News

The 51^st meeting of the GQMA (German Quality Management Association) working group GCP – Clinical Operations took place at MLM Medical Labs facilities in Mönchengladbach on Friday July 26^th.
Dr. Katja Neuer, coordinator of the working group and local host for this meeting, welcomed all participants and gave a brief overview about MLM.

Silke Kern presented the new draft from May 8^th, 2019 of the ICH-Guideline E8 (R1) which is now open for comments till September 30^th. It is the first revision of the guideline from 1997 which is also known as “General Considerations for Clinical Trials”. Silke Kern introduced the participants to the four major intentions of the guideline and provided very valuable background information about the several aspects. After having a profound overview of the intended changes and vivid discussions the working group members decided to officially comment on the new draft. Silke Kern will gather all comments of the group and pass it on to the authorities.

Another topic that was covered in an interactive group work was “Centralized Monitoring”, which has been GCP-defined in the integrated addendum ICH E6 (R2). In two different groups the advantages/chances, but also potential pitfalls and especially technical requirements were discussed. The results of the two group discussions were presented to each other and talked about in the big group. There was a big consent that the use of electronical systems plays a crucial part in centralized monitoring, but combability and usability of the different systems is one of the major challenges.

Dr. Ingo Rath, also a long-term member of the working group, gave the last talk of the day about pseudo-quality in clinical trials. He presented everyday examples of quality actions and concepts that on first sight seem to deliver a higher quality standard, but on the closer look happen to miss the actual goal of the quality control. Ingo Rath suggested that all developers and user of quality concepts should double check each new quality control with the help of root cause analysis like e.g. the 5W method. This way it can be assured that real quality is raised and not pseudo-quality.

After very intense discussions and valuable new input for their daily work the group members gathered new topics for their next meeting, which will take place on December 6th at AMS – Advanced Medical Systems in Mannheim.