Pharmacovigilance Essentials

The book explores the field of pharmacovigilance, its historical context, along with its critical role in ensuring the safety of medications across the world. From its foundational principles to cutting-edge advancements and future challenges, this book provides a thorough understanding of the field's intricacies. The book begins by establishing the fundamentals of pharmacovigilance, emphasizing its significance in monitoring, detecting, assessing, and preventing adverse drug reactions (ADRs) that occur during the use of medications. Delving into the history of pharmacovigilance and regulatory actions, the book traces the evolution of the field, highlighting significant milestones and the establishment of regulatory frameworks that govern medication safety. It explores the pivotal role of regulatory authorities in develo** guidelines, regulations, and policies to safeguard public health. A significant aspect covered in the book is the processing of ADRs, providing insights into the steps involved in handling and evaluating ADR reports.  The book also addresses specialized areas within pharmacovigilance, including vaccine safety surveillance, herbovigilance (monitoring the safety of herbal medicines), materiovigilance (monitoring the safety of medical devices), and hemovigilance (ensuring the safety of blood products). Additionally, the book explores the role of pharmacogenetics in pharmacovigilance, highlighting how genetic factors influence individual responses to medications and how this knowledge can be integrated into safety monitoring and risk assessment. This book also covers databases used in pharmacovigilance across the globe, aggregate reporting and pharmacovigilance systems in EU and non-EU countries, and the role of artificial intelligence.

Finally, it emphasizes the need for continuous improvement, vigilance, and proactive measures to adapt to the changing healthcare landscape and address emerging safety concerns. The book serves as acomprehensive guide for healthcare professionals, researchers, regulators, and policymakers involved in pharmacovigilance.

Dr. Mukesh Nandave is an associate dean (research & development) and head of the Department of Pharmacology and pharmaceutical biotechnology at Delhi Pharmaceutical Sciences and Research University, Govt. of NCT of Delhi, New Delhi, India. He has earlier served as associate professor and head of the department of pharmacology at NMIMS University, Mumbai (2010-2017). He has also worked as a research scientist in the medical affairs and clinical research department of Ranbaxy Research Laboratories (currently known as Sun Pharmaceutical Industries Limited, Gurugram). Dr. Nandave earned his Ph. D. in pharmacology from AIIMS, Delhi and received his post-doctoral training from the Ohio State University Medical Center, Coohio, lumbus, USA.

For more than 20 years, Dr. Nandave has investigated the role of nutraceuticals, herbomineral formulations, and phytoconstituents for myocardial ischemia & reperfusion injury, diabetes, obesity, and pain management. He has published numerous papers in peer-reviewed national and international journals and various book chapters. His lab received more than 3.5 crore total funding from Govt. (DBT, DST, ICMR and AYUSH) as well as industry (Pharmazz, Dabur, Charak, Madhavbaug, Sandu).

Dr. Nandave has received numerous awards. He is secretary-general of the International Academy of Cardiovascular Sciences (IACS)-India section and treasurer of the Society for Promotion and Research of Cardiovascular Sciences (SPARCS). He is a life member of various professional bodies, including the International Society for Heart Research (ISHR), the International Academy of Cardiovascular Sciences (IACS), the Indian Pharmacological Society (IPS), the Indian Pharmaceutical Association (IPA), the Association of Physiologist and Pharmacologist of India (APPI); Association of Pharmaceutical Teachers of India (APTI), and Society for Ethnopharmacology.

Dr. Anoop Kumar currently working as an Assistant Professor in the Department of Pharmacology, Delhi Pharmaceutical Sciences & Research University (DPSRU), Govt. of NCT of Delhi, New Delhi, India. Earlier, he worked as an Assistant Professor and Head in the Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research (NIPER), Raebareli, and as an officiating Head and Associate Professor in the Department of Pharmacology, ISF College of Pharmacy, Moga, Punjab. He has also worked as a research scientist in the medical affairs and clinical research department of sun pharmaceutical industries limited, Gurugram, and Translational Health Science Institute (THSTI), Faridabad. He has completed his Ph.D. from Birla Institute of Technology, Mesra, Ranchi as a DST INSPIRE Fellow. He has also served as an expert member of the Board of Studies (BOS) of the Clinical Research Programme of IKGPTU, Jalandhar, Punjab (2019-2021) and Drug Discovery Hackathon 2020 joint initiative of AICTE, CSIR, and Govt. of India.

He has authored many research and review articles and a few book chapters in the International Journal and publishers of repute. He has also worked as member secretary of the Institutional Animal Ethics Committee (IAEC) and Animal House In-charge. Recently, he has also been included in top 2% list of scientists released by Stanford. His lab also gets funding from DST SERB SRG (30 lakhs), ICMR Mission Project (1.3 crores), and IIT-Delhi (10 lakhs). Dr. Anoop Kumar is Member Secretary of Institutional ethics Committee for Clinical trials and BA/BE studies at DPSRU and Treasurer of ISPOR India Chapter.