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.
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.
Following the February 2020 MHRA and FDA GCP symposium in London, our second joint paper is now available.
Take part in our survey and let us know what you would like to hear about at the next GPvP symposium.
Guidance for manufacturers and contract testing laboratories on the process of transferring a method for outsourcing of testing
The MHRA is inviting you to attend a free webinar as part of its commitment to providing guidance to industry and supporting stakeholders to prevent falsified medicines entering the legal supply chain.
With the move to electronic ways of working and integration of more electronic systems within a clinical trial, the MHRA GCP inspectorate has noticed that not all eSystems have been designed with the correct functionality in mind.
The ICH Management Committee is taking a unique step to provide a status update on the revisions to this guideline, via a public virtual conference on 18 and 19 May 2021. Register now.
The start of lockdown this time last year meant a complete change to the way of working for the inspectorate, with the potential to impact dramatically on our ability to maintain regulatory oversight of public health
The MHRA GPvP inspectorate recently published their latest inspection metrics for the period from April 2019 to March 2020.
All the sources of guidance published by the MHRA so far, plus further information if you still have questions.