A link to the newly published ICMRA paper, which provides a valuable insight into how global regulators have managed regulatory oversight, inspections and assessments during the pandemic to support both the COVID-19 response, and also ‘business as usual’ GMP and GCP inspections.
This is the first part of a two-part blog series on the Compliance Monitor process which is being piloted by the MHRA from April 2022. The MHRA has a history of implementing risk-based inspection practices: 2009: The risk-based inspection programme …
From Monday 7 to Friday 11 March 2022, the MHRA will be hosting a week-long series of events as part of the Good Practice Symposia Week. The week will include individual events from GCP, GLP and GPvP Inspectorates. Due to …
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 ahead. Remote access to EHRs …
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 unprecedented challenges we faced in …
New GMP requirements from 31 January 2022 Monday 31 January 2022 saw the Clinical Trial regulation (CTR) come into force in the European Union, and with it, the Commission guidelines on good manufacturing practice for investigational medicinal products for human …
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 benefit of the UK …
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 allows us the opportunity to update our current legislation in relation …
The MHRA GPvP Inspection Metrics report for the period April 2020 to March 2021 is now available. Read the full metrics report published on GOV.UK. We hope that the report is informative and useful for considering compliance and improvements within …
A link to the MHRA webinar of 13 August 2021 and updated information addressing some key questions received during this webinar
Members should conduct a documented review of their existing data integrity processes against the new OECD document to ensure that they fully comply and any required changes or additions are implemented.
