Yesterday, our colleagues of ICRC-Weyer participated in the BB Life Seminar dealing with the new EU regulation 536/2014 on clinical trials on medicinal products for human use.
The EU regulation is valid since 2014. However, it will be applied earliest this year. The seminar informed about the new legal situation in conducting clinical trials and presented a general view on step changes in contrast to the previous guideline 2001/20/EG as well as its utilization.
Additionally, the participants were informed about the current legal situation of medicinal products in Germany and the manufacturing of investigational products in clinical trials.