Special Issues in Pharmacovigilance in Resource-Limited Countries

Couverture
Syed Rizwanuddin Ahmad
Springer Nature, 30 sept. 2025 - 377 pages

Examining the state of pharmacovigilance systems in resource-limited countries, this book addresses the critical role that pharmacovigilance systems play, as drugs and vaccines become increasingly accessible in these settings. Issues unique to these countries are explored, including medical product safety and quality problems, the nature of support needed to build pharmacovigilance system capacity to effective level, global and regional strategies and efforts to develop institutional and professional capacity; the challenges being faced and how these are being tackled.
This book is a must-read resource for anyone involved in the provision of safe, and quality medical products; and its rational use in resource-limited settings, including staff of pharmacovigilance centers, regulatory authorities, academia, contract research organizations, the pharmaceutical industry, donor agencies and technical assistance providers.

This book is unique in its focus on pharmacovigilance in resource-limited countries (RLCs). Many RLCs face serious challenges in maintaining health care systems, ensuring access to essential medicines and promoting drug safety. The editor has built an exceptional and well-balanced pharmacovigilance compendium. The individual chapters by experts provide a valuable resource of national and regional pharmacovigilance experiences. A very good read not only for pharmacovigilance professionals in RLCs, but also for donors and other international organisations.
Hubert G Leufkens, PhD, FISPE, Professor of Pharmaceutical Policy
and Regulatory Science, Utrecht Institute for Pharmaceutical Sciences (UIPS),
Former Head of the Dutch regulatory agency (MEB), The Netherlands

I foresee this collection will become a very useful reference for everyone working or supporting the development of pharmacovigilance in countries with limited resources. We have utilized the services of Dr. Ahmad on several occasions. His passion and focus on important issues resonates throughout the book.
Adel Al-Harf, PhD, Vice President of the Drug Sector,
Saudi Food and Drug Authority (SFDA), Kingdom of Saudi Arabia

 

Table des matières

Pharmacovigilance in Pakistan A Neglected Link
1
Pharmacovigilance Situation in India Issues and Challenges
8
Challenges and Opportunities for Pharmacovigilance Development in the Arab World
33
What Should Be the Focus of Pharmacovigilance in the Pacific Island Countries?
56
Pharmacovigilance and Public Health in Latin America Countries
67
Caribbean Network for Pharmacovigilance Sharing Resources for Regional Vigilance
72
The State of Pharmacovigilance in Brazil
79
What Signal Detection Means in a Small Database? Case Reports from Cabo Verde
87
Vaccine Safety Issues in ResourceLimited Countries
211
Risk Perception and Communication in the Developing World
249
Training and Capacity Building Opportunities in Pharmacovigilance
324
Pharmacy and Poisons Board A Regional Centre of Regulatory Excellence RCORE in Africa on Pharmacovigilance
335
KIDSAPEC Pharmacovigilance Center of Excellence Training
341
PMDAs Training and Capacity Building in Pharmacovigilance
345
The UK MHRAs Collaboration to Improve Pharmacovigilance in ResourceLimited Settings
348
Pragmatic Pharmacovigilance and Combatting Substandard and Falsified Medical Products SFs
353

Pharmacovigilance Situation in Sierra Leone in the Light of the Ebola Crisis
97
New Tuberculosis Drugs and the Role of Pharmacovigilance Issues in ResourceLimited Countries
117
The Public Health Issue of Falsified and Substandard Medicines in ResourceLimited Settings
145
The Role of Pharmacovigilance Centres in Detecting Medication Errors Moroccan Experience
179
Pharmacovigilance Practices in Indian Systems of Medicine with Additional Highlights of Its Concept in Unani Medicine
196
Thirty Years of Safety and Vigilance Systems Strengthening in the WHO AFRO Region From Buoyant Growth to Rigorous Protection of Public Health
357
Institutional and Individual Capacity Building in Pharmacovigilance
361
PROFORMA Consortium to Strengthen Pharmacovigilance Capacity in Africa
365
Strengthening Pharmacovigilance in Africa PhArmacoVigilance Africa PAVIA
372
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À propos de l'auteur (2025)

Dr. Ahmad is a drug safety consultant who served the U.S. FDA for 15 years. He received his medical degree from Dow Medical College, Karachi; public health degree from Johns Hopkins, Baltimore, and did clinical pharmacology fellowship at Georgetown University, Washington, DC.
Dr. Ahmad has a passion for teaching pharmacovigilance. He has conducted training in Eswatini, Cambodia, Kuwait, Laos, Oman, the Philippines, Pakistan, Palestine, Saudi Arabia, and the UAE.

He has contributed chapters in pharmacovigilance and the FDA approval process in seven textbooks including the past editions of Brian Strom’s textbook on ‘Pharmacoepidemiology’ and Ron Mann’s textbook on ‘Pharmacovigilance’.

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