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Advice for Management of Clinical trials in relation to Coronavirus
MHRA are aware that there are challenges arising in relation to Coronavirus and the effect this is having on the conduct of clinical trials. Patients may be advised to stay away from hospitals and GP...
View ArticleMHRA Guidance on Coronavirus
Following on from our previous post, further guidance has been published on our MHRA Website in relation to Managing Clinical Trials and Clinical Trial Applications. We address issues such as paperwork...
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MHRA and FDA Joint Paper 'Data Integrity in Global Clinical Trials'
Following on from the successful 2-day event in Washington in October 2018 where MHRA GCP Inspectors (Gail Francis, Steve Vinter and Andy Fisher) and US FDA joined forces to discuss data integrity,...
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Building resilience into clinical trial design and conduct during the pandemic
On 19 March, the MHRA first produced guidance for researchers on managing clinical trials of investigational medicinal products (IMPs) during the pandemic. This guidance constituted details about a...
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Reference Safety Information (RSI) for Clinical Trials- Part III
Introduction Since RSI blog posts part I and II were released, the MHRA GCP inspectorate has continued to see non-compliance in this key aspect of pharmacovigilance. Whilst additional guidance was...
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Virtual conference: The International Council for Harmonisation (ICH) E6 on...
The International Council for Harmonisation (ICH) E6 on Good Clinical Practice (GCP) is currently undergoing a major revision. ICH E6 guideline for good clinical practice is the international ethical,...
View ArticlePublic Consultation on new Clinical Trials Legislation
The MHRA has launched an 8-week public consultation on proposals for legislative changes for clinical trials. Following the UK’s exit from the European Union, the Medicines and Medical Devices Act...
View ArticleRegulator’s experience of clinical trials during the Covid-19 pandemic (Part...
The Covid-19 pandemic has been a challenging time for all of us and in this three-part blog series, we reflect on what we have learnt and how we move forward to implement those learnings for the...
View ArticleRegulator’s experience of clinical trials during the Covid-19 pandemic (Part...
In part one of this series, we explored as an introduction how we initially responded to the Covid-19 pandemic to move faster in the set-up and approval of clinical trials. Now we look at the...
View ArticleRegulators’ experience of clinical trials during the Covid-19 pandemic (Part...
In parts one and two of this series, we looked at how we responded to the unprecedented challenges the COVID-19 pandemic and the lessons we have learned. In this final part, we explore the challenges...
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