News

The working group GCP-Clinical-Operations of the German Quality Management Association e.V. (GQMA) celebrated its 50th meeting in the brand new office buildings of X-act Cologne Clinical Research GmbH in Cologne Ossendorf on March 15, 2019.

The Cologne CRO, who will celebrate their 25^th company anniversary in May, is a specialist in clinical data management and biostatistics and from now on can offer full-service activities. X-act Cologne has provided their services for more than 400 projects, covering all phases of clinical trials.
A big thank you to X-act for hosting the working group this lovingly.

With more than 20 participants the group didn’t only celebrate its 50^th meeting with jubilee donuts, but also the 50^th birthday of one of their very active and long-term members. On behalf of the working group team leader, Dr. Katja Neuer, MLM Medical Labs GmbH, congratulated Dr. Petra Esfeld, CliPS – Clinical Project Services®. She thanked her for her long lasting assistance and honored her participation at her birthday with a bouquet of flowers.

Thank you so much Petra for being such an active member and all the best for the next years!

With two external and one internal speaker the group underwent a very comprehensive day with many new information and content for intensive discussion.

Prof. Gernot Wassmer, Professor for Biostatistics at the Institute of Medical Statistics at the University of Cologne, started the day with his presentation on adaptive trial designs. First he differentiated between three diverse adaptive trial models: Group Sequential Design, Adaptive Group Sequential Design and Confirmatory Adaptive Design and explained in detail which mathematic procedures and possible actions of intervention stand behind the three models before and during the trial. He recorded furthermore the history of the development of the adaptive trial models and gave an intensive overview about the literature over the last 25 years. After this more theoretical explanation he gave some practical advice on how to deal with the authorities when planning and applying for approval of a clinical study with an adaptive trial design.
Thank you so much Prof. Wassmer for your very professional input.

Team Member Dr. Ingo Rath, CliPS – Clinical Project Services® gave an update about the latest news from BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte), PEI (Paul Ehrlich Institut) and AmEK (Arbeitskreis medizinischer Ethik Komissionen) with regards to the BREXIT.

Furthermore he followed up on a presentation he already gave in 2017 at a working group meeting, where he explained the recommendations of the ethics committees in regard to qualification of principal investigators (Curriculum 2016) performing clinical trials. The Curriculum 2016 contains four different courses, which are only recommendations and not legally binding. In January 2019 new recommendations where compiled which should be applied in April 2019 and are more detailed and structured with the intention to standardize the courses for all federal states in Germany. Dr. Rath explained the content of the different courses in detail and exemplified the differences between AMG and MPG studies in this regard. At the end of his presentation he gave advice how the content of the training certificates for the principal investigators should look like, so that these documents will be accepted by the ethic committees without any rejection. Many thanks for the update and new information, Ingo!

In the afternoon  the group had the pleasure to listen to Oliver Herrmann, Dipl. Inf., CEO QFINITY, which reported the group in a very hands on presentation on news about CSV and GAMP (Good Automated Manufacturing Practice). First of all he explained the differences between validation, qualification and verification in detail and distinguished between process and tool. He managed the transfer from process validation and software qualification to very practical examples of everyday life. Furthermore he explained the different states a software can have: standard, slightly modified and customized and explained the different steps of risk management and needed validation, with the words: „Validate to assure that what you want is what you get“.

He pointed out that only the intended purpose should be validated and not the whole software and explained this topic with the example of Microsoft Word. If the intended purpose is to write letters, only this part should be validated and nothing more. In the course of his presentation he referred to the ICH E6 R2 and pointed out some main topics: risk based approach should be only considered if a real risk is identified, protection of the individual and the availability of the data, detection of relevance for validation and existence of SOPs. At the end of his presentation he very descriptively commented on risk based approaches with the help of daily routine procedures and the different categories of GAMP. We thank Oliver Herrmann for his very interactive and practical oriented presentation, which truly was an enrichment for the group.

After a day of full of content the GCP Clinical-Operations working group ended their session with intensive discussions on the topics of the day and planned the next two meetings in 2019, with subjects as clinical monitoring, experiences with audits and risk based approaches.

At the end of the day the chair of the group, Dr. Katja Neuer, pointed out that the GQMA Annual Meeting this year will take place in Berlin on Wednesday 27, 2019. Another interesting meeting will take place on May 07 in Bonn. Within the series of events “BfArM im Dialog” the BfArM invites to discuss the current GCP requirements in clinical trials.

The GQMA and the working groups would be happy if new members are interested to enrich the association and to assist the different working groups in their effort to help clinical development to develop better and safer therapies for all of us. Please do not hesitate to contact the group leaders directly via the GQMA Homepage if you wish to gain more insight.