Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition)

by Barton Cobert, William Gregory, Jean-loup Thomas

Overview

Completely revised and updated, Cobert's Manual of Drug Safety and Pharmacovigilance, Third Edition, is a how-to manual 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 (also known as pharmacovigilance), and provides essential information on drug safety and regulations in the United States, Europe Union, and more, including: recognizing, monitoring, reporting, and cataloging serious adverse drug reactions.Cobert's Manual of Drug Safety and Pharmacovigilance, Third 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.Related Link(s)

Product Details

ISBN-13:	9789811215230
Publisher:	World Scientific Publishing Company, Incorporated
Publication date:	05/30/2019
Pages:	524
Sales rank:	463,393
Product dimensions:	8.50(w) x 11.02(h) x 1.06(d)

Table of Contents

Basics The Theory and Definitions of Drug Safety (Pharmacoviligance); Spontaneous Postmarketing Adverse Events; Regulations, Directives, Guidances, and Laws; The Qualified Person for Pharmacovigilance; Children, Elderly, and Other Special (Vulnerable) Groups; Drug Interactions; Seriousness, Expectedness, and Causality; Signals and Signaling in the Context of Risk Management; Organization of a Typical Drug Safety Department; Ethical Issues and Conflicts of Interest; Vaccinovigilance; Data Privacy and Security; Real-World Issues: Fialuridine, Fen-Phen, Nomifensine; Marijuana; and other papers