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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


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

Methods of Instruction

Lectures, literature research, case studies and discussions.


Oral presentation and written examination, depending on the number of participants.

Time Table

The duration of the lecture series is 6 days spread over 4 weeks, see roster Lecture Series [menu on the right, under ‘files’ or ‘bestanden’]. 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: November 5th 2014


Application via uSis.