This specialisation area prepares students for work in the field of clinical research and pharmacovigilance. The ethical and legal framework for the conduct of clinical trials and for the collection and further processing of safety data will be deepened. Methods for the clinical management of development and monitoring data and their implementation in work processes provide practical insights into the world of pharmaceutical research and development. In this way, the data can be tracked from the initial collection at the trial centre to the application for marketing authorisation. Risk management and quality management form the basis here. Using practical examples, the implementation of an integrated quality management system in clinical research is explained and the management of quality-relevant documents is presented.