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.
Recommendations to improve safety reporting compliance so both regulator and sponsor can fulfil their obligations to protect patients
Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 13 January 2020. This webinar was part of a series of Brexit and post-transition guidance webinars.
Post-transition: Pharmacovigilance requirements for UK authorised products webinar recording, which took place on 22 October 2020. This webinar was part of a series of EU Exit and post-transition guidance webinars.
The need for vigilance and diligence when conducting bona fide checks is integral to protecting the legal supply chain of medicines. What to look out for and how to report any suspected fraudulent activity
Updated guidance is now available to assist trial sponsors in building resilience into new and ongoing trials during the continuing pandemic.