A joint MHRA/HRA statement has been published which sets out the legal and ethical requirements for seeking and documenting consent using electronic methods.
Good clinical practice
Part two of this post provides two case studies from inspections where critical and major findings have been identified in regards to Organisation’s Oversight of Clinical Trials of IMP.
On the 5 and 6 September, the GCP Inspectorate held their symposium and were joined by colleagues from the FDA, the Brazilian authority ANVISA and the Israeli Ministry of Health.
The Process Licensing Office has today joined the Inspectorate to become the Inspectorate & Process Licensing Group.
The first of two posts focusing on sponsor oversight and how to improve compliance in this area.
Find out how to register for the 2018 GCP Symposium.
From 16 to 18 April 2018 the PIC/S Committee and PIC/S Executive Bureau meetings took place in Geneva, Switzerland.
The MHRA’s GXP data integrity guide has been published today.
Whilst we progress our latest recruitment campaign for GMDP Inspectors, Ian Holloway reflects on 30 years of working for the Medicines Regulator.
MHRA are actively promoting a risk proportionate approach to CTIMPs