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Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
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News Archive
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
RQA - Collaboration Agreements
14th November 2024Collaboration is always high on the agenda; RQA has several initiatives in the pipeline, with many more under discussion.
FDA - Roundup - 8th November 2024
8th November 2024An at-a-glance summary of news from around the agency.
MHRA - Statement of policy intent: relaunch of the Innovative Licensing and Access Pathway
6th November 2024The Innovative Licensing and Access Pathway (ILAP) aims to get the most transformative new medicines to patients in the National Health Service (NHS) more quickly.
EMA - CTIS Newsletter - 5th November 2024
5th November 2024Latest CTIS newsletter released
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