MHRA GCP Symposium 2018


I attended the annual MHRA GCP Inspectorate Symposium which was held in the first week of September 2018. Most of the speakers were from the MHRA Inspectorate Division, but representatives from the MHRA CTU unit were also present. This symposium has gained popularity on an international level as demonstrated by the attendance of colleagues from the Brazilian authority ANVISA and the Israeli Ministry of Health. For the first time at such symposia, the MHRA GCP team were joined by 4 FDA colleagues including Jean Mulinde who provided the FDA perspective on Unblinding ‘Let me count the ways! Together they presented 22 issues: critical and major findings that compromise the integrity of blinded trials. We will be looking at these issues and address any gaps OCTRU may identify as a result of this session.
In addition to ‘Unblinding’, other topics covered included:

• Quality systems and effective CAPA (by Jason Wakelin-Smith). The CAPA was in relation to inspections, however this session was very valuable to those of us who conduct audits. There was also huge emphasis on the need for personnel to be trained and experienced appropriately for the role that they perform especially in QA.

• Computer system validation with the unique spin of how it links to football(!) (by Balall Naeem).

• A Reference Safety Information update and workshop (by Beatrice Panico from MHRA CTU and Jenny Martin).

• IMP case studies and root cause analyses (by Mandy Budwal-Jagait).

• An update on the strategic review of GCP inspections in light of new technologies in clinical trials (by Paula Walker). It looks like the MHRA may perform part of their inspections remotely from their offices, by accessing our electronic systems in a similar way to how OCTRU can access your TMFs remotely.

To emphasis their joint working with the FDA, the MHRA announced that on 23 and 24 October the FDA and The MHRA will be hosting a joint GCP Workshop titled ‘Data Integrity in Global Clinical Trials in Maryland, USA.