Theoretical training in toxicology, with associated practical working to re‐enforce concepts, is essential. Such training can be provided on a modular basis. It should provide basic knowledge of the major areas of toxicology and embrace at least the topics defined below.
A candidate for registration will have undertaken theoretical training in the following core topics areas B1 - B13 and in at least two elective topic such as listed under B14 – B22:
B 0. Introduction: History, Tasks, Scope and Ethical Principles of Toxicology
B 1. Animal Science incl. Ethical Rules and 3 R Principle
B 2. Experiment Design, Biometry and Statistics
B 3. Cellular Toxicology and Molecular Toxicology
B 4. Metabolism and Kinetics of Xenobiotics
B 5. Organ Toxicology and Toxicological Pathology
B 6. General Toxicology, Introduction to Risk Assessment
B 7. Environmental Toxicology, Exposure Assessment and Biomonitoring
B 8. Epidemiology, Toxicogenetics
B 9. Clinical, Occupational and Forensic Toxicology
B10. Mutagenesis and Carcinogenesis
B11. Reproductive and Developmental Toxicology
B13. Regulatory Toxicology
In addition, two topics, listed below are mandatory:
B14. Drug Safety Assessment: Non‐clinical, Clinical, Post‐Approval Studies, Safety Pharmacology, Expert Report, Drug Regulation
B15. Safety Assessment of Food, Cosmetics and Other Consumer Products, Regulations
B17. Risk Assessment
B18. Neurotoxicology and Behavioural Toxicology
B20. Alternative Testing Methods and their Use in the Regulatory Framework
B21. Computational Toxicology
B22. Mechanistic Toxicology and “Omics” in Toxicology
Topics B0 – B13 and some of the elective topics are essentially covered in the existing ERT courses in Europe.
Topics may be presented as modules consisting of lectures, site visits, demonstrations, and exercises. Case studies by individual participants are particularly encouraged to practise risk assessment and classification of chemicals. Distant teaching and learning will be used where feasible. At completion of each topic an examination has to be passed.
Course level, and time needed
Course levels will correspond at least to the Master level. Each topic will probably involve 3‐5 days, in some cases up to 10 days of contact time, except B0, which may require only a few hours. If studied from the beginning, with no credit given for content of previous degrees, then about 15‐26 weeks of 30 hr per week contact time should be allocated to undertake the theoretical basis needed for eventual registration.
Comprehensive topics: Some elective topics such as B14, B15, B16, B17, may be organized to offer comprehensive specialized training. They will usually consist of more than one module and will need more than 10 days of contact time.
Candidates for registration will be expected to present credits in all 13 core and the 2 elected topics. This syllabus can be certificated partly or entirely if the respective content has been covered in an appropriate previous degree (MSc, Ph.D.) or course. Credits may be obtained from modules based in more than one country.