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Non-clinical Safety and Toxicology
Non-clinical safety assessment of a potential pharmaceutical is an essential part of modern drug development. Learn about the regulatory requirements for non-clinical safety studies in vivo and in vitro.
This course is a part of
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.
Course content
The course concerns investigations used in the non-clinical safety assessment of new drugs. These include evaluation of general toxicity and safety pharmacology, genotoxicity, carcinogenicity, and reproductive toxicity but also aspects of ADME (absorption, distribution, metabolism, excretion) and toxicokinetics in relevant species.
The objective of the course is to introduce participants to non-clinical safety assessment and to give participants an insight in the requirements and the conclusions to be drawn from the results of non-clinical safety studies conducted in vivo as well as in vitro.
The course was highly relevant because of the guest speakers from the industry and the real-life cases that were presented to us.
The course has increased my awareness of what authorities need in order to evaluate new drug applications and taught me how to use the guidelines more efficiently.
Course director and lecturers on Non-clinical Safety and Toxicology
Course details for Non-clinical Safety and Toxicology
Dates and examination
Course dates
Spring 2026
The course is available every second year.
Examination
Please find the exam dates in the exam plan.
You can find further information about the course and the exam in the course curriculum.
See an overview of all courses on Master of Industrial Drug Development.
Learning outcomes
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.
Admission criteria
Professionals in need of interdisciplinary overview
The course is for professionals in the pharmaceutical industry who needs a basic understanding of non-clinical safety assessment. You will gain insight in the requirements and the conclusions to be drawn from the results of non-clinical safety studies conducted in vivo as well as in vitro.
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent
- Have a minimum 2 years of relevant job experience in drug development
- Be proficient in English
Find detailed information in the admission criteria on Master of Industrial Drug Development.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Industrial Drug Development programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Tuition fees
EU/EEA citizens: 12,050 DKK
Non-EU/EEA citizens: 13,825 DKK
The fee includes lunch/coffee.
Place
University of Copenhagen
Department of Pharmacy/
Department of Drug Design and Pharmacology
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66