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 — Pharmacovigilance Clinical Trials, Clinical Research Organizations, Phases I–IV, and Investigator-Initiated Trials Spontaneous Post-marketing Adverse Events The Theory of Drug Safety — Pharmacovigilance The Mathematics of Adverse Events and a Brief Note on Pharmacoepidemiology Epidemiology and Pharmacoepidemiology: What Are They? What Are Their Limitations and Advantages? Regulations, Directives, Guidance, Laws and Consensus Documents The United States Food and Drug Administration The European Medicines Agency The EU Qualified Person for Pharmacovigilance The Uppsala Monitoring Centre Council for International Organizations of Medical Sciences Where Data Reside Information Technology, Databases, and Computers Adverse Events with New Chemical Entities, Generics, Excipients, Placebos, and Counterfeits Children, Elderly, and Other Special (Vulnerable) Groups Pregnancy and Lactation Acute and Chronic (Late Occurring) Adverse Events, Adverse Events That Disappear (Bendectin) and Diethylstilbesterol Drug Interactions Product Quality Issues AE Volume, Quality, Good Documentation Procedures, and Medical Records Seriousness, Expectedness, and Causality Coding of Adverse Events and Drug Names Expedited and Aggregate Reporting in Clinical Trials Post-marketing Spontaneous ICSR/SAE Reporting Periodic Adverse Drug Experience Reports, and Periodic Safety Update Reports/Periodic Benefit Risk Evaluation Reports Signals and Signaling in the Context of Risk Management Risk: What Is It? Risk Management and Assessment, Risk Evaluation and Mitigation Strategies, and Risk Management Plans Data Monitoring Committees and Investigational Review Boards/Ethics Committees Pharmaceutical Companies Organization of a Typical Drug Safety Department How an Individual Case Safety Report (ICSR) is Handled from Start to Finish PV Quality System Training Audits and Inspections Pharmacovigilance System Master File Ethical Issues and Conflicts of Interest The Safety Department's Role in Clinical Research, CROs, Marketing and Sales, Labeling, Regulatory, Quality, Due Diligence, Legal Issues, Toxicology, Epidemiology, Medical Information and Manufacturing Drug Labeling Universities and Academic Medical Centers Vaccinovigilance Business Partners and Exchange of Safety Data Data Privacy and Security The Roles and Interactions of Companies, Governments, Non-governmental Organizations, and Others in the World of Pharmacovigilance Real-World Issues: Case Studies Medical Marijuana and Pharmacovigilance International 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...
