Vaccine Safety and Pharmacovigilance - Programma

Module 1 | An introduction to Pharmacovigilance

• Welcome
• Introduction to Pharmacovigilance and Risk Management
• Principles of Pharmacovigilance
• How vaccines differ from drugs?
• Specificities of Vaccine Safety
• Discussion and Q&A

Module 2 | Vaccine Safety Regulations

• Classification of adverse events
• Regulations
• Vaccine safety in developing countries
• Discussion and Q&A

Module 3 | Vaccine Safety in Clinical Trials

• How vaccines cause adverse events
• Lessons learned and assessment of causal relationships
• Safety monitoring during clinical trials and safety elements of clinical trial elements
• Discussion and Q&A

Module 4 | Post Marketing Vaccine Surveillance

• Post marketing surveillance
• Workshop on Post marketing surveillance and safety during clinical trials
• Discussion and Q&A

Module 5 | Pharmacovigilance Methods

• Signal detection
• Risk management
• Pharmacoepidemiology
• Class exercises on PV methods
• Discussion and Q&A

Module 6 | The link between Quality and Safety

• Quality in pharmacovigilance
• Inspections
• Role of QPPV
• Discussion and Q&A

Module 7 | Crisis Management

• Crisis management
• Communication in pharmacovigilance
• Discussion and Q&A

Module 8 | Vaccine Vigilance Workshop

• The workshop will describe how AE Detection differs between drugs and vaccines, commonly expected reactions, SAEs, methods for detecting SAEs, size of vaccine studies, VAERS, AEFI (WHO), Brighton collaboration group, how to investigate Vaccine reactions.
• Real time example: Assessing the safety of Covid19 vaccines
• Discussion and Q&A
• Closing remarks