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. Contents: The History and Theory of Drug Safety and Pharmacovigilance Primary Definitions relevant to Safety & Pharmacovigilance Regulations, Directives, Guidance, Laws and Consensus Documents The United States Food and Drug Administration The European Medicines Agency Council for International Organizations of Medical Sciences (CIOMS) International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) The Uppsala Monitoring Centre Biopharmaceutical Companies The Safety Department's Role in Cross-Functional Areas Organization of a Typical Drug Safety Department Clinical Trial Phases and Investigator-Initiated Trials Data Monitoring Committees and Investigational Review Boards/Ethics How an Individual Case Safety Report (ICSR) is Handled from Start to Finish Seriousness, Expectedness, and Causality Coding of Adverse Events and Drug Names Spontaneous Post-marketing Adverse Events Generics, Excipients, Placebos, and Counterfeits Artificial Intelligence and Pharmacovigilance Expedited and Aggregate Reporting in Clinical Trials Post-marketing Spontaneous ICSR/SAE Reporting Post-marketing Aggregate Safety Reporting The Mathematics of Adverse Events Pharmacoepidemiology: Its Practical Use in the World of Drug Safety Signals and Signaling in the Context of Risk Management Risk Assessment, Evaluation, Management, Mitigation, & Strategy Drug Interactions The Many Players in the World of Pharmacovigilance Pharmacovigilance System Master File The Qualified (Individual) Person(s) Responsible for Pharmacovigilance Product Labeling Business Partners and Exchange of Safety Data Where Data Reside Information Technology and the Safety Database Data Privacy and Security Children, Elderly, and Other Special (Vulnerable) Groups Acute and Chronic (Late Occurring) Adverse Events, Adverse Events That Disappear Pregnancy and Lactation Product Quality Issues Safety Data Volume, Archival, Record Retention, and Good Documentation Procedures PV Quality System Training Audits and Inspections Ethical Issues and Conflicts of Interest Universities and Academic Medical Centers Vaccinovigilance Real-World Issues: Case Studies Medical Marijuana and Pharmacovigilance 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. 'The original text, and 'founding father' of this textbook series, Dr Barton Cobert, has worked tirelessly over the years to share his knowledge, experience and insight in this scientific field. His contributions to the industry are well known and he was one of the first to set forth and publish a text regarding the basic principles and theory of drug safety and pharmacovigilance. Throughout his illustrious career, he has forged relationships with other key opinion leaders and graciously invited others to contribute their...
