Pharmacoepidemiology & Drug Safety (Summerschool)

With the prospect that innovative drug therapies will be introduced in the coming years, society demands new approaches and concepts for comparative risk/benefit evaluation. These evaluations are carried out once these therapies have been used widely in daily practice. Assessment of safety and risk management of different drug therapies is done in the framework of observational epidemiological studies (proof of ‘safety’, proof of ‘effectiveness’). This is the logical next step after randomised clinical trials, which are designed to provide evidence of a drug’s ‘efficacy’. In this course students will learn about the typical problems of confounding by indication, rare side effects, risk management.

The course will cover key issues in pharmacoepidemiologic and drug safety research. Special topics include adjustment for confounding, risk detection and management, molecular pharmacoepidemiology and public health.

Our courses are aimed at clinical researchers, nurses, general practitioners, and other health professionals who want to improve their skills in epidemiology, statistics and (clinical) research.

The general objective of this course is to learn about the typical problems (e.g. confounding by indication, rare side effects) and approaches to deal with these problems in the practice of pharmacoepidemiology.

Specific goals are to gain insight in:

• study design issues in pharmacoepidemiology
• methods to adjust for confounding by indication
• methods in drug safety research
• drug safety and risk management
• overview of pharmacoepidemiological databases
• molecular pharmacoepidemiology
• drug utilization research

1 week, fulltime