LEADER 05820nam 2200793 450 001 9910139125403321 005 20200520144314.0 010 $a1-118-82018-5 010 $a1-118-82014-2 010 $a1-118-82017-7 035 $a(CKB)2550000001273075 035 $a(EBL)1662669 035 $a(SSID)ssj0001180106 035 $a(PQKBManifestationID)11651399 035 $a(PQKBTitleCode)TC0001180106 035 $a(PQKBWorkID)11185376 035 $a(PQKB)11636277 035 $a(OCoLC)878148990 035 $a(MiAaPQ)EBC1662669 035 $a(DLC) 2014002242 035 $a(Au-PeEL)EBL1662669 035 $a(CaPaEBR)ebr10856801 035 $a(CaONFJC)MIL595202 035 $a(OCoLC)875820397 035 $a(PPN)182464210 035 $a(EXLCZ)992550000001273075 100 $a20140412h20142014 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aMann's pharmacovigilance /$fedited by Elizabeth B. Andrews, Nicholas Moore ; Andrew Magee, cover design 205 $aThird edition. 210 1$aChichester, England :$cWiley Blackwell,$d2014. 210 4$dİ2014 215 $a1 online resource (876 p.) 300 $aPreceded by Pharmacovigilance / editors, Ronald D. Mann, Elizabeth B. Andrews. 2nd ed. c2007. 311 $a0-470-67104-1 311 $a1-306-63951-4 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $aCover; 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 327 $aTectonic 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Scandinavia; Japan; World Health Organization; France; Special Issues in Pharmacovigilance; Examples of Drugs that were Withdrawn from the Market; Bendectin; Thalidomide: Today's Approved Uses; Pharmacovigilance is Not Just for Regulators; References; Part I: The Regulatory Basis of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 327 $aObligations 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 327 $aState 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 327 $aICH 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 327 $aICH-E2C Topic: Clinical Safety Data Management - Periodic Benefit-Risk Evaluation Report (PBRER) 330 $a 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. It examines signal detection and analysis, including the use of population-based data 606 $aPharmacovigilance 606 $aDrug-Related Side Effects and Adverse Reactions$vclassification 606 $aInternationality 606 $aPharmacoepidemiology$vMethods 606 $aProduct Surveillance, Postmarketing 615 0$aPharmacovigilance. 615 0$aDrug-Related Side Effects and Adverse Reactions 615 0$aInternationality. 615 0$aPharmacoepidemiology 615 0$aProduct Surveillance, Postmarketing. 676 $a363.19/463 702 $aAndrews$b Elizabeth B. 702 $aMoore$b Nicholas 702 $aMagee$b Andrew 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910139125403321 996 $aMann's pharmacovigilance$91552091 997 $aUNINA