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News Archive

EMA clarifies Computer Validation and Data Integrity responsibilities in Clinical Trials

19th May 2020

The European Medicines Agency (EMA) has published a notice for sponsors of clinical trials (CTs) to highlight the requirements for the qualification and validation of computer systems used for managing CT data. This is based on recent inspection findings and takes into account implications on the integrity, reliability, robustness and acceptability of data. In line with this notice, the EMA has also updated questions 8 and 9 on EMA´s GCP Q&A website, which provide further guidance on computerised systems.

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Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 – update #2

19th May 2020

The International Coalition of Medicines Regulatory Authorities (ICMRA) convened a virtual meeting of regulators from around the world on 14 May 2020 to discuss high-level policy issues and regulatory requirements to respond to the ongoing COVID-19 pandemic. The strategic meeting underlined the need and commitment by global regulators to cooperate and align their approaches to clinical trial management, medicine supply issues and pharmacovigilance in light of the medical emergency presented by COVID-19.

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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 May 2020

19th May 2020

PRAC concludes review of new information on the known risk of breast cancer with hormone replacement therapy

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OECD SERIES ON PRINCIPLES OF GOOD LABORATORY PRACTICE AND COMPLIANCE MONITORING

19th May 2020

Number 21 OECD Position Paper Regarding Possible Influence of Sponsors on Conclusions of GLP Studies

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MHRA: How to manage temporary GDP process changes and risks through the COVID-19 pandemic

14th May 2020

Terry Madigan, 13th May During the Covid-19 pandemic you may need to adjust how you operate, for example using temporary process deviations and temporary staff. Such changes should be documented either as deviations, change controls or similar and incorporate quality risk management principles as described in the EU Guidelines on Good Distribution Practice for finished products.

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MHRA: Patient Support Programmes

14th May 2020

Kiernan Trevett, Posted on:7 May 2020 - Many marketing authorisation holders (MAHs) sponsor and run a wide variety of programmes that are often internally termed a ‘patient support programme’ (PSP) and we are often asked by industry about the expectations for the collection of safety data from these programmes.

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MHRA: Using personal data in your business or other organisation during and after the transition period

14th May 2020

What you should do when transferring people’s personal data between the UK and the EU/EEA.

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Safety Observer - COVID-19 Update Now Available

14th May 2020

Clinical Safety & Pharmacovigilance Regulatory Intelligence Review

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MHRA: How tests and testing kits for coronavirus (COVID-19) work

13th May 2020

The MHRA has released information for members of the public, patients, professionals and industry about COVID-19 tests and testing kits....

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COVID-19: how EMA fast-tracks development support and approval of medicines and vaccines

5th May 2020

As researchers race to develop vaccines and therapeutics against COVID-19, EMA has published an overview of how the Agency will accelerate its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible.

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