Cobert, Barton L. creator author. Gregory, William W. author. Thomas, Jean-Loup author. Baldridge, Catherine author. text bibliography Print books. si 2025 Fourth edition. monographic eng 504 pages illustrations, 29 cm. 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. by Barton Cobert, William W. Gregory, Jean-Loup Thomas, and Catherine Baldridge. Previous edition: 2019. Includes bibliographical references. Drugs Side effects Handbooks, manuals, etc Pharmacoepidemiology Handbooks, manuals, etc Pharmacovigilance Handbooks, manuals, etc Drug monitoring Risk management Drug-Related Side Effects and Adverse Reactions Pharmacoepidemiology Product Surveillance, Postmarketing Risk Management Pharmacovigilance Drug Monitoring Gestion du risque risk management RM302.5 .C63 2025 9789811297717 2025410063 YDX 240821 20260329115431.0 in00024277000 eng