M.Sc. Pharmacovigilance and Pharmacoepidemiology (Master Year 1) (online study)

Eu2P: European programme in Pharmacovigilance and Pharmacoepidemiology

Application deadline: January; July
Tuition fee:
  • € 7,000 / Year (International)
Start date: September  2015
Credits (ECTS): 60 ECTS
Duration full-time: 12 months
  • English
Delivery mode: Online
Educational variant: Part-time, Full-time
Intensity: Flexible
Part-time variant: Weekday, Weekend
Structure: Semi-structured
Student interaction: Online group works/assignments
Teacher support: Continuous support with feedback on request

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Each Master trainee must conduct a research project in parallel to the theoretical training along the academic year. This research project can be achieved within an academic, regulatory or private body (see Master Programme FAQ for further details). Note: If you are employed, you can do the research project on your employer's premises. Evaluation This research project is assessed through three separates assessments: 1) the research project supervisor evaluation, 2) the project written report, and 3) the oral defence of the research project report. This practical training evaluation counts for half of the first year programme grade.



Basics in epidemiology applied to pharmacovigilance and pharmacoepidemiology

* 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

Health indices, observational studies, cohort, case-control, causality, bias, drug safety

Basics in statistics applied to pharmacovigilance and pharmacoepidemiology

* 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

Probability, descriptive statistics, statistical tests, confidence interval, regression, drug safety

Tools to do research applied to pharmacovigilance and pharmacoepidemiology

* To become familiar with the different tools that could be used in pharmacovigilance and pharmacoepidemiology research implementation
* To become familiar with the principles of scientific communication

Bibliography, redaction, presentation, funding, protocols, e-learning

Basics in clinical pharmacology

* To understand the role of medicines in therapeutics, health services and society
* To become familiar with the life cycle of medicines and the regulatory aspects of medicines market
* To review the clinical and pharmacological basis of prescribing
* To understand the need to evaluate the effects of medicines from an epidemiological perspective
* To understand the relevance of unbiased information to ensure the appropriate use of medicines
* To discuss the need to monitor medicines prescribing process

Clinical pharmacology, epidemiology, clinical trials, efficacy, effectiveness, medicines prescribing, regulation of medicines development and market

Principles of pharmacovigilance

* To enable trainees to develop an understanding of the principles of pharmacovigilance from the development of the science to its place in pre and post-marketing environment and the roles of various stakeholders within pharmacovigilance.

Introduction, regulations, legislation, principles

Basics in pharmacoepidemiology

* To understand how to evaluate the effects of medicines and therapeutic interventions both during drug development and clinical use
* To know the main methodological and ethical characteristics and limitations of randomized clinical trials
* To understand the differences between efficacy and effectiveness
* To know the basic concepts and classification of the pharmacoepidemiological studies designed to evaluate therapeutic interventions
* To identify information gaps in selected therapeutic areas (e.g. cardiovascular, psychiatry, diabetes care)

Pharmacoepidemiology, efficacy, effectiveness, benefit-risk, observational studies, experimental studies, clinical settings, population

Basics in communication applied to pharmacovigilance and pharmacoepidemiology

* 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

Communication, basic principles of risk communication on medicines

Tutored project

This tutored project aims at evaluating the ability of a trainee to work in collaboration with one or several other trainees to design and conceptualize a research project according to the Eu2P tutor instructions within a set deadline.

Each module evaluation may be evaluated through continuous and final assessment. First year trainees obtaining a pass grade in each module validate the theoretical training part of the first year Master programme.

This theoretical training evaluation counts for half of the first year programme grade.


The Master year 1 targets students and professionals with a Bachelor or an equivalence(*) in Health or Life sciences.

To be eligible, you must:

* be fluent in English (English taught training)
* be familiar with computer use and have Internet access

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