M3 Drug Safety and Pharmacovigilance

Objectives

The European Course for Drug Safety offers training to cover the broad range of drug safety from early preclinical testing, risk/benefit assessment and clinical adverse event signal detection and survey. The course will be held during four days including small discussions on “hands-on” cases studies.

Learning Outcomes

At the end of the course, the participants should be able to describe:

• The broad range of drug safety from early preclinical testing to risk/benefit assessment
• in vivo and in vitro testing of pharmacology and toxicology and various types of trials (Special populations, ADME, dose-response, dose ranging)
• The transition from preclinical to clinical PK/PD application and design including modelling and simulation
• Regulatory issues and requirements
• Basic concepts of pharmacovigilance, data safety monitoring and adverse event signal detection and handling

Credits

The course incl. assessment provides 2 ECTS credits

Date and Venue

Details to be announced.