Full Description
Medicines Safety and Pharmacovigilance: Introduction, Concepts, and Applications provides a comprehensive guide for pharmaceutical professionals navigating the complex landscape of medicine safety and vigilance. Designed to support strategic decision-making, this reference draws on industry expertise to uphold the highest standards of patient care. The book addresses essential regulatory requirements, reporting obligations, and ethical considerations, offering practical guidance for implementing effective pharmacovigilance systems. Covering the latest technological advancements, it ensures readers are equipped to meet the modern challenges faced by healthcare and pharmaceutical sectors in monitoring the safety and efficacy of medicines for diverse populations worldwide.
Beyond the foundational concepts, the book presents detailed insights into signal detection, risk management plans, and the real-world application of pharmacovigilance through case studies from both high- and low-middle-income countries. It examines the pivotal role of pharmacists and the importance of tailored approaches for special populations, while emphasizing effective communication of medicines safety.
Contents
1. Introduction to medicines safety and pharmacovigilance
2. Regulatory framework for pharmacovigilance
3. Healthcare professionals' experiences and expectations with regards to medicines safety
4. Safety surveillance methods
5. Signal detection and management
6. Risk management plans
7. Medicines safety system: case studies from high income countries
8. Medicines safety system: case studies from low and middle income countries
9. Medicines safety and the role of the pharmacists
10. Pharmacovigilance in special populations
11. Communicating medicines safety: A global interface
12. Ethical considerations in pharmacovigilance
13. Technology in pharmacovigilance
14. Advancing medicines safety science through public-private partnerships
15. Future directions in pharmacovigilance
16. Causality assessment methods in pharmacovigilance
17. Pharmacovigilance in clinical trials and advanced therapies
18. Insights from the Industry in pharmacovigilance
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