Aim of the course
The aim of the course is to introduce participants to the field of legal and regulatory toxicology. Regulatory toxicology is the process of producing, collecting and evaluating of experimental toxicology data to facilitate toxicologically based decisions directed towards the protection of humans and the environment against harmful effects of chemical substances. Regulatory toxicology supports the development of standard protocols and harmonized testing methods in order to improve the scientific basis for the risk management processes. The course consists of lectures on the various aspects of regulatory toxicology by selected experts.
Content of the course
The course will deal with the different legal and regulatory frameworks that are operational in the risk management of chemical substances such as additives, plant protection products, consumer products, veterinary and human pharmaceuticals and industrial chemicals, and other dangerous products. Requirements with respect to animal testing, and good laboratory and good clinal practice will be discussed, as well as enforcement and inspection issues.
Recommended preparation of the course
It is recommended that students are familiar with the process of risk assessment, eg. have followed the PET- course on risk assessment.
Presentations of the lecturers will be placed on Blackboard. It is recommended that students bring their laptops to the course in order to view the presentations. Wi-Fi is available in the lecture room. For sustainable use of paper, printed handouts will only be available on request.
Outcomes (competences, skills)
On successful completion of the course the participant should:
- have obtained knowledge on the general approach of regulatory toxicology of chemical substances;
- have learned how to apply the science behind the risk-based decision making;
- have obtained knowledge on the practical aspects of the interpretation and presentation of experimental results in the framework of standard setting, notification and registration of substances;
- have obtained insight in the role of different (inter)national authorities in the field of regulatory toxicology;
- have obtained insight in the role of toxicologists in the field of regulatory toxicology, either working for a national or international regulatory authority, for industry or for other stakeholders
The course will take place at the National Institute for Public Health and the Environment (RIVM) in Bilthoven. Students will need to bring official identification (eg. passport) to enter the RIVM.
Ir. Astrid Bulder, RIVM, Bilthoven
Dr. Joke Herremans, RIVM, Bilthoven
Dr. Martien Spanjer, NVWA, Utrecht
Dr. Pieter Brekelmans, UMC Utrecht, Utrecht
Dr. Martijn Beekman, RIVM, Bilthoven
Dr. Josje Arts, AkzoNobel, Arnhem
Prof.dr. Bas Blaauboer, IRAS, Utrecht University
Dr. Anne Kienhuis, RIVM, Bilthoven
Dr. Susan Wijnhoven, RIVM, Bilthoven
Dr. Saskia Bosman, Ctgb, Ede
Dr. Ira Koval, Charles River, Den Bosch
Dr. Coen Graven, RIVM, Bilthoven
Dr. Jan Willem van der Laan, Medicines Evaluation Board, Utrecht
Dr. Peter Keizers, RIVM, Bilthoven
Dr. Wim Best, Health Care Inspectorate, The Hague
The participants are expected to actively particpate in the discussions during the course and have to take a written exam on the lessons learned at the end of the course.
Course coordinator: Ms.ir. Astrid Bulder
Duration: three days
ECTS credits: 1
Fee: see tuition fees (includes reduced fees for PhD students)
Location: National Institute for Public Health and the Environment (RIVM), Bilthoven
For general inquiries please contact the PET Office