Objectives: To learn about available methodologies for quantitative benefit/risk assessment, to gain insight in the strengths and weaknesses of these methodologies, and to apply these methodologies in practice. Decision making on medicines informed by quantitative benefit-risk assessment may differ depending on the perspective of the decision maker and the phase of drug development.

Objectives; To know the basic principles of communication and to gain an insight into the characteristics of effective communication. To face to the complexity communication on risk for health. To know the evolution of medicine risk communication.

Objectives: To understand effect modification. To understand the principles of genetic susceptibility for drug risks

Objectives: To analyse and discuss strengths and limitations of randomised clinical trials and other epidemiological studies. To analyse and discuss strengths and limitations of evidence-based medicine. To undertake complete critical appraisals of different randomised clinical trials and meta-analysis of randomised clinical trials.

Objectives: To analyse and discuss the role and the impact of medicines in therapeutics, health services and society. To understand the pharmacological and clinical essential principles of prescribing. To understand the pharmacological, clinical and epidemiological principles underlying the effects (both beneficial and unwanted) of medicines in various populations.

Objectives: To understand the need to design and to carry out qualitative drug utilisation research. To be able to critically appraise qualitative drug utilisation studies (DUS). To design, to implement and to discuss small-scale audits on the quality of medicines use in hospitals and in primary health care.

Objectives: To gain insight in the process of decision-making on medicines by different stakeholders. Decision making on medicines informed by quantitative benefit-risk assessment and pharmacoeconomics may differ depending on the perspective of the decision maker and the phase of drug development. This module addresses the decision-making on medicines by different stakeholders.

This module will address in more depth the challenges (rationale , emotional and logistical) of Risk communication that have been raised in previous modules.

Objectives: To gain insight into different preference valuation techniques and (pharmaco)economic evaluation methods. This module will address valuation of health states and pharmacoeconomic evaluation methods. Economic consideration play an important role in decision-making on medicines, e.g. for reimbursement purposes.

Objectives: To understand the basic concepts and principles in epidemiology; To become familiar with the epidemiological tools that could be used in pharmacovigilance and pharmacoepidemiology; To understand the specificity of epidemiological tools applied to pharmacovigilance and pharmacoepidemiology.