PROGRAM OUTLINE

Pharmacovigilance Short Course

Duration: 2 days

Audience:

• Medical affairs professionals
• Clinical Research professionals
• Clinical Safety staff
• Regulatory affairs personnel
• Research and Development teams
• Risk Management specialists
• Compliance specialists

Content:

• Introduction to PV
• Importance of AE reporting
• Process flow
• Sources of ADRs
• Causality and Expectedness
• Lack of Efficacy
• Expedited reporting
• The Pharmacovigilance system in India
• The PV regulations in EU
• Qualified Person for Pharmacovigilance (QPPV) requirements
• Development Safety Update Reports

On completion, participant will:

• Demonstrate an understanding of the importance of safety reporting
• Demonstrate an awareness of the correct reporting requirements that ensure patient safety
• Demonstrate an understanding of the roles and responsibilities of individuals responsible for safety reporting
• Demonstrate an ability to achieve timely submission of AE reports generated inhouse