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EMA - First certification of a veterinary vaccine platform technology master file
14th November 2024Platform technologies enable rapid response to emerging infectious disease threats
EMA - Meeting Minutes
14th November 2024PRAC, CVMP and CHMP Meeting Minutes
EMA - Public consultation - list of enabling tools
14th November 2024Comments to be provided by 30th November 2024
FDA - Draft Guidance - Integrating Randomised Controlled Trials for Drug and Biological Products Into Routine Clinical Practice
14th November 2024Submit comments by 17th December 2024
FDA - Final Guidance Conducting Clinical Trials With Decentralised Elements
14th November 2024This guidance provides recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralised elements in clinical trials.
ICH - Assembly Meeting, Montréal, Canada, November 2024
14th November 2024The 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.
ICH - Training Programme for Q8/Q9/Q10
14th November 2024This 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.
MHRA - Clinical Trials Regulations webinar recordings
14th November 2024Watch the MHRA webinar on Implementing the new UK Clinical Trials regulations, which took place on Tuesday 15 October 2024.
MHRA - Consultation on Medical Devices Regulations: Routes to market and in vitro diagnostic devices
14th November 2024The MHRA is inviting members of the public to provide their views on proposed changes to the regulatory framework for medical devices.
MHRA - views on pre-market regulations for medical devices
14th November 2024The MHRA seeks views on pre-market regulations for medical devices to improve patient access and strengthen patient safety
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