The essay is an essential part of the CAS program „Pharmaceuticals – From Research to Market“ (CAS Pharm) and serves as final performance assessment.

Students learn about the different health systems, primarily about the European and the Swiss specialities, then also in comparison with the US system. A short introduction is made about Marketing with focus on Pharma, the legislation and patents/licencing are discussed and pharmacooeconomic aspects and business development are explained and intensified through workshops.

In this module, students learn to plan, execute, and manage pharma industry projects effectively, emphasizing clear objectives and timelines. They develop skills in team collaboration, conflict resolution, and stakeholder communication to ensure project success. Students also enhance their ability to convey ideas clearly and persuasively to diverse audiences through role-playing exercises.

Students learn about pharmaceutical regulations in Switzerland, EU and US, various quality systems and CAPA, quality risk management, life cycle management, quality assurance of biotechnological processis, process validation, quality by design, statistical tools in QA, computerized systems validation, quality aspects of packaging and the role of the qualified person.

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Students learn about the pharmaceutical drug development process from the analytical characterisation of drug product both for small molecules and biotechnological drug substandes. The learnings include: formulation of clinical and market form, scale-up, 2D/3D printing technology for drugs, clinical trial supply, commercial packaging, supply chain management and continuous manufacturing.

Students learn about the regulatory aspects of drug development, about the Swiss, European and FDA regulations, regulatory information and strategies, personalizing healthcare and the role of companion diagnostics, about special regulations for biosimilars, medical devices, generics, orphan drugs, GMOs and advanced therapeutics incl. gene therapy and pharmacovigilance.

This module gives an overview about the several steps that have to be followed during the process of clinical development.

Knowledge of the fundamentals of development, preparation, testing and stability of sterile radiopharmaceutical preparations.Acquirement of basic information on European legislation in Radiopharmacy including GMP and Pharmacopoeia.Understanding basics of gene engineering and pharmacokinetics

Knowledge about the fundamentals of radionuclide production and generator systems, design and in vitro-& in vivo-characterization of radiolabelled peptides and antibodies., chemistry of Tc, Re and other radiometals, including the usage of kits as well as of chemistry of 11C and 18F and of other radiohalogens.

Knowledge about the fundamentals of pharmacokinetics and pharmacokinetic modelling, the basic concepts of pharmacology and toxicology, radiopharmaceutical monographs in the European pharmacopoeia, radiological imaging modalities and the basics of applied statistics in biomedical research. Understanding the fundamentals of nuclear medicine: Diagnostic applications in neurology and oncology therapy.