Safety Assessment in Drug Discovery and Development

Course dates

26-30 September, 2016

Course organiser

The course is organised by the Advanced International Training Programme in Health Risk Assessment at IMM in collaboration with the Doctoral programme Environmental Factors and Health (EFH) at Karolinska Institutet, course number 2821 and the Executive and Professional Education Office at Karolinska Institutet. 

Course credits

The course corresponds to 1.5 ECTS credits. 

Learning outcomes

After the course the student should be able to: discuss the role of safety assessment during the drug discovery and development process; evaluate how animal and human data can affect the decision to pursue or discontinue a drug project; identify important parameters when going from preclinical to clinical studies; and critically discuss how predictive methods could affect the drug discovery and development process.


The course identifies the different steps of the entire process of drug discovery and development, and the critical role played by safety assessment in a drug project moving through that process. The students will discuss and practice the assessments needed during the discovery and development phases, as well as the post-marketing phase. The importance of a safety assessment during target identification is highlighted, and special emphasis is put on how to include and evaluate toxicologically relevant in silico, in vitro and in vivo methods into a drug project during the discovery phase. The regulatory requirements, covering both pre-clinical and clinical studies in the development phase, are explored, with the aim to enable the students to put animal and human data into a regulatory context. Translational safety assessment, which bridges the gap between animal and human studies, is a special focus area. New relevant methods (such as adverse outcome pathways and non-animal methods), enabling a predictive approach to the process, are introduced. The occurrence and importance of pharmaceuticals in the environment is discussed.

Teaching and learning activities

The course consists of lectures, discussions and group assignments.

Course programme

The course programme will be available here later.
The course programme for the previous course on May 4-8, 2015 is available here.

Target group

The course is intended for PhD students and other participants from academia as well as participants from authorities and industry.

Course fee

There is no course fee for PhD students. The fee for participants from academia (except PhD students) is 300 euro, from authorities 600 euro and from industry 900 euro, including VAT. Course fee includes course material, coffee breaks and a get together reception. Payment of course fee can only be accepted from the participant’s employer, not from individuals.

The participants must cover their costs for travel and accommodation.

Course application

Course application form. Deadline for application is July 29, 2016.
Accepted participants will be notified after the application deadline.
Read more about the Karolinska Institutet Privacy Policy and the Personal Data Act here.

Course leaders

Annika Hanberg, Institute of Environmental Medicine, Karolinska Institutet and Charlotte Nilsson, Swetox.


Senior lecturer

Johanna Zilliacus

Phone: +46-(0)8-524 835 44
Organizational unit: Biochemical toxicology

Health risk assessment