Non-clinical Safety and Toxicology

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. 

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.

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. 

Participants must

• 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 about the admission criteria.

Course coordinator
Anders Bach

Lecturers
Thomas Mow, Novo Nordisk
Helle Northeved, H. Lundbeck
Klaus Rytved, LEO pharma
Kim Kristensen, Novo Nordisk
Mette Lund Pedersen, Orphazyme
Annemette Thougaard, H. Lundbeck
Stine Bartelt, Novo Nordisk
Sophia Gry Moesgaard, Novo Nordisk
Morten Laursen, Novo Nordisk
Jørgen Schützsack, LEO Pharma
Graham Bailey, J&J
Kristin Laura Abel, Ascendis Pharma
Harrie Boonen, Lundbeck
Mikael Elander, Zealand Pharma
Louise F. S. Bang-Lauritsen, Danish Medicines Agency
Beatriz Silva Lima, Lisbon University, PT
Carsten Baun Senholt, Saxocon

The list of lecturers may be subject to change.

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 achieved a great balance between theories on guidelines and insight in practicalities.

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.

This course is offered as an compulsory course in the Master of Industrial Drug Development programme.

Priority is given to students enrolled on Master of Industrial Drug Development. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.