After completing the module the student is able to:
- distinguish and describe the phases of drug development.
- explain the role of regulatory affairs in drug development.
- understand important decision points during the development of new drugs.
- understand the role of different disciplines involved.
- work in an international, multidisciplinary team.
- systematically solve problems and perform literature research on drug development and regulatory affairs.
- write a development plan for a new drug based on the scientific guidelines of the registration authorities.
- scientifically justify deviations from the scientific guidelines for new, innovative, drugs.discuss the problems associated with the development of new, innovative, drugs.
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Description of content
In this course you will study the process of drug development and drug regulation, both processes that are an essential part of the drug pipeline. There will be an emphasis on new innovative drugs and therapies like novel vaccins, miRNA, antibodies, and gene- and stem cell therapy.
In the first week of the of the course the pharmaceutical development of a new drug is the main topic. Furthermore, the quality assessment of these processes is an important aspect.
The second main topic of the course is the preclinical safety assessment of new drugs. Attention will be paid to the extrapolation of in vitro and in vivo data from preclinical tests to man (translational medicine).
Next, the clinical development of new drugs and the regulatory guidelines for clinical testing are discussed. Finally, attention will also be paid to post-marketing surveillance (pharmacovigilance). In addition, some special topics will be discussed such pharmacoeconomics and pharmamanagment. In the last week of the course the project-groups have to finish and present their final products.
Lectures, workshops and background literature are offered to obtain a firm understanding of drug development and to provide examples from the viewpoint of the industry, academia research, regulatory authorities and patients. Furthermore, you will spend half of your time in teams to make a development plan for a new, innovative drug.
Literature/study material used:
Drug Discovery and Development: Technology in Transition. Edited by H.P. Rang. Churchill Livingstone 2006. ISBN 978-0-443-06420-3
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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