This book from Jaypee Brothers Medical Publishers is an English medium (अंग्रेजी माध्यम) book on Pharmacovigilance, written by Himanshu Baweja with forewords by Sangeeta Sharma and Yatin Mehta, prepared for postgraduate students of pharmacology and pharmacy, drug safety and clinical research professionals, and also useful for MBBS, BDS and nursing students who must understand adverse drug reaction reporting as part of the competency-based curriculum. The book explains the discipline as it is actually practised — why a drug's safety profile cannot be complete at the time of approval, and how the systems of post-marketing surveillance find, verify and act on the harms that appear only when a medicine reaches large populations. It covers the history and principles of pharmacovigilance, the classification and mechanisms of adverse drug reactions (प्रतिकूल औषधि प्रभाव), spontaneous reporting and the problem of under-reporting, causality assessment using the WHO-UMC and Naranjo scales, seriousness and expectedness criteria, individual case safety reports and their processing, MedDRA coding and safety databases, signal detection and data mining, periodic safety update reports, risk management plans and risk minimisation measures, medication errors and drug interactions, pharmacovigilance in special populations, vaccine safety and AEFI, the Pharmacovigilance Programme of India (PvPI) and the CDSCO framework, and the ICH, WHO and international regulatory guidelines that govern the field. Its distinguishing feature is the practical orientation — reporting forms, worked case examples and assessment scales presented in the form in which they are used at an ADR monitoring centre. All content, terminology and explanations in this book are presented in the English language only. Key Features: English medium book — complete content, terminology and explanations in English Written by Himanshu Baweja, published by Jaypee Brothers Medical Publishers Forewords by Sangeeta Sharma and Yatin Mehta Practical orientation with reporting forms, case examples and assessment scales Indian regulatory framework covered alongside international guidelines Written for pharmacology and pharmacy postgraduates and drug safety professionals Also useful for MBBS, BDS and nursing students for ADR reporting competencies Diagrams, flowcharts and tables for quick reference History, principles and scope of pharmacovigilance Classification, mechanisms and predisposing factors of adverse drug reactions Spontaneous reporting systems and causes of under-reporting Causality assessment using WHO-UMC and Naranjo scales Seriousness, expectedness and severity assessment criteria Individual case safety reports and case processing workflow MedDRA coding and pharmacovigilance safety databases Signal detection, data mining and signal management Periodic safety update reports and post-marketing surveillance studies Risk management plans and risk minimisation measures Medication errors, drug interactions and drug-induced organ toxicity Pharmacovigilance in pregnancy, paediatrics, geriatrics and other special populations Vaccine safety and adverse events following immunisation (AEFI) Pharmacovigilance Programme of India (PvPI) and the CDSCO framework ICH, WHO and international regulatory guidelines Useful for postgraduate examinations, professional certification and practice in drug safety Pharmacology एवं Pharmacy के स्नातकोत्तर विद्यार्थियों तथा drug safety व clinical research professionals के लिए Jaypee Brothers Medical Publishers द्वारा प्रकाशित यह "Essentials of Pharmacovigilance" पुस्तक Himanshu Baweja द्वारा लिखी गई है तथा इसकी प्रस्तावना Sangeeta Sharma एवं Yatin Mehta द्वारा दी गई है; यह MBBS, BDS एवं नर्सिंग विद्यार्थियों के लिए भी उपयोगी है। इसमें pharmacovigilance के सिद्धांत, प्रतिकूल औषधि प्रभावों का वर्गीकरण, spontaneous reporting, WHO-UMC एवं Naranjo scales द्वारा causality assessment, case processing एवं MedDRA coding, signal detection, PSUR, risk management plans, medication errors, विशेष जनसंख्या में pharmacovigilance, vaccine safety एवं AEFI तथा PvPI, CDSCO, ICH व WHO गाइडलाइंस को reporting forms, चित्रों एवं तालिकाओं सहित समझाया गया है। सम्पूर्ण पुस्तक अंग्रेजी माध्यम (English medium) में है, इसमें हिंदी माध्यम की सामग्री सम्मिलित नहीं है।