Global Pharmacovigilance Awareness

Pharmacovigilance is the process of monitoring the efficacy and safety profile of novel medications throughout their use in the healthcare system. The use of these medications in the heterogeneous population and uncontrolled environment will provide information concerning the side effects, adverse events, and interactions that could not have been unearthed during the clinical trials.

This course includes an introduction to the concept’ detailing its history and importance. It also emphasizes the need for global pharmacovigilance.

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

Lesson 1: What is Pharmacovigilance?

• Origin of Pharmacovigilance
• Scope of Pharmacovigilance

Lesson 2: Purpose of Pharmacovigilance

Lesson 3: Pharmacovigilance Systems

• Methods of Pharmacovigilance Systems
• Spontaneous Reporting
• Cohort Event Monitoring
• Targeted Clinical Investigations
• Comparison of Pharmacovigilance Methods

Lesson 4: Pharmacovigilance Case Processing

• Data Management
• Relationship Assessment Between Drug and Adverse Reaction
• Reporting to Appropriate Bodies

Lesson 5: Achieving Global Pharmacovigilance Awareness

• National Pharmacovigilance Centers
• Health Professionals
• Pharmaceutical Companies
• Patients and General Public
• WHO Monitoring Programs
• Challenges to Achieving Global Pharmacovigilance Awareness

Glossary

Conclusion

Quiz