News Archive

ICH E6(R3) Annex 2 - Draft Released

15th November 2024

The draft of ICH E6(R3) Annex 2 was released by ICH EWG and is available for public consultation from today.

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EDQM Podcast

14th November 2024

Learn how the EDQM protects consumer health

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EMA - First certification of a veterinary vaccine platform technology master file

14th November 2024

Platform technologies enable rapid response to emerging infectious disease threats

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EMA - Meeting Minutes

14th November 2024

PRAC, CVMP and CHMP Meeting Minutes

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EMA - Public consultation - list of enabling tools

14th November 2024

Comments to be provided by 30th November 2024

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FDA - Draft Guidance - Integrating Randomised Controlled Trials for Drug and Biological Products Into Routine Clinical Practice

14th November 2024

Submit comments by 17th December 2024

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FDA - Final Guidance Conducting Clinical Trials With Decentralised Elements

14th November 2024

This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralised elements in clinical trials.

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ICH - Assembly Meeting, Montréal, Canada, November 2024

14th November 2024

The Assembly of the International Council for Harmonisation (ICH) met in-person on 5 & 6 November 2024, in Montréal, Canada in parallel of meetings of 11 Working Groups and 1 Discussion Group, and preceded by meetings of the ICH Management Committee (MC) and the MedDRA MC.

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ICH - Training Programme for Q8/Q9/Q10

14th November 2024

This training material is comprised of a comprehensive presentation which addresses the implementation of the three guidelines, ICH Q8(R1), ICH Q9(R1) and ICH Q10, and how they work together.

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MHRA - Clinical Trials Regulations webinar recordings

14th November 2024

Watch the MHRA webinar on Implementing the new UK Clinical Trials regulations, which took place on Tuesday 15 October 2024.

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