MHRA Good Manufacturing Practice Symposium 2023
...focussed one-day in-person event in London, while opening the event to a significant number of additional delegates online. I was honoured to chair the day’s events and have the best...
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Regulator’s experience of clinical trials during the Covid-19 pandemic (Part 2) – what we have learned
Posted by:
Gail Francis, Martin O'Kane, Kirsty Wydenbach and Lisa Campbell, Posted on:
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Categories:
Good clinical practice, Inside the Inspectorate
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....
GCP Inspections: Expectations and the dos and don’ts for hosting
...any. Reflect on who is going to be essential for hosting the inspection and determine which office location is going to work best. Discuss this with your Lead Inspector. DON’T:...
Operational Transformation Programme – an Inspectorate view
...operations to maximise public health impact and to optimise our role in the health system. The objective is to ensure services are delivered in a way that demonstrates best value...
Who inspects the Inspectors? (Part II)
Posted by:
Ian Jackson, Posted on:
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Categories:
Compliance matters, Good clinical practice, Good distribution practice, Good laboratory practice, Good manufacturing practice, Good pharmacovigilance practice, Inside the Inspectorate, Wider MHRA
...agreed in the following areas: Management systems; Assessment of marketing authorisation applications; Pharmacovigilance (drug safety) activities; and Inspection services. The assessment is an opportunity to identify strengths and best practices...
MHRA Pharmacovigilance Symposium 2018
Posted by:
Mandeep Rai, Posted on:
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Categories:
Compliance matters, Events and symposia, Good pharmacovigilance practice
...keep in mind when outsourcing pharmacovigilance activities to service providers. Anna talked about assessing the suitability of service providers, as well as mechanisms for oversight of outsourced activities, and considerations...
Public Consultation on new Clinical Trials Legislation
Posted by:
Gail Francis and Martin O'Kane, Posted on:
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Categories:
Events and symposia, Good clinical practice
...lives: the future of UK clinical research delivery, a key theme of which is to deliver streamlined, efficient and innovative research – so the UK is seen as the best...
Advice for Management of Clinical trials in relation to Coronavirus
Posted by:
Gail Francis and Kirsty Wydenbach, Posted on:
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Categories:
Compliance matters, Good clinical practice
...and a Sponsor and Investigator should not forget they are able to use Urgent Safety Measures, or even temporarily halt a trial, or halt recruitment, if this is the best...
We’re Hiring - meet some of the Inspectors in Compliance Team 1
Posted by:
Mandy Budwal-Jagait, Posted on:
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Categories:
Compliance matters, Inside the Inspectorate, recruitment
...I was one of them too. Applying and saying yes to the role, was the best decision in my career so far. This is a role of public service and...
Refrigerated medicinal products, part 1: receipt and storage - some things to consider
Posted by:
Steve Todd, Posted on:
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Categories:
Compliance matters, Good distribution practice, Good manufacturing practice
...this blog… refrigerators - best practice Whatever type of refrigerator or cold store is used, once a mapping exercise has taken place, products should be stored in an orderly fashion...
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