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Pharmacovigilance is a science used to describe the processes for monitoring and evaluating ADRs-is a key component of effective drug regulation systems, clinical practice and public health programs. The principal concern of pharmacovigilance is the detection of ADRs in real world clinical trial that are novel by virtue of their clinical nature, severity and/or frequency as soon as possible with minimum patient exposure. The scope of pharmacovigilance needs to be extended beyond the strict confines of detecting new signals of safety concerns. This book Textbook of Pharmacovigilance is an compilations of all the theoretical and practical aspects of pharmacovigilance, for easy accessibility to any new entrant in the field and serve as a ready reference for those actively involved in the area. The book includes basic definitions, classifications, objectives and elaborates the practical aspects including setting up of pharmacovigilance center, regulations in various countries, data mining, risk-benefit assessment, etc. It also provides recent updates on key issues from US FDA, MHRA and other health authorities. It's like a thorough reference book for all the drug safety professionals.
A propos de l'auteur
Skilled, hard-working and meticulous drug safety professional, with contribution in developing and performing all aspects of safety management. Has been globally and domestically responsible for implementing and and following USFDA, ICH guidelines, EMEA/EU regulations. Fully compliant with timelines, report submissions, review of source documents.
