- Posted By: Joanna Black
This year’s MHRA GCP Symposium was run on the 3rd March and attended by Joanna Black (Head of QA and RA) from OCTRU. The agenda included the following topics:
(1) Clinical Trial Approval (CTA) and the application review process: one of the MHRA’s senior pharmaceutical assessor gave an overview on the format and content of a CTA application, the assessment process (pharmaceutical, clinical and non-clinical), common errors and reason for grounds for non-acceptance and some hints and tips.
(2) Update on the implementation of the Clinical Trial Regulation and the need to have an audited portal system before the Regulation can be put in practice: this is likely to happen in late 2016. The MHRA are well represented in different workgroups to implement the regulation and ensure we have a user friendly portal. The Regulation promises for more transparency in clinical trials including the publication of serious breaches, inspection findings and the clinical trial report. The law will also enforce a summary of the clinical trial results for the lay. A significant change also includes the requirement to archive for 25 years after the end of trial. The regulation has also introduced a risk proportionate approach to the management and monitoring of clinical trials based on the current UK-MHRA guidance.
(3) A different session followed which focused on ‘Data Integrity and Computer System Validation’: the MHRA are now using definitions for data, metadata, data integrity, data lifecycle and data governance from a new document published by the MHRA in Jan 2015 entitled ‘MHRA GMP Data Integrity Definitions and Guidance for Industry’ which they are going to re-issue for all GXPs. The session was all about the governance and requirements throughout the whole lifecycle of data and computer systems.
(4) The fourth session of the day was about the management and challenges of multi-site studies and overview of studies at a site level.
(5) The fifth session was about serious breaches and the MHRA process of dealing with such breaches with a few examples.
(6) The sixth and final session was feedback from recent Inspection findings mainly in relation to the TMF, Stand-alone Investigators, Protocol non-compliances, Eligibility decisions, Change control, RSI and electronic systems/computer system validation. The symposium ended with a panel session for Q&As.
Following attendance to this MHRA symposium OCTRU will now review all its SOPs and ensure that the SOPs cover the appropriate requirements and expectations by the MHRA.