06781cam a2200925 i 4500 ocn868511726 OCoLC 20171031134751.0 m o d cr ||||||||||| 140117s2014 enk ob 001 0 eng 2014002242 016697425 Uk 9781118820148 (ePub) 1118820142 (ePub) 9781118820179 (Adobe PDF) 1118820177 (Adobe PDF) 9781118820186 (electronic bk.) 1118820185 (electronic bk.) 0470671041 9780470671047 9780470671047 (cloth) DEBSZ 431662967 GBVCP 813902444 NZ1 15624996 NZ1 15920442 AU@ 000052429159 (OCoLC)868511726 (OCoLC)875820397 (OCoLC)878148990 (OCoLC)960202546 (OCoLC)961516735 (OCoLC)962726974 DLC eng rda pn DLC YDX MHW N$T DG1 CUS UKMGB YDXCP OCLCF NLGGC E7B CDX EBLCP DEBSZ COO OCLCQ OCLCO LOA DG1 pcc MAIN RM302.5 QV 771 BUS 032000 bisacsh SOC 000000 bisacsh 363.19/463 23 Pharmacovigliance. Mann's pharmacovigilance / edited by Elizabeth B. Andrews, Nicholas Moore. [electronic resource] Third edition. Chichester, West Sussex, UK ; Hoboken, NJ : Wiley Blackwell, 2014. 1 online resource. text txt rdacontent computer c rdamedia online resource cr rdacarrier Preceded by Pharmacovigilance / editors, Ronald D. Mann, Elizabeth B. Andrews. 2nd ed. c2007. Includes bibliographical references and index. Cover; Title page; Copyright page; Contents; Contributors; Foreword; 1: Introduction: Updated from Second Edition; Background; Diagnosing Adverse Drug Reactions; Current Methods of Pharmacovigilance; Hypothesis-Generating Methods; Spontaneous Adverse Drug Reaction Reporting; Prescription-Event Monitoring; Other Hypothesis-Generating Methods; Hypothesis-Testing Methods; Conclusion; References; 2: History of Pharmacovigilance; Early History of Drug Safety; Recent History; Pre-1962; Turning Point: The Federal Food, Drug and Cosmetics Act; Gradual Increase in Regulatory Authority. Tectonic Shift: ThalidomidePost-Thalidomide Evolution of Regulation; United States of America; United Kingdom; Germany; Scandinavia; Japan; World Health Organization; France; Special Issues in Pharmacovigilance; Examples of Drugs that were Withdrawn from the Market; Bendectin; Thalidomide: Today's Approved Uses; Pharmacovigilance is Not Just for Regulators; References; Part I: The Regulatory Basis of Pharmacovigilance; 3: Legal Basis: European Union; Introduction; Reorganization of the European Union Regulatory System. Obligations of being a Marketing Authorization Holder and being Granted a Marketing AuthorizationSignal Detection and Risk Management; Reporting Requirements; Transparency and Communication; Pharmacovigilance Enforcement; Further Information about Proposed New Legislation and Guidelines; 4: Ethical Oversight, Consent, and Confidentiality; Introduction; Practical Implications of Ethical Oversight; The Privacy and Security of Health Data; The Linkage of Electronic Health Data; The Conduct of Scientifically Sound Studies; Ethical Oversight and Privacy Law and Resulting Dilemmas; The Common Rule. State LawsThe Health Insurance Portability and Accountability Act; Dilemmas Arising from the Health Insurance Portability and Accountability Act; Directions for Future Ethical Oversight and Privacy Provisions; References; 5: Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation1; Introduction; The International Conference on Harmonisation Step Process; ICH Step 1: Development of Draft Consensus ICH Guideline or Recommendations; ICH Step 2: Confirmation of Six Party Consensus; ICH Step 3: Regulatory Consultation. ICH Step 4: Adoption of Tripartite ICH Guideline or RecommendationsICH Step 5: Implementation of ICH Guideline or Recommendations; Pharmacovigilance-Related International Conference on Harmonisation Topics; Topic ICH-E2A: Clinical Safety Data Management -- Definitions and Standards for Expedited Reporting; ICH-E2D Topic: Post-Approval Safety Management -- Definitions and Standards for Expedited Reporting; ICH-E2B Topic: Clinical Safety Data Management -- Data Elements for Transmission of Individual Case Safety Reports. ICH-E2C Topic: Clinical Safety Data Management -- Periodic Benefit-Risk Evaluation Report (PBRER). Mann's Pharmacovigilance is the definitive reference for the science of detection, assessment, understanding and prevention of the adverse effects of medicines, including vaccines and biologics. Pharmacovigilance is increasingly important in improving drug safety for patients and reducing risk within the practice of pharmaceutical medicine. This new third edition covers the regulatory basis and the practice of pharmacovigilance and spontaneous adverse event reporting throughout the world. Print version record and CIP data provided by publisher. Pharmacovigilance. Drug-Related Side Effects and Adverse Reactions classification. Internationality. Pharmacoepidemiology Methods. Product Surveillance, Postmarketing. Pharmacovigilance. Drug-Related Side Effects and Adverse Reactions classification. Internationality. Pharmacoepidemiology methods. Product Surveillance, Postmarketing. Drug-Related Side Effects and Adverse Reactions classification. Internationality. Pharmacoepidemiology methods. Pharmacovigilance. Product Surveillance, Postmarketing. BUSINESS & ECONOMICS Infrastructure. bisacsh SOCIAL SCIENCE General. bisacsh Pharmacoepidemiology. fast (OCoLC)fst01060242 Electronic books. Electronic books. Andrews, Elizabeth B., editor. Moore, Nicholas, editor. Print version: Third edition. Chichester, West Sussex, UK : John Wiley & Sons Inc., 2014 9780470671047 (DLC) 2014000062 http://onlinelibrary.wiley.com/book/10.1002/9781118820186 Wiley Online Library ddc BK 207215 207215