Cobert's Manual of Drug Safety and Pharmacovigilance (English Edition)

Cobert's Manual of Drug Safety and Pharmacovigilance (English Edition)

Bücher Details

  • Titel:Cobert's Manual of Drug Safety and Pharmacovigilance (English Edition)
  • Dateiname: cobert-s-manual-of-drug-safety-and-pharmacovigilance-english-edition.pdf
  • ISBN: 103682B07QV19LYP
  • Datum des Hochladens: 2020-01-15
  • Anzahl der Seiten: 434 Seiten
  • Autor: Barton Cobert/William W Gregory/Jean-Loup Thomas
  • Verlag: Barton Cobert/William W Gregory/Jean-Loup Thomas


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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 Centers

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