The German Quality Management Association e.V. (GQMA) is the largest German specialist society for quality management in the chemical and pharmaceutical industry. The GQMA's activities include annual conferences, various working parties, advanced training courses, and the cooperation with other German and European expert associations. Together with the German Society for Pharmaceutical Medicine (DGPharMed) the GQMA publishes "PM QM" - the Journal for Pharmaceutical Medicine and Quality Management.

Our experts at CliPS - Clinical Project Services^® are members of the GQMA. Most of them have, for instance, been actively involved in the working party "GCP - Clinical Operations" for many years.

We at CliPS are delighted to inform you that on its meeting of 25 April 2019 the Board of the GQMA has decided to appoint Dr. Ingo Rath to the Extended Board. As the GQMA's representative in the "PM QM" editorial committee Ingo will help ensuring that the results of the GQMA's activities as well as current topics, discussions and insights from the field of chemical and pharmaceutical industry are being brought to the attention of a wider expert audience.

To find out more about the GQMA, please click here.

Update April 2021: The appointment to the Extended Board of the GQMA, which was initially valid for two years, was extended for a further two years in April 2021.

Update April 2023: After the end of the second term, Dr. Ingo Rath handed over his tasks within the GQMA to Dr. Bettina Quernheim and thus resigns from the Extended Board.

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The German page addresses new recommendations to German Ethics Committees assessing the qualification of investigators in clinical trials.

A publication by Dr. Christoph Ortland of Forschungsdock GmbH and Dr. Ingo Rath of CliPS in the journal PM/QM is available in German here.

If you want to learn more about current recommendations for GCP trainings for German investigators, please contact us.

We are delighted to announce that Dr. Viktoria Pavel has joined our team at CliPS - Clinical Project Services^® on 1^st January, 2019.

During her 13 years in the field of clinical research Viktoria mainly worked as project manager in clinical trials but also gained experience in clinical monitoring, medical writing, and the management of a professional investigational trial site. Working at CROs she has been in charge of studies for a wide spectrum of sponsors in various therapeutic areas and she is particularly familiar with applications to ethics committees and regulatory authorities.

Victoria already convinced us of the excellent quality of her work during a recent freelance colaboration.
We now warmly welcome her as a full member of the CliPS team and are very happy that she supports us and our clients with her substantial expertise.
 

Since it was adopted in 1996, the Guideline for Good Clinical Practice ICH E6 (R1) – better known as “ICH-GCP” – has been the internationally harmonised foundation for the planning, conduct, and reporting of clinical trials of medicinal products. Now, almost 20 years later, the content of this fundamental set of regulations has been added to for the first time.

The European Medicines Agency EMA will leave London and relocate to Amsterdam because of Brexit, which is announced for 29 March 2019. Accomplishing this change of location without massive operational restrictions is an enormous task and detailed planning has already commenced. EMA has published an interactive tool the interested public can use to track the progress of the various relocation preparations. This interactive PDF document indicates the milestones scheduled for the relocation, the progress already made, and whether there are delays to the schedule.