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Course module: DI-409-09
DI-409-09
Drug Development and Regulation
Course info
Course codeDI-409-09
EC7.5
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.
  • Motivate important decision points from the perspective of the developer.
  • Compile a development plan for a new medicinal product in line with the scientific guidelines of the registration authorities.
  • Justify deviations from the scientific guidelines for new, innovative, drugs.
  • Defend in discussion with scientific experts problems associated with the development of a new medicinal product.
  • 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.
The main topic of the first two weeks will be the pharmaceutical and preclinical development of a new medicinal product. Pharmaceutical development may include the characterization of the active substance and the pharmaceutical formulation, stability testing and storage conditions. In the preclinical development, toxicology testing, carcinogenicity and pharmacokinetics of the product, both in vitro and in vivo are at stake.  
The pivotal part of every drug development program is the clinical phase, including first in man studies in case of a new active substance (NAS), phase II and III studies, and post-approval studies (e.g. pharmacovigilance, risk management) development of new drugs and the regulatory guidelines for clinical testing will be explored. In addition, some special topics will be discussed such as pharmaco-economics, ethics, patient participation in drug development and regulatory science. In the last week of the course the project-groups have to finish and present their final project.
 
Mandatory for students in Master’s programme Drug Innovation: YES.
Optional for students in other Master’s programmes GS-LS: NO
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Kies de Nederlandse taal