8 April 2024

Non-clinical Safety and Toxicology

Non-clinical safety assessment is an essential part of modern drug development. Learn about the regulatory requirements for non-clinical safety studies in vivo and in vitro

Non-clinical Safety and Toxicology

Non-clinical safety assessment of a potential pharmaceutical represents an essential part of the drug development process. The high attrition rate seen late in development programmes has caused an intensification and expansion of the field of safety science, towards a much more integrated view of safety from early discovery to post-marketing safety monitoring.

Exercises are based on case stories where you will be presented with real toxicological data in a stepwise manner and asked to formulate qualified conclusions at each step. This enables you to solve issues that you would encounter in your daily work life and integrate various safety aspects in the overall assessment for selection of drug candidates. The course setup will allow you to develop your knowledge in close collaboration with fellow students and leading scientists from the university, pharmaceutical industry, and health authorities.





















Upon completion of the course, you will be able to:

  • Provide information on regulatory requirements for studies used in non-clinical safety assessment
  • Describe the major organ systems to be examined in non-clinical safety assessment
  • Outline special conditions for assessment of toxicological aspects of biopharmaceuticals.
  • Understand non-clinical safety assessment in vivo as well as in vitro
  • Identify and argument for relevant animal species and organs used in safety studies
  • Design in vitro genotoxicity tests
  • Integrate various safety aspects in the overall risk assessment for selection of drug candidates.





































































Course details

Duration: 5 days on campus
Dates: 8-12 April 2024
Frequency Only available every second year
Place: University of Copenhagen, Copenhagen, Denmark
Course fee: EU/EEA citizens: 10,750 DKK
Non-EU/EEA citizens: 12,488 DKK

Fees may be subject to change in 2024

The fee includes lunch/coffee.

Payment conditions

Level and credit: Master course; 2,5 ECTS
Examination date: Please consult the exam schedule
Application deadline: 8 weeks prior to course start
Admission: To be admitted, you must meet the admission criteria for Master of Industrial Drug Development

Course dates and application deadlines are announced via the  programme newsletter.
Download course curriculum