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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. Contents: The Theory and Definitions of Drug Safety — PharmacovigilanceClinical Trials, Clinical Research Organizations, Phases I–IV, and Investigator-Initiated TrialsSpontaneous Post-marketing Adverse EventsThe Theory of Drug Safety — PharmacovigilanceThe Mathematics of Adverse Events and a Brief Note on PharmacoepidemiologyEpidemiology and Pharmacoepidemiology: What Are They? What Are Their Limitations and Advantages?Regulations, Directives, Guidance, Laws and Consensus DocumentsThe United States Food and Drug AdministrationThe European Medicines AgencyThe EU Qualified Person for PharmacovigilanceThe Uppsala Monitoring CentreCouncil for International Organizations of Medical SciencesWhere Data ResideInformation Technology, Databases, and ComputersAdverse Events with New Chemical Entities, Generics, Excipients, Placebos, and CounterfeitsChildren, Elderly, and Other Special (Vulnerable) GroupsPregnancy and LactationAcute and Chronic (Late Occurring) Adverse Events, Adverse Events That Disappear (Bendectin) and DiethylstilbesterolDrug InteractionsProduct Quality IssuesAE Volume, Quality, Good Documentation Procedures, and Medical RecordsSeriousness, Expectedness, and CausalityCoding of Adverse Events and Drug NamesExpedited and Aggregate Reporting in Clinical TrialsPost-marketing Spontaneous ICSR/SAE ReportingPeriodic Adverse Drug Experience Reports, and Periodic Safety Update Reports/Periodic Benefit Risk Evaluation ReportsSignals and Signaling in the Context of Risk ManagementRisk: What Is It? Risk Management and Assessment, Risk Evaluation and Mitigation Strategies, and Risk Management PlansData Monitoring Committees and Investigational Review Boards/Ethics CommitteesPharmaceutical CompaniesOrganization of a Typical Drug Safety DepartmentHow an Individual Case Safety Report (ICSR) is Handled from Start to FinishPV Quality SystemTrainingAudits and InspectionsPharmacovigilance System Master FileEthical Issues and Conflicts of InterestThe Safety Department's Role in Clinical Research, CROs, Marketing and Sales, Labeling, Regulatory, Quality, Due Diligence, Legal Issues, Toxicology, Epidemiology, Medical Information and ManufacturingDrug LabelingUniversities and Academic Medical CentersVaccinovigilanceBusiness Partners and Exchange of Safety DataData Privacy and SecurityThe Roles and Interactions of Companies, Governments, Non-governmental Organizations, and Others in the World of PharmacovigilanceReal-World Issues: Case StudiesMedical Marijuana and PharmacovigilanceInternational Council for Harmonisation (ICH) Readership: Students, Medical professionals and others working in the field of pharmaceuticals. Physicians, nurses, pharmacists, PharmDs, PhDs, podiatrists, dentists, clinical researchers. In particular those who are involved in the safety and efficacy of drugs both in research and already on the market.Drugs;Side Effects;Adverse Reactions;Adverse Drug Reactions;Adverse Drug Effects;Adverse Drug Experiences;Toxicity;Drug Toxicity;Drug Safety;Safety00

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