan, Design, and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines

9th July 2024

Draft Guidance Released

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FDA - Updates to Guidance to Further Empower Companies to Address the Spread of Misinformation

9th July 2024

The U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health.

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HMA-EMA - 5th HMA/EMA Big Data Stakeholder Forum

9th July 2024

Announced for Thursday, 28 November 2024.

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MHRA - Procurement at MHRA

9th July 2024

MHRA have released information about procurement at the Agency and how they are improving procurement opportunities for small and medium-sized enterprises.

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