Course Syllabus

A Introduction

Pharmacovigilance
General aims
Specific aims
Pharmacovigilance centre (PvC)

B Which approach to pharmacovigilance?

Spontaneous reporting
Targeted spontaneous reporting (TSR)
Active surveillance

C Spontaneous reporting

Introduction
Objectives and methodology
Minimum reporting requirements
How to report
What to report
When to report
Who should report
Follow-up
Sharing the results
Data entry

D Targeted spontaneous reporting (TSR)

Introduction
Objectives and methodology
A PRACTICAL HANDBOOK ON THE PHARMACOVIGILANCE OF MEDICINES USED IN THE TREATMENT OF TUBERCULOSIS
E Cohort event monitoring (CEM)
Introduction
Objectives and methodology
Implementation
Establishing the cohort(s)
Acquiring the data
Database for CEM
Maximizing the reporting rate
Practical advice and information
Clinical review

F Data processing

G Relationship and causality assessment

Background
Relationship (“objective phase”)
Categories of relationship
Processes for establishing the relationship
Causality (“subjective phase”)

H Special types of event

Serious events
Pregnancy
Lactation exposure
Deaths
Lack of efficacy
Late onset reactions
Co-morbid conditions

I Signal identification

Introduction
Selection criteria for events to investigate
Methods of signal identification

J Evaluating a signal

General approach
Other experience
Searching for non-random patterns
Comparison with control events
Pharmacology
Undertaking epidemiological studies
Communication and feedback

K Identifying risk factors

Introduction
Identification

L Data description and analysis

M Organization

Legislation
Ethical issues
Structure
Communication

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