Pharmaceutical Toxicology

1 week
1.5 ECTS

Aim of the course

To provide a structured overview of the role of toxicology in global drug development with a focus on Europe in one course: from early drug development to pharmacovigilance.

The learning objectives of this course is to:

  1. Get an overview of drug toxicology
  2. Understand the impact of drug quality on safety
  3. How to translate animal study results to humans
  4. Obtain knowledge on which toxicological studies are needed to:
    • conduct a First-In-Human (FIH) study
    • submit a Market Authorisation Application (MAA)
    • take into account special patient populations and specific medications
  5. Understand how to weigh a risk-benefit analysis.

The course consists of (interactive where possible) lectures and will refer for some topics to other PET-courses that are more detailed where applicable (e.g., Environmental Risk Assessment (ERA), reproduction toxicology, carcinogenicity, organ toxicology). The last part of the afternoon of each course day consists of active classes in small groups in which case studies are discussed. The course will be concluded with a presentation and a written exam. Participants should have a general knowledge of general toxicology to be able to fully profit from this course.

On successful completion of the course, participants should have knowledge on, among others:

  • ICH guidelines; including anticancer, bio-tech products, vaccines, ATMPs and FIH.
  • Procedures and timing of toxicity studies. Interactions with authorities, MAA preparation.
  • 3Rs principles, NAMs, PK/PD models.
  • Characterization and qualification impurities and raw materials.
  • Aspects of drug release and pharmacovigilance.
  • Risk (benefit), adaptive responses, relation pharmacology and toxicology, interpretation effects, mechanistic data, reversibility. Determination dose FIH, NOAEL / MABEL, ’safety margins’, ADA’s, WoE, risk mitigation, relevant species, modeling with clinical data.
  • Special patient populations: oncology, pregnancy and juveniles.
  • ERA, RMP, Labelling/SmPC.

Coordinators: Prof. dr. Daan Touw, Dr. Kris Siezen and Dr. Yolanda Ponstein

Prof. Dr. Daan Touw (Universitair Medisch Centrum Groningen, The Netherlands)
Dr. Kris Siezen (College ter Beoordeling van Geneesmiddelen, Utrecht, The Netherlands)
Dr. Tineke van den Hoorn (College ter Beoordeling van Geneesmiddelen, Utrecht, The Netherlands)
Dr. Liesbeth de Lange (LACDR / Leiden Universiteit, The Netherlands)
Dr. Ilonka van Hoof (Nonclinical Insights, Oss, The Netherlands)
Dr. Anja Slikkerveer (D2team Leiden, The Netherlands)
Dr. Danny Burg (D2team Leiden, The Netherlands)
Dr. Annelieke Peters (D2team Leiden, The Netherlands)
Dr. Lambert Creuwels (Lundbeck Eindhoven, The Netherlands)
Dr. Jasper Renz (Vico Therapeutics, Leiden, The Netherlands)
Dr. Ruth Cohen (Centrale Commissie Mensgebonden Onderzoek, Den Haag, The Netherlands)
MSc. Ankie Schoenmakers (Charles River Laboratories, ‘s-Hertogenbosch, The Netherlands)

Please note that the course can be cancelled up to one month before its starting date, when the number of applications is below the minimum required. For course-related inquiries, please contact dr. C. L. E. Siezen or dr. Y. Ponstein. For general inquiries please contact the PET Office.

Risk Assessment
Pathobiology & Toxicological Pathology