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.

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.

"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

WHAT YOU WILL LEARN

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.

"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

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. 

PARTICIPANTS

Participants must meet the following criteria: 
• A relevant bachelor degree or equivalent 
• A minimum of 2 years of relevant job experience 
• Be proficient in English

COURSE DETAILS

Course dates

5 days, 20-24 April 2020

Course fee

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

Application deadline

To be announced

EXAMINATION

2 hours written examination under invigilation.

Examination design: The purpose of the examination is to test whether the examinee has a broad knowledge and comprehension of non-clinical toxicology and safety pharmacology studies, overall safety assessment and relevant regulatory requirements for new drugs in development. The test is composed of multiple choice questions with one or more possible answers. 
The percentage of questions in the test, devoted to a particular topic, will roughly correspond to the emphasis given these topics during the course, and as implied in the general course objectives.Credit

2,5 ECTS

Examination date

To be announced