It has become increasingly certain that EU Regulation 536/2014 (Clinical Trials Regulation) will finally come into effect in 2022. This regulation will mainly harmonize the procedures for obtaining approvals for the conduct of clinical trials with medicinal products in the EU. In order to prepare physicians (investigators) working in such clinical trials for this far-reaching revision of the regulatory framework the German Medical Association and the German Ethics Committees in summer 2020 published a curriculum for an update course (available in German only). You can find a discussion of this new curriculum in an article by Dr. Christoph Ortland (Forschungsdock GmbH) und Dr. Ingo Rath (CliPS - Clinical Project Services^®) published in the scientific journal PM/QM (follow this link for the article which is available in German only). 

At CliPS we are currently preparing to add this update course to our 2021 training portfolio in order to continue to offer the full spectrum of investigator trainings for clinical trials with medicinal products in Germany. In case of any questions regarding this new update course or investigator trainings in general, please do not hesitate to contact us.