News Archive

EDQM - CEP 2.0

23rd March 2023

The European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking input from Certification of suitability (CEP) users for the implementation of the CEP 2.0.

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EMA - Guideline on computerised systems and electronic data in clinical trials

22nd March 2023

This guideline replaces the 'Reflection paper on expectations for electronic source data and data transcribed to electronic data collection tools in clinical trials' (EMA/INS/GCP/454280/2010).

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MHRA - Consultation on proposals for legislative changes for clinical trials

22nd March 2023

The MHRA and the Department of Health in Northern Ireland, working closely with the HRA, consulted on a set of proposals to update, improve and strengthen the UK legislation that underpins the regulation of clinical trials. Having analysed over 2000 responses received, we will now take forward legislation to reform of the UK clinical trials regulatory framework that will: Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone Create a proportionate and flexible regulatory environment Cement the UK as a destination for international trials Provide a framework that is streamlined, agile and responsive to innovation This package of changes will deliver on our vision for a more proportionate, streamlined, flexible and effective clinical research environment, putting patients at the heart and the UK at the forefront of innovative regulation for clinical trials.

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MHRA - to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years

22nd March 2023

The legislative changes will help to make the UK one of the best countries in the world to conduct clinical research for patients and researchers.

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NHS HRA - Increasing the diversity of people taking part in research

22nd March 2023

The HRA and the MHRA are committed to enabling the highest quality health and social care research which can benefit the whole UK population. We are working together to help researchers increase the diversity of people taking part in research in the UK and we will set out our expectations in future guidance.

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ECA - A Road Map to GMP Compliant Design - The New ECA Guide

15th March 2023

The 115 page ECA Guide was launched and first published at the ECA Live Online Conference GMP-compliant Equipment Design in November 2022 - and can now be downloaded free of charge.

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EMA - CTIS Newsflash, March 2023

15th March 2023

With the aim to enhance communication with the CTIS user community, this regular CTIS newsflash provides key updates on CTIS and links to useful reference materials.

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