How to write an individual case narrative, assess causality and expectedness of cases, and determine certainty of diagnosis according to Brighton collaboration guidelines.

Module's directors

Bernadette Hendrickx, MD

CEO and CEO & Founder, Science Applied for Human Biology Consulting (SAHBC), Master Senior Medical Advisor
Genval and Siena

Corinne Jouquelet-Royer, MD

VP, Head of Pharmacovigilance Vaccines
Sanofi Pasteur, France

Emanuele Montomoli, BSc, MSc, Full Prof.

President of the Master TSC, Full Prof. of Public Health
Dept. of Molecular and Developmental Medicine, University of Siena, Italy


See the lessons' list

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Lessons' List

Introduction to Pharmacovigilance and Risk Management
Discussion and Q&A session
Principles of Pharmacovigilance
How vaccines differ from drugs?
Specificities of Vaccines Safety
Workshop: Principles of pharmacovigilance, how vaccines differ from drugs, specificities of vaccines safety
Classification of adverse events
Pharmacovigilance in developing countries
How vaccines cause adverse events
Lessons learned and assessment of causal relationships
Safety monitoring during clinical trials
Workshop: Safety Monitoring Clinical Trials, adverse events and vaccines
Post marketing surveillance
Workshop on Post Marketing Surveillance and Safety Monitoring during clinical trials
Risk Management Planning
Signal detection in spontaneous reporting systems
Pharmacoepidemiological methods/signal substantiation
EPI approaches in global collaboration
Workshop: Public Vaccine Adverse Event Reporting System (VAERS) dataset, data extraction and calculation Proportional Reporting Ratio (PRR), Reporting Odds Ratios (RORs) using Excel
Quality, inspections
Regulations and role of QPPV
Wrap up and Q&A about the module
Crisis Management
Communication in Pharmacovigilance

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