LFU:online

Prerequisites for registration: successful completion of the compulsory modules 1 and 2

Learning Outcome: The students have knowledge of the process of clinical drug development and of the criteria required. They have an in-depth understanding of the regulatory environment for medicinal products in Europe and understand the principles of GMP with a focus on drug development. They are able to understand the framework for the clinical introduction of medicinal products.

Prerequisites for registration: none

Learning Outcome: Students acquire knowledge of the principles of biostatistics as well as the competence to apply them in the context of the drug development process, in particular for statistical planning of clinical trials.

Prerequisites for registration: successful completion of the compulsory modules 1 and 2

Learning Outcome: Students will gain knowledge of the main principles of clinical trial design and how trial design can influence the approval process, including drug safety assessment and documentation. They will gain in-depth knowledge of the necessary documents and processes required to initiate and conduct clinical trials, including regulatory filing and the principles of Good Clinical Practice (GCP), and will be able to apply this knowledge independently.

Prerequisites for registration: successful completion of the compulsory modules 1 and 2

Learning Outcome: The students acquire knowledge about the procedure for applying for market authorization and understand post-market drug safety surveillance, including pharmacovigilance and risk-benefit assessment. They know how to find official scientific advice and how to create a ¿briefing book¿. The students understand the principle of market analysis for the medical demand for drugs. They have the necessary skills to independently implement knowledge about the protection of intellectual property, the bioequivalence of medicinal products and data protection in the process of market access.

Prerequisites for registration: successful completion of the compulsory modules 1 to 7

Learning Outcome: Students have the practical skill to file an application for a clinical trial of a medicinal product including the study design. They have the competence to provide regulatory scientific advice for a hypothetical medicinal product application and to create the required documentation for a medicinal product (investigational or for approval) in CTD format. The students acquire the knowledge how to manage data within the application process and have an in-depth understanding of the calculation of quantitative parameters (e.g. cost-benefit parameters).

Prerequisites for registration: successful completion of elective module 1 or 2

Learning Outcome: After successfully completing the module, the students are able to write a brief description of the content of the planned Master's Thesis (synopsis), to outline the timeline of their project and to draw up a written Master's Thesis agreement.

Prerequisites for registration: successful completion of all other compulsory and the required elective modules as well as the Master¿s Thesis

Learning Outcome: The students are able to reflect on the overall context of the Master's Thesis as part of the master's programme. In doing so, they demonstrate theoretical understanding, methodical foundations and have the ability to impart the results of the Master's Thesis and to present them accordingly.