Overview:

This advanced course delves into the methodologies and principles of causality assessment in Pharmacovigilance, equipping learners with the knowledge and skills to determine the relationship between a drug and an adverse event. By combining theoretical understanding with hands-on exercises, learners will gain expertise in applying causality assessment methods to real-world cases, focusing on accurate reporting and compliance with regulatory standards.

Objectives:

1. To understand various methods and tools used for causality assessment in PV.
2. To explore factors such as temporal relationship, dechallenge/rechallenge, and biological plausibility that influence causality determination.
3. To learn the reporting criteria and requirements for cases based on causal relationships.
4. To develop practical skills through case studies and hands-on training in causality assessments.

Outcomes:

By the end of this course, learners will:

• Have an in-depth understanding of causality assessment methods and their applications.
• Be proficient in evaluating the relationship between drugs and reported adverse events.
• Demonstrate the ability to apply technical concepts in real-world case scenarios.
• Understand the regulatory requirements for reporting based on causality outcomes.
• Develop the confidence to handle complex cases requiring detailed causality assessments.

Hands-On Training Components:

1. Real-World Case Simulations:
• Practice performing causality assessments using anonymized real-world ICSRs.
• Apply causality scales like the WHO-UMC and Naranjo Algorithm to determine relationships.

Skills You Will Gain:

• Methodology Mastery: Proficiency in using WHO-UMC, Naranjo, and other causality scales.
• Critical Thinking: Ability to assess and interpret case details for causality determination.
• Regulatory Knowledge: Understanding global requirements for reporting based on causality.
• Practical Expertise: Experience handling diverse case scenarios, including complex and special situations.