First book that covers key pharmacovigilance issues from resource-limited countries
Includes case studies from different countries and focusses on special methodologies like active pharmacovigilance
A special chapter on unique methodological challenges with the conduct of vaccine safety studies
Guides the reader on training and funding opportunities in pharmacovigilance

Autorentext

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'.

Klappentext
Medical products have dramatically revolutionized how diseases are treated or prevented. At the same time, inappropriate use of these products is associated with increased incidence of adverse reactions. This problem is acute in resource-limited countries in the absence of adequate monitoring systems. This book examines and highlights the critical role and need for pharmacovigilance systems 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 levels; 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. This book is unique in its focus on pharmacovigilance in resource-limited countries. 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. Adel Al-Harf, Ph.D., Vice President of the Drug Sector, Saudi Food and Drug Authority (SFDA), Kingdom of Saudi Arabia 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 to train regulators and help establish pharmacovigilance centres. He has conducted pharmacovigilance training in Eswatini, Cambodia, Kuwait, Laos, Oman, the Philippines, Pakistan, Palestine, Saudi Arabia, and the UAE. Dr. Ahmad has contributed chapters on pharmacovigilance, and the FDA approval process in seven texts including the past editions of Brian Strom's 'Textbook of Pharmacoepidemiology' and Ronald Mann's 'Pharmacovigilance'.

Inhalt

1. Pharmacovigilance in Pakistan: A Neglected Link (Madeeha Malik, Azhar Hussain).- 2. Pharmacovigilance Situation in India: Issues and Challenges (J Vijay Venkatraman, Vignesh Rajendran and Ganesan Muniappan).- 3. Challenges and Opportunities for Pharmacovigilance Development in the Arab World (Danya M. Qato).- 4. What should be the Focus of Pharmacovigilance in the Pacific Island Countries? (John McEwen, Amanda L C Sanburg, Agnes Mathias, Lasse S Vestergaard).- 5. Pharmacovigilance and Public Health in Latin America Countries (Mónica Tarapués, Mariano Madurga).- 6. The Caribbean Network for Pharmacovigilance: Sharing Resources for Regional Vigilance (Rian Marie Extavour, Joy St John).- 7. The State of Pharmacovigilance in Brazil (Marcelo Vogler de Moraes and Yannie Silveira Gonçalves).- 8. What Signal Detection Means in a Small Database? - Case Reports from Cabo Verde (Veiga, Cálida Etezana Rodrigues).- 9. Pharmacovigilance Situation in Sierra Leone in the Light of the Ebola Crisis (Wiltshire C.N. Johnson, Onome T. Abiri).- 10. New Tuberculosis Drugs and the Role of Pharmacovigilance: Issues in Resource-limited Countries (EW. Tiemersma, S. van den Hof, M. Kimerling).- 11. The Public Health Issue of Falsified and Substandard Medicines in Resource-limited Settings (Céline Caillet and Paul N Newton).- 12. The Role of Pharmacovigilance Centers in Detecting Medication Errors: Moroccan Experience (Rachida Soulaymani Bencheikh, Loubna Alj, Ghita Benabdallah, Houda Sefiani).- 13. Pharmacovigilance Practices in Indian Systems of Medicine with Additional Highlights of its Concept in Unani Medicine (Syed Ziaur Rahman, Abdul Latif, Abdur Rauf, Sumbul Rehman).- 14. Vaccine Safety Issues in Resource-limited Countries (Daniel Weibel, Robert T. Chen, Osemeke Osokogu, Chioma Ejekam, Rebecca Chandler, Jyoti Joshi, Patrick Zuber, Steven Black, Silvia Perez-Vilar, Esperanca Sevene, Sammy Khagayi, Mandyam Ravi, Bruce Fireman, Laurence Baril, Sonali Kochhar, Jane Gidudu, Miriam Sturkenboom).- 15. Risk Perception and Communication in the Developing World (Bruce Hugman).- 16. Training and Capacity Building Opportunities in Pharmacovigilance (Karine Palin, Stéphane Liège, Christa Naboulet and Francesco Salvo).- 17. Pharmacy and Poisons Board: A Regional Centre of Regulatory Excellence (RCOREs) in Africa on Pharmacovigilance (Christabel Khaemba, Pamela Nambwa, Martha Mandale, Edward Abwao, Karim Wanga, Kariuki Gachoki, Fred M. Siyoi).- 18. KIDS-APEC Pharmacovigilance Center of Excellence Training (Euihwan Baek, E Na Song).- 19. Training and Capacity building Opportunities in Pharmacovigilance (Akiko Ogata).- 20. The UK MHRA's Collaboration to Improve Pharmacovigilance in Resource-Limited Settings (Mick Foy).- 21. Pragmatic Pharmacovigilance and Combatting Substandard and Falsified Medical Products (SFs) (Paul B. Huleatt).- 22. Thirty Years of Safety and Vigilance Systems Strengthening in the WHO AFRO Region: from Buoyant Growth to Rigorous Protection of Public Health (Stanislav Kniazkov).- 23. Institutional and Individual Capacity Building in Pharmacovigilance (Tamara Hafner and Francis Aboagye-Nyame).- 24. Proforma Consortium to Strengthen Pharmacovigilance Capacity in Africa (Eleni Aklillu).- 25. Strengthening Pharmacovigilance in Africa - Pharmaco Vigilance Africa (PAVIA) (Frank GJ Cobelens; Michelle Nderu).