Learning outcomes

By the end of this course, students will be able to:

  1. Define pharmacovigilance and explain its importance in public health and drug regulation.
  2. Identify and describe the various types of adverse drug reactions (ADRs) and related terminology.
  3. Analyze real-world cases to evaluate causality between drugs and adverse events.
  4. Interpret and apply relevant pharmacovigilance legislation and guidelines, including Good Pharmacovigilance Practice (GVP) modules.
  5. Develop and present a structured guideline-based pharmacovigilance report (GVP guideline).
  6. Collaborate effectively in groups to assess risks and propose risk minimization strategies.
  7. Critically assess the benefit/risk balance of medicines across their lifecycle.


Goals

  • To introduce students to the fundamental principles and practices of pharmacovigilance.
  • To provide a comprehensive understanding of the European and international regulatory framework for drug safety.
  • To train students in the detection, assessment, understanding, and prevention of adverse drug réactions.
  • To prepare students for professional roles in regulatory affairs, clinical research, and public health through practical, case-based learning.


Content

Introduction to Pharmacovigilance

  • Definition, history, and importance of pharmacovigilance
  • Key concepts and terminology
  • Stakeholders and their roles in pharmacovigilance

Adverse Drug Reactions (ADRs)

  • Types and classification of ADRs (Type A, B, C, D)
  • Serious vs. non-serious ADRs
  • Expected vs. unexpected ADRs

Causality Assessment

  • WHO and Naranjo algorithm
  • CIOMS/RUCAM scale for drug-induced hepatotoxicity
  • Practical case analysis

Good Pharmacovigilance Practices (GVP)

  • Overview of GVP modules
  • Pharmacovigilance processes and systems
  • Roles of marketing authorization holders and regulatory agencies

Signal Detection and Risk Management

  • Signal detection methodologies (PRR and other statistical tools)
  • Risk minimization and communication strategies
  • Post-authorization safety studies (PASS)

Benefit/Risk Evaluation

  • Methods to assess benefit-risk balance
  • Case studies and practical examples

Pharmacovigilance Legislation and Guidelines

  • EU and international perspectives
  • Legal obligations for reporting ADRs


Table of contents

  1. Introduction to Pharmacovigilance
  2. Key Concepts, Definitions, and Terminology
  3. Types and Classification of ADRs
  4. Causality Assessment
  5. Good Pharmacovigilance Practices (GVP)
  6. Signal Detection and Risk Management
  7. Benefit/Risk Balance
  8. Pharmacovigilance Legislation and Regulatory Framework
  9. Case Studies and Group Work on GVP Guidelines
  10. Review and Exam Preparation


Teaching methods

The course will use a blended teaching approach combining:

  • Ex-cathedra lectures: To introduce key theoretical concepts.
  • Flipped classroom sessions: Students will work in groups to prepare and present a Good Pharmacovigilance Practice (GVP) guideline analysis.
  • Interactive discussions and case studies: To promote critical thinking and collaborative learning.


Assessment method

  • Final exam (written):
  • Open-book exam with open-ended questions.
  • Students will have access to course materials during the exam.
  • Group presentation:
  • Evaluation of teamwork and presentation of a GVP guideline during flipped classroom sessions.


Language of instruction

English