...Trials Transformation Initiative (CTTI; a public-private partnership co-founded by the US Food and Drug Administration and Duke University in 2007). The EWG is holding 2 similar meetings on Tuesday 18...
...or being able to ‘dig around’ to see what the compliance level of a facility is really like. As Chair of the ICMRA Covid-19 working group on the Digital Transformation...
...Freedom of Information (FoI) requests on behalf of IE&S. This change forms part of the ongoing Transformation programme at MHRA and is effective from 1st August 2018. The new team...
...I am the Head of the GPvP Compliance Team. My main responsibility is the line management of the MHRA’s pharmacovigilance inspectors and to ensure the operational delivery of pharmacovigilance inspections....
...necessary systems, equipment, and procedures in place. All qualification and validation of the facility and equipment should be complete up to the point of at least operational qualification (OQ). As...
...you feel you are encountering significant operational challenges which may require additional regulatory flexibilities during the period of the COVID-19 pandemic, that you contact the MHRA GDP inspectorate. Please do...
...safety, data quality and integrity, reporting of suspected adverse drug reactions and overall protocol adherence. Most of the delegates that attended this seminar were working in an operational capacity in...
...for the Inspectorate here at MHRA. I joined the agency in 2002 after working for 10 years in the pharmaceutical industry. I’m responsible for 4 groups covering our operational activities,...
Today, 1st November 2017, the EU-FDA mutual recognition agreement (MRA) of GMP inspections of human manufacturers will start coming into force. The initial phase of the agreement starts with recognition...
...warranted. The MHRA GCP Stakeholder Engagement Meeting provides a forum for consultation and discussion around GCP and provides updates on operational, national and international regulatory matters. The format of the...
