“For healthcare products that require clinical studies to support licensing or regulatory clearance the execution of the clinical plan is the most critical stage in the product development process of a company. For young companies the success of a clinical study is very crucial and determines if the company is able to continue its product development program and eventually get market approval by the regulatory organisations such as the FDA and EMA.
In this expert class the design of the clinical studies will be discussed from the perspective of three different healthcare products including an Immunotherapeutic compound, a heart rate home monitoring mobile app and a diagnostic biomarker for respiratory tract infections. What are the requirements of the different clinical studies, the timelines, required partners and costs. Is it possible to speed up clinical studies by applying other strategies?
The expert class program is set up in an interactive way such that the participants have the possibility to bring their own questions and discuss issues they encounter in their own (start-up) company and/or business case. The expert class will also give the possibility to broaden the participants network.”