Online-Seminar

Adapted to the ongoing pandemic, the symposium will be held online via zoom. It is dedicated to current topics in clinical research, including big data, ePRO and risk-based monitoring.

MEGRA, start-up medical devices and MDR. Online course with 8 modules from 1:00 p.m. to 5:30 p.m. Dr. Andrea Röthler gives a lecture on the subject of clinical requirements.

One live webcast per month with proven experts from medical affairs with the possibility of discussion via audio and chat. Rupert Lang, GKM Gesellschaft für Therapieforschung mbH, Chief Operations Officer, gives a lecture on application monitoring (study synopsis, notification, ethical vote, etc.)

Medical devices have to be safe and efficient. Appropriate clinical data are required to substantiate this. Dr. Andrea Röthler gives a lecture in an online event on the subject of clinical trials with medical devices: PMCF studies, planned date April / May 2022

In German language: Seit dem 31.01.2022 ist die Clinical Trial Regulation 536/2014 (CTR) in der Praxis anwendbar. Es gibt eine Übergangsfrist von drei Jahren, in der sowohl die EU Richtlinie 2001/20 als auch die EU Verordnung 536/2014 parallel laufen.