Course description

Pharmacovigilance is an essential part of healthcare systems worldwide, focusing on monitoring and evaluating drug safety after approval. It explores the principles, practices, and regulations of pharmacovigilance to ensure safe and effective drug use.

In this comprehensive course, students will learn about the historical context and evolution of pharmacovigilance, its importance in public health and the pharmaceutical industry. They will study adverse drug reactions, their classification, detection methods, recording, and reporting. The course demonstrate:

1.     Data collection: Gathering relevant information.

2.     Signal management: Detecting potential safety signals.

3.     Risk management: Evaluating and managing risks.

4.     Risk/Benefit analysis: Balancing risks and benefits.

5.     Reporting different types of cases: Identifying reportable cases.

6.     Documents and records: Maintaining necessary documentation during and after pharmacovigilance processes.

Through case studies and practical examples, students will also understand the roles of various stakeholders, including regulatory bodies, pharmaceutical companies, healthcare professionals, and patients, in ensuring drug safety throughout the product lifecycle.

The course covers international and local pharmacovigilance regulations and requirements set by the Egyptian Drug Authority.

What will i learn?

• By the end of the course, participants will have a comprehensive understanding of pharmacovigilance principles and practices, enabling them to effectively assess drug safety, manage risks, and comply with regulations within the healthcare system