Aim of the course
This postgraduate course introduces the field of reproductive toxicology from the viewpoint of a variety of contributing disciplines. Starting from basic toxicological and embryological concepts it covers subjects from experimental research to clinical studies and epidemiology. Specific topics include advice on drugs use in pregnancy, the teratology of antiepileptic drugs, folic acid deficiency and neural tube defects, and the classical and still topical DES saga. Special attention is given to the interpretation of animal reproductive toxicity studies which form the basis for human risk assessment of chemicals. Students will receive timely subjects for self-study in subgroups culminating in presentations on Friday.
Content of the course
– General Introduction.
– The reproductive cycle: definitions, history, disciplines, human and animal studies.
– Fundamental and applied research, risk evaluation and risk management.
– Alternatives to animal experimentation.
– The DES Saga: Pathology and epidemiology of DES effects, mothers and sons/daughters.
– Clinical Teratology: genetic predisposition versus exogenous exposures, clinical research and counselling.
– Drugs use in Pregnancy: safety evaluation, exposures in pregnancy, post-marketing surveillance of drugs, risk communication.
– Epidemiology of congenital malformations: study types with pros and cons, birth defects registries, examples of congenital anomalies.
– Folic acid and neural tube defects, nutrition and pregnancy, folic acid requirements, epidemiology.
– Risk assessment in Reproductive Toxicology: overview of guideline-based animal study test protocols, their use in testing strategies, parental versus fetal toxicity.
– Risk assessment in Reproductive Toxicology: Workshop with practical examples of animal study results
– Presentation of self study reports
Outcomes (competences, skills)
• knowledge of the general principles of reproductive toxicology
• knowledge of selected human teratogens and their epidemiology and clinical teratology
• knowledge of modes and mechanisms of action of selected reproductive toxicants
• knowledge of innovative approaches towards mechanisms of reproductive toxicity
• knowledge of regulatory hazard assessment methodologies in reproductive toxicology
• knowledge of alternative methods to animal testing in reproductive toxicology
• knowledge of internationally harmonized testing strategies in reproductive toxicology
Prof.dr. A.H. Piersma, RIVM, Bilthoven (course leader)
Dr. G.P. Bailey, Janssen Pharmaceutica, Beerse, Belgium.
Mrs. Prof.dr. M.C. Cornel, VU Amsterdam
Drs. M.E.T.A. Koster, DES-Center Utrecht
Mrs. Prof. Dr. L.T.W. de Jong-van den Berg, Groningen University
Prof.dr. D. Lindhout, UMC Utrecht
Mrs. Dr. R.P.M. Steegers-Theunissen, St Radboud MC, Nijmegen.
Course coordinator: Prof.dr. A.H. Piersma
Duration: 1 week
ECTS credits: 1.5
Number of participants: 10-20
Period: for exact dates, please consult the current programme schedule
Fee: see tuition fees (includes reduced fees for PhD students)
Location: Institute for Risk Assessment Science, Utrecht University