Interview: Non-Interventional Studies
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Interview: Non-Interventional Studies
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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!
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