Medicines Safety and Pharmacovigilance
Introduction, Concepts, and Applications
- 1st Edition - March 1, 2026
- Editor: Rabia Hussain
- Language: English
- Paperback ISBN:9 7 8 - 0 - 4 4 3 - 2 6 5 8 8 - 4
- eBook ISBN:9 7 8 - 0 - 4 4 3 - 2 6 5 8 9 - 1
Medicines safety and pharmacovigilance: introduction, concepts, and applications is a reference offering pharmaceutical scientists a strategic roadmap to navigate the intric… Read more
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Medicines safety and pharmacovigilance: introduction, concepts, and applications is a reference offering pharmaceutical scientists a strategic roadmap to navigate the intricate world of medicine safety and vigilance, harnessing the expertise of professionals and ensuring the highest standards of patient care. This book helps assist key stakeholders with implementation and regulatory requirements, including reporting obligations, ethics, and communication about medicines safety. It also provides an overview of signal detection and risk management in healthcare settings. Importantly, this book covers latest information about recent technology advancements required for the modern-day needs of pharmacovigilance. The contents of the book include an introduction to pharmacovigilance, the regulatory framework for pharmacovigilance, healthcare professionals' experiences and expectations, safety surveillance methods, signal detection and management, risk management plans, case studies from high and low-middle-income countries, the role of pharmacists, pharmacovigilance in special populations, communicating medicines safety, ethical considerations, public-private partnerships, and future directions in pharmacovigilance. The role of digital health technology, more clearly big data and artificial intelligence in the field is also comprehensively covered in a dedicated chapter. Medicines safety and pharmacovigilance: introduction, concepts, and applications serves as an indispensable resource for pharma researchers, healthcare professionals, and policymakers, providing a thorough understanding of medicines safety and pharmacovigilance principles, methods, and applications. In an era marked by evolving technological landscapes and healthcare challenges, this book equips its readers to navigate the dynamic field of pharmacovigilance with confidence.
- Provides evidence-based practices in pharmacovigilance
- Offers a comprehensive overview of medicines safety issues, such as adverse drug reactions, drug interactions, and medication errors
- Describes the methods and tools used for safety monitoring, signal detection methods, data management, and observational studies in pharmacovigilance
Professionals and researchers in the fields of pharmacology, pharmacy, medicine, nursing, public health, and regulatory sciences with varying levels of their care.
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
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
- Edition: 1
- Published: March 1, 2026
- Language: English
RH
Rabia Hussain
Dr. Rabia Hussain is a Senior Lecturer at the School of Pharmaceutical Sciences, Universiti Sains Malaysia, located in Penang. She is a renowned researcher in the field of medicine safety, pharmacovigilance, medication adherence, and clinical pharmacy. Her research has been published in high-impact journals and focuses on pharmacovigilance, research methods in pharmacy practice, clinical pharmacy, and issues related to medicines use.
Dr. Hussain has collaborated with ReAct - Action on Antibiotic Resistance and Health Action International, Asia Pacific, to improve the use of antibiotics. She is the Section Editor for the Journal of Pharmaceutical Policy and Practice (JoPPP) and has edited "Encyclopaedia of Evidence in Pharmaceutical Public Health and Health Services Research in Pharmacy (Elsevier)". Dr. Hussain is a fellow of the Royal Society for Public Health, and she has been nominated as the Apex Young Scholar by Universiti Sains Malaysia.
Affiliations and expertise
Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia