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Studiegids

nl en

Regulation of Drug Safety

Vak
2020-2021

Admission requirements

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

Description

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:

  • General considerations: When is a product, like e.g. a drug, safe? Who decides that? Based on what? How do we make sure that no dangerous drugs (products) enter the market? Who is responsible for that? How do you prove that?

  • Market surveillance (Pharmacovigilance): We try to make sure that no dangerous drugs (products) enter the market, but once a large population uses it, is it still save? Who is responsible for monitoring?

  • Data mining: How do we develop safe drugs? How do you prove that? 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...

  • Challenges with natural and botanical products safety: How safe are the traditional herbal preparations? Should everything bearing a label “natural” be regarded as safe? What do we actually know about the “naturals”, being made as biotechnological compounds?

  • Environmental impact of drugs: 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?

  • Safety of cosmetics and supplements: How are “non-pharma” health-related products regulated? Similarities and differences with drugs regulations and safety assessment approach.

  • Quality and safety “management” of drugs at manufacturing: How do we ensure safety and quality at manufacturing level? Who is responsible for that?

  • Conclusions: How do all these safety requirements impact the availability of drugs and innovation?

Course objectives

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

  • General regulatory principles for pharmaceuticals, herbal medicines, medical devices, cosmetic products, food supplements.

  • In depth requirements with regard to regulation of safety of human pharmaceuticals

  • General 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.

Timetable

The duration of the lecture series is 6 days spread over 3 weeks (March/April 2021). Each day includes a lecture/presentation in the morning and presentation or activity in the afternoon (literature research and discussion, a guest speaker or a visit, discussion or a debate on actual cases and examples). Attention of all days is obligatory, as the exam will be based on presentations and discussions.

Examination: April 2021

The specific schedule for this course will be published on Brightspace.

Mode of instruction

Lectures, literature research, case studies and discussions.

Assessment method

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

Reading list

The reading list will be given on the Brigthspace per topic just a few weeks before the start of the course. These are given as presentations and pdf files. There is no need to purchase literature, as the presented material is not commercialized.

Registration

Application via uSis. Registration closes 14 days before the start of the course. After this date only with approval of course coordinator.

Contact

Coordinators:
Dr. J.W. van der Laan, Division of Toxicology, LACDR, and Medicines Evaluation Board, Utrecht.
E-mailaddress: jw.vd.laan@cbg-meb.nl

Drs. Z. Gavrić, The Regulatory Company, The Hague
E-mailadress: z.gavric@theregulatorycompany.com)

Remarks

There is a limit of max. 24 students for this course. Placement is based on the registration date.

This information is without prejudice. Alterations can be made for next year