Welcome to the GCP Mindset Channel, on this channel we inform you about the latest trends and topics in clinical research. The channel contains a mixture of presentations and interviews about several topics which are interesting for persons who work in the clinical research enviroment. The channel has been established by Dr. Andreas Grund, who works since 1997 in the clinical research world at the university and for CROs in different positions. We are happy to share our expertise for a fruitful discourse with you. Do you have a topic in mind that should be adressed in one of our podcasts? If yes, do not hesitate to contact us! The GCP Mindset Channel is powered by GCP-Service International, a 100% privately owned full-service CRO, which conducts clinical studies in several indications globally.
https://ukf9s6.podcaster.de/
Interview: Non-Interventional Studies
Our new podcast is about non-interventional studies in the regulatory point of view. We invited Andreas Coors, an expert in regulatory affairs, to discuss the topic. He has a background in biology and neurobiology and has worked as a regulatory affairs manager for several years. Non-interventional studies are quite complicated from a regulatory point of view due to the patchwork of local applicable laws within the EU and the lack of clear regulations. The regulations for non-interventional studies are lacking for both pharmaceutical and medical device studies. Non-interventional studies are done for different purposes, some are required by competent authorities for gathering additional data, such as safety data, while others are done by the sponsor for collecting additional data. Learn more in our new podcast!