Drug Development and Regulation

FaculteitFaculty of Science

NiveauMaster

Studiejaar2026-2027

Beschrijving

Course goals

After completing the module the student is able to:

Describe the general principles of medicines regulation (both pre-and post-approval) at EU level.
Distinguish and describe the phases of drug development.
Understand the role of different stakeholders involved in drug development.
Apply regulatory requirements to the drug development process of a new medicinal product.
Critically appraise registration dossiers of authorized medicinal products.
Justify choices in drug development in a discussion with regulatory experts.
Experience the value of working in multidisciplinary teams.

Content

In this course, you will learn about the processes of drug development and drug regulation, with a special focus on drug licensing (also named registration). The drug regulatory system also encompasses regulations on clinical trials, inspections of Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) or Good Pharmacovigilance Practice (GVP). You will learn about the many steps that have to be made by drug developers, mostly the pharmaceutical industry, after drug discovery (DI-408). The course is organized by the Department of Pharmaceutical Sciences of the Utrecht University, in collaboration with the Medicines Evaluation Board of the Netherlands (CBG-MEB) and other experts from the drug development field.

You will study the process of drug development with the aim to bring a medicinal product in a licensed fashion to the market. While in the past most medicines on the market were small chemical molecules, nowadays the pharmaceutical industry is increasingly focusing on the development of biologics (peptides, proteins, antibodies) and so called advanced therapeutic medicinal products (ATMPs, including gene, cell and tissue based therapies). In the course we will offer a wide range of case studies covering these different therapeutic scenarios from drug repurposing to novel high-tech therapies. The cases studies are selected to stimulate your scientific, innovative and creative thinking, and to challenge regulatory principles and guidelines if appropriate.

This course addresses the five domains in regulatory science training for academia as defined by the STARS consortium: 1) the EU regulatory system, 2) quality, 3) non-clinical, 4) clinical, 5) post-marketing surveillance.

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