The second edition of the textbook retains the similar style but with expanded contents. It deals with all aspects ranging from concept to practice of pharmacovigilance. It covers the historical background in the evolution of this emerging science, India’s and global scenario, science of pharmacovigilance, and pharmacovigilance of Indian system of medicine. The outstanding features are:· Written in easy understandable style.· Updated India’s PV Regulation· Case studies on drug withdrawal and causality analysis.· Key messages giving the gist of each chapter.In brief the book is all about learning, developing competencies, practicing and building career in safety monitoring of medicines.Contents:1. Introduction2. Pharmacovigilance in India3. Methods in Pharmacovigilance4. Adverse Drug Reactions: Classification, Mechanisms and Susceptibility5. Assessment of Adverse Events’ Reports6. Signal: Identification and Strengthening7. Quality Assurance in Pharmacovigilance8. Periodic Safety Update Reports9. Pharmacogenetics in Pharmacovigilance10. Ethical Consideration in Pharmacovigilance11. Global Scenario in Pharmacovigilance12. Pharmacovigilance of Ayurveda,Siddha, Unani and Homeopathic Drugs13. Materiovigilance in India14. Haemovigilance in India15. Pharmacovigilance of Vaccines16. Case Studies on Drugs Withdrawal17. Case Studies on Causality AssessmentAbout the Authors:Guru Prasad Mohanta, a former WHO officer, is currently with Annamalai University as Professor and Head of Department Pharmacy. He has more than 34 years of teaching, research and administrative experience at various levels with around 500 articles to his credit. He is a regular columnist for Newspapers and Pharma Magazines. He has authored several popular texts and reference books. With his International Training background he has been advocating the rational use of medicines at various forums. He has completed projects supported by UGC, ICMR, HAI-AP, EPN, CDSCO, and WHO. He was the Coordinator of Peripheral Centre under National Pharmacovigilance Programme supported by World Bank. He is associated with several Indian Universities and Institutions either as member of academic bodies or examiners. He is a member of various National and International Professional Bodies. He is a trainer in medicine supply chain management, pharmacoeconomics and rational use related areas. He has delivered more than 150 guest lectures in various forums. He is the recipient of the best researcher award of Annamalai University in 2012 and IAPST Pharmaceutical Scientist of the Year 2015 Award. Prabal Kumar Manna is Professor and Former Head of the Department of Pharmacy of Annamalai University. He has been trained on Pharmaceutical Technology at the University of Ghent, Belgium, with support of BADC Scholarship. He was recipient of the best Teacher Award 2011 of Annamalai University. He has more than 35 years of teaching, research and administrative experience at various levels with over 100 scientific publications to his credit. He has completed projects supported by UGC, ICMR, HAI-AP, EPN, CDSCO, and WHO. He is associated with several Indian Universities and Institutions either as member of academic bodies or examiners. He is a member of various National Professional Bodies.He has coordinated many continuing professional development programmes for pharmacy teachers and professional pharmacists. He was the Coordinator of Peripheral Centre under World Bank supported National Pharmacovigilance Programme.

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