Cobert's Manual of Drug Safety and Pharmacovigilance, Fourth Edition, is an updated how-to manual of guiding principles and concepts for those working in the fields of drug safety, clinical research, pharmacology, regulatory affairs, risk management, quality/compliance, and in government and legal professions. This comprehensive and practical guide discusses the theory and the practicalities of drug safety and pharmacovigilance, and provides essential information on drug safety and regulations in the United States, European Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions. Cobert's Manual of Drug Safety and Pharmacovigilance, Fourth Edition, teaches the daily practice of drug safety in industry, hospitals, the FDA and other health agencies - both in the United States and around the world - and provides critical information about what to do when confronted with a drug safety problem.