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Regulation of Drug Safety



Are you sure that the little pill you take each morning is really safe?

The goal of this lecture series is to provide a thorough understanding of several socially very relevant aspects of drug development. This subject is an essential link between science, industry, government and patients.

Subjects to be handled:

  • “Safe? Says who?!?” When is a product, like e.g. a drug, safe? Who decides that? Based on what?

  • “Don’t worry, it’s safe! I’ve tested it on guppies…(or guinea pigs).” How do we make sure that no dangerous drugs (products) enter the market? Who is responsible for that? How do you prove that?

  • “I need to test it on what???” Data mining: How much more do we need to know? What can we do with all the existing data? Structure-activity relationship, metabolism and exposure models, etc… Tools: What extra tools do we need more? Animal testing, alternative models, etc…

  • “Off course it’s safe, it’s NATURAL!” Synthetic drugs vs. botanical preparations vs. endogenous biotech molecules: How safe are the traditional herbal preparations? How safe are the biotech-produced endogenous molecules? Should everything bearing a label “natural” be regarded as safe? What do we actually know about the “naturals”?

  • “Well, we’ve proven it is safe for human use, are we done now…?” What about the non-functioning water treatment plants due to high levels of antibiotics in sewage water? What about the impaired fertility of aquatic organisms due to high levels of anti-conception (pill) residues in local waters?

  • “If everything is just a bunch of chemicals, why do we need all these different rules?”
    i Precautionary principle vs. Risk-based assessment;
    ii Pharmaceuticals vs. food vs. industrial chemicals vs. cosmetics;
    iii Differences in approach and mentality (US vs. EU).


Dr. J.W. van der Laan, Drs. Z. Gavrić

Admission requirements

Master’s Students of Bio-Pharmaceutical Sciences, Biomedical Sciences, Life Science & Technology, Molecular Science & Technology.

Mode of instruction

Lectures, literature research, case studies and discussions.

Course objectives

At the end of the course the students have knowledge about:

Regulatory principles for pharmaceuticals, herbal medicines, cosmetics in comparison with industrial chemicals.- In depth requirements with regard to safety of human pharmaceuticals

  • Aspects of Environmental Risk Assessment of pharmaceuticals

  • Differences between safety testing of small molecules, biotechnology-derived proteins and vaccines.

    Students are expected to have a thorough understanding of regulatory aspects of drug development in comparison with other regulatory areas as well. This subject is an essential link between science, industry, government and patients. ### Assessment method

Oral group presentations during the course and written examination (open as well as multiple choice questions), depending on the number of participants.


The duration of the lecture series is 6 days spread over 4 weeks. Each day includes a lecture/presentation part in the morning and an activity in the afternoon (literature research and discussion, a guest speaker or a visit, discussion or a debate on actual cases and examples)
Examination: October/November 2015


Application via uSis. Registration closes 1 month before the start of the course. After this date only with approval of course leaders.