Monitoring and ensuring drug safety is a vital responsibility in healthcare. This book introduces the principles of pharmacovigilance, including adverse drug reaction (ADR) reporting, signal detection, causality assessment, and risk management planning. It discusses the role of national and global surveillance systems, such as WHO-UMC and FDA MedWatch, and tools like benefit-risk analysis. Practical examples help pharmacists recognize, report, and analyze drug-related problems effectively. The content supports the development of safe pharmacotherapy practices and a culture of patient safety.
Bea Santos is a regulatory affairs expert with a primary focus on post-marketing surveillance and risk management of pharmaceutical products. With over 15 years in the field, she has contributed to international pharmacovigilance systems, authored safety signal reports, and collaborated with global health agencies. Her publications highlight adverse event tracking methodologies and benefit-risk evaluation frameworks. Bea is also a dedicated educator, conducting professional training programs on regulatory compliance and pharmacovigilance audits. Her expertise extends across multiple therapeutic categories, ensuring medication safety remains at the forefront of healthcare delivery.