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.

Objectives: To enable participants (specialists) to develop an understanding of the requirements of Pharmaceutical Industry of the operational aspects of pharmacovigilance as it relates to the preparation of documents legally required by regulatory bodies. Focus will be on the adverse event reporting process within Industry, placed within the context of regulatory requirements and best practice.

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 applications of probability in statistics; To understand how to organize and describe epidemiological data; To understand how to perform data estimations, comparisons and predictions; To understand how to estimate the sample size and power of epidemiology studies; To introduce the principles of multivariable comparisons.

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

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.