Courses
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Compulsory Module 1: Introduction (7.5 ECTS-Credits, 5 h)
Prerequisites for registration: none
Learning Outcome: The students understand what knowledge and skills are required for the process of drug discovery and drug development, including gender-specific aspects and requirements for drug approval. The lectures on scientific topics offer the individual opportunity to expand the required knowledge in selected sub-areas.
Compulsory Module 2: Preclinical Research and Development (15 ECTS-Credits, 9 h)
Prerequisites for registration: none
Learning Outcome: The students have knowledge of exemplary signalling pathways with relevant drug targets, understand quantitative and qualitative pharmacodynamic and pharmacokinetic aspects of the effect of therapeutic molecules and their application to preclinical drug development. They have the competence to apply theoretical knowledge for the design of preclinical studies and for the interpretation of preclinical drug data and the skill to work under conditions of Good Laboratory Practice (GLP).
Compulsory Module 3: Quality Aspects of Investigational Medicinal Products (IMP) (7.5 ECTS-Credits, 5 h)
Prerequisites for registration: none
Learning Outcome: The students have knowledge of the types of drug molecules and forms, including ATMPs and vaccines and understand the principles of design, formulation, production and quality control of medicinal products.
Compulsory Module 4: Clinical Development of Medicinal Products (7.5 ECTS-Credits, 4 h)
(no courses)
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.
Compulsory Module 5: Biostatistics and Data Management (7.5 ECTS-Credits, 4 h)
(no courses)
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.
Compulsory Module 6: Conducting Clinical Trials (7.5 ECTS-Credits, 5 h)
(no courses)
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.
Compulsory Module 7: Matters of Medicines Regulation and Market Approval (7.5 ECTS-Credits, 4 h)
(no courses)
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.
Compulsory Module 8: Application for Clinical Trial and Approval (15 ECTS-Credits, 7 h)
(no courses)
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).
Compulsory Module 9: Preparation of the Master¿s Thesis (2.5 ECTS-Credits, 0,5 h)
(no courses)
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.
Compulsory Module 10: Master¿s Thesis Defence (2.5 ECTS-Credits)
(no courses)
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.
Notes:
- There may still be changes in the courses offered as well as room allocation and course dates.
- The course descriptions found in the English version of the course catalogue are for informational purposes only. Authoritative information can be found in the "Vorlesungsverzeichnis" (German version of the course catalogue).