This e-learning course provides an understanding of the safety-related aspects within the drug development process. These range from early preclinical testing, risk/benefit assessment up to clinical adverse event signal detection and monitoring.
At the end of the course, the participants should be able to describe:
The role of drug safety in the successful development and usage of a medicine to the benefit of patients
Which safety-related questions need to be answered in early and late drug development
Tools, techniques, and methodologies used in drug safety evaluation
What frequent pitfalls related to drug safety considerations occur and why they can lead to discontinuation of drugs in development, label changes or even withdrawal of drugs from the market after launch
How changes in safety assessment could become part of a new drug development paradigm
Structure and Workload
Our e-learning courses provide an interactive environment for self-paced learning. As soon as you have booked the course, the program is accessible online for you during one year at anytime. The course allows you to start/stop at any time. There will be several intermediate tests which will prepare you for the final test. The curriculum consists of nine lessons with a duration of approximately 60 to 90 minutes each. In addition, individual study, such as critical appraisal of specific literature is required (in total: approximately 30 hours). Each lesson is aimed to achieve a set of learning outcomes, using interactive techniques to help reinforce the taught topics.
Klingelbergstrasse, Basel, Switzerland