Non-clinical Safety and Toxicology – University of Copenhagen

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Master of Industrial Drug Development > Courses > Non-clinical Safety an...

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.

"

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.

Lene Jessen, Director of Department of Pharmacology, Zealand Pharma

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. 

What do you gain?

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.

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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

Vibeke Stennicke,Senior non-Clinical

safety Project Manager, Novo Nordisk

Closely related to your professional life

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 dates: 16-20 April 2018

Exam date: 23 April 2018 (may be subject to change)

Application deadline: 19 February 2018

Course fee:

  • DKK 10,750 for EU/EEA citizens
  • DKK 12,488 for non-EU/EEA citizens