PHARMACO-VIGILANCE AND PHARMACOEPIDEMIOLOGY
cod. 13400

Academic year 2008/09
3° year of course - Second semester
Professor
Academic discipline
Farmacologia (BIO/14)
Field
Ambito aggregato per crediti di sede
Type of training activity
Hub-specific activity
40 hours
of face-to-face activities
5 credits
hub:
course unit
in - - -

Learning objectives

To give to students information to apply rules on the management of safety data.

Prerequisites

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Course unit content

<br />The history of pharmacovigilance. Objectives. Definitions. Classification of adverse drug reactions. Clinical Trials: collection of safety data and establishing the adverse drug reaction profile. Causality assessment. Dictionaries and coding in pharmacovigilance. Report forms. Pharmacovigilance guidelines. The European scenario. The Italian pharmacovigilance legislation. Periodic Safety Update Report. Eudravigilance. Risk Management Plan.. An overview of vaccine safety surveillance. An overview of veterinary safety surveillance. The role of Sales Representatives. Pharmacoepidemiology (definition, objectives, models).

Full programme

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Bibliography

Notes of the Teacher

Teaching methods

At the end of the course student will be evaluated by a multiple choice test.

Assessment methods and criteria

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Other information

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