This year, four members of our team attended the MHRA Good Practice symposium week. Part of this week were the GPvP Symposium and the joint MHRA and FDA GCP Symposium. Part of ProPharma Group’s consultants’ roles is execution of audits. For each inspectorate it is important to have the latest topics and trends and to be able to interact with international bodies such as the MHRA and FDA. During the event there were multiple opportunities to speak to inspectors where specific questions were discussed.
In summary, these were the most important topics covered at the events:
GPvP – February 11, 2020
GCP – February 13-14, 2020
Looking back at the GCP event
During the sessions, the speakers resolved doubts regarding typical inspection findings and how to avoid and resolve them. As an example, it was mentioned that it is expected that clinical trial protocols will define the sources of data that confirm the trial subjects’ eligibility criteria. That is, not only add in the clinical history that the patient meets the criteria. Another example relates to the trial oversight of the sponsor: for which inspectors do not only expect minutes of the meetings to be in place, but these minutes should also have content.
We summarise the most striking findings of the event as follows:
Finally, in many topics reference to quality risk management was made. Risk-based monitoring and pro-active identification, mitigation and continuous monitoring of critical quality attributes are essential in clinical research nowadays and is expected to become even a bigger part in the upcoming renovation of ICH-GCP.
In general, the event was very useful, since the open questions were answered in great detail and, in most cases, with examples. The point of view of the inspectors of both agencies is very interesting, since it facilitates the work of the pharma industry during their own audits, which is highly recommended.