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

Université Victor Segalen Bordeaux 2

Application deadline: 24 June 2013
Tuition fee:
  • € 7,000 / Year (EEA)
  • € 7,000 / Year (Non-EEA)
Start date: September  2014
Credits: 60 ECTS
Languages:
  • English
Location:
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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Description

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The Eu2P Master is an academic post-graduate diploma in pharmacovigilance and pharmacoepidemiology jointly delivered by Eu2P Academic Partners. This European diploma is awarded under the authority of each national Ministry of Higher Education or ad hoc authority. The Eu2P Master is both supported and recognised by Eu2P regulatory and industrial partners.

Track specializations
* The Eu2P Master offers six high level curricula to meet specific professional needs in the following specializations:
* Benefit assessment of medicines
* Medicines risk identification and quantification
* Medicines benefit-risk assessment
* Medicines and public health
* Medicines risk communication
* "A la carte" track

A job market ambition
* Each Master year curriculum is half-composed of a research project.
* Eu2P medicines agencies and industrial partners ensure * Training contents compliant with professional profiles
* Training contents and materials based on real-life situations
* Research project placements



Curriculum flexibility
* On-line based training * Attend course from wherever you are
* Make the most of your time-availability
* Easily interact with training teams and trainees' network


* On-the-job training * Learn and stay at job
* Follow each Master year in two years
* Directly apply for a Master year 2 programme

Contents

The Master year 1 programme is half-composed of theoretical training (course modules) and practical training (research project). Each part shall be successfully completed to be granted rights to pursue the second year programme of the Master in Pharmacovigilance and Pharmacoepidemiology.

THEORETICAL TRAINING

First year theoretical curriculum for the Eu2P Master in Pharmacovigilance and Pharmacoepidemiology

Module

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.

Evaluation
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.

PRACTICAL TRAINING

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.

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.

Requirements

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

Funding

Eu2P enables scholarship application for Master students.

Attributions of scholarship is based on merit and reasearch interest grounds.

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