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. By working on case studies, the participants will acquire a strong understanding of the role(s) of toxicologists in the field of regulatory toxicology.

Content and structure of the course
The first day (Monday) of this course consist of E-lectures that provide the participants with general knowledge on Legal and Regulatory Toxicology. On-site, the course will go in more depth into the different legal and regulatory frameworks that exist 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. Overarching aspects such as animal testing and good laboratory and good clinical practices will also be discussed.

Recommended preparation of the course
It is recommended that participants have followed the course on Risk Assessment, or have work experience in risk assessment, before entering Legal and Regulatory Toxicology. Presentations of the lecturers will be placed on the online learning environment. 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

Location
The on-site classes of the course will take place at the National Institute for Public Health and the Environment (RIVM) in Bilthoven. Participants will need to bring official identification (eg. passport) to enter the RIVM.

Lecturers
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

Examination
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: 5 days
ECTS credits: 1,5
Fee:          see tuition fees (includes reduced fees for PhD students)
Location: distant learning from home location and on-site classes at the RIVM, Bilthoven (see also above at ‘location’)
For general inquiries please contact the PET Office

To apply please proceed to course registration and for questions please contact the PET Office

Last updated: 13-Feb-20