{"product_id":"manns-pharmacovigilance-9780470671047","title":"Manns Pharmacovigilance","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003eHighly Commended at the BMA Medical Book Awards 2015  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.\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTrade Review\u003c\/b\u003e\u003cbr\u003e\u003cp\u003e“I highly recommend this comprehensive reference for everyone who has any role in developing, delivering, or regulating drugs, or educating prescribers to administer these drugs to patients so that drug therapy can maximize efficacy in treating diseases while minimizing adverse events.”  \u003ci\u003e (Doody’s\u003c\/i\u003e, 9 January 2015)\u003cbr\u003e\u003cbr\u003eHighly Commended at the BMA Medical Book Awards 2015\u003c\/p\u003e\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\u003e\u003cp\u003eContributors xi\u003c\/p\u003e \u003cp\u003eForeword xxi\u003c\/p\u003e \u003cp\u003e1 Introduction: Updated from Second Edition 1\u003cbr\u003e \u003ci\u003eRonald D. Mann and Elizabeth B. Andrews\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e2 History of Pharmacovigilance 11\u003cbr\u003e \u003ci\u003eJudith K. Jones and Elyse Kingery\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eI The Regulatory Basis Of Pharmacovigilance\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e3 Legal Basis: European Union 27\u003cbr\u003e \u003ci\u003eBrian Edwards, Calvin Johnson, and Shelley Gandhi\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 Ethical Oversight, Consent, and Confi dentiality 37\u003cbr\u003e \u003ci\u003eSuzanne L. West and Wendy A. Visscher\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Pharmacovigilance-Related Topics at the Level of the International Conference on Harmonisation 47\u003cbr\u003e \u003ci\u003ePriya Bahri\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e6 The Council for International Organizations of Medical Sciences Working Groups and Their Contributions to Pharmacovigilance 63\u003cbr\u003e \u003ci\u003eGunilla Sjölin-Forsberg and William Gregory\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Terminologies in Pharmacovigilance 77 \u003cbr\u003e \u003ci\u003eElliot Brown and Daniel von Sydow\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 Nonclinical Toxicological Support for Phase I Trials 95\u003cbr\u003e \u003ci\u003eDavid R. Jones and James W. MCBlane\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 The Evaluation of Adverse Events in Clinical Trials (with a Particular Focus on the Use of Meta Analysis) 109\u003cbr\u003e \u003ci\u003eJesse A. Berlin, Brenda Crowe, and H. Amy Xia\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 Case Reports as Evidence in Pharmacovigilance 121\u003cbr\u003e \u003ci\u003eJeffrey K. Aronson\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 Periodic Safety Update Reports 139\u003cbr\u003e \u003ci\u003ePatrice Verpillat and Mondher Toumi\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e12 The Principles behind Risk Management in the European Union 153\u003cbr\u003e \u003ci\u003eStella C.F. Blackburn and June M. Raine\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eII Pharmacovigilance Systems\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePharmacovigilance in Europe\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e13a Regulatory Pharmacovigilance in the European Union 173\u003cbr\u003e \u003ci\u003ePriya Bahri and Peter Arlett\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13b Spontaneous Reporting: United Kingdom 185\u003cbr\u003e \u003ci\u003eMick Foy, Paul Barrow, and June M. Raine\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13c Spontaneous Reporting: France 203\u003cbr\u003e \u003ci\u003eJacques Caron, Sophie Gautier, and Michel Mallaret\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13d How Pharmacovigilance is Organized in Germany 207\u003cbr\u003e \u003ci\u003eUlrich Hagemann and Norbert Paeschke\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13e Organization of Pharmacovigilance in the Netherlands 213\u003cbr\u003e \u003ci\u003eEugène Van Puijenbroek and Kees Van Grootheest\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13f Pharmacovigilance in Spain 217\u003cbr\u003e \u003ci\u003eDolores Montero, Miguel Angel Maciá, and César De La Fuente\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13g Italian Pharmacovigilance System 221\u003cbr\u003e \u003ci\u003eLaura Sottosanti and Fernanda Ferrazin\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13h Pharmacovigilance in Turkey 225\u003cbr\u003e \u003ci\u003eSinem Ezgi Gülmez\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePharmacovigilance in the Americas\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e14a Spontaneous Reporting and Pharmacovigilance Practice: USA 229\u003cbr\u003e \u003ci\u003eMin-Chu Chen, Solomon Iyasu, Alfred Sorbello, and Linda Scarazzini\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14b Spontaneous Reporting in Mexico 241\u003cbr\u003e \u003ci\u003eAlejandra Rosete and Ricardo Benítez-Vázquez\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14c Pharmacovigilance in Argentina: A Lot Done, A Lot To Do 245\u003cbr\u003e \u003ci\u003eLuis Alesso and Raquel Herrera Comoglio\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePharmacovigilance in Asia\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e15a Pharmacovigilance and Risk Management in Japan 249\u003cbr\u003e \u003ci\u003eKiyoshi Kubota and Tsugumichi Sato\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15b Pharmacovigilance in Hong Kong 259\u003cbr\u003e \u003ci\u003eThomas Y.K. Chan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15c Pharmacovigilance in China 263\u003cbr\u003e \u003ci\u003eHong-Hao Zhou, Fan-Dian Zeng, and Jie Tang\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15d China 267\u003cbr\u003e \u003ci\u003eKenneth Hartigan-Go and Althea Bongat\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15e Malaysia 271\u003cbr\u003e \u003ci\u003eKenneth Hartigan-Go and Althea Bongat\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15f Philippines 273\u003cbr\u003e \u003ci\u003eKenneth Hartigan-Go and Althea Bongat\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15g Singapore 277\u003cbr\u003e \u003ci\u003eKenneth Hartigan-Go and Althea Bongat\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15h Thailand 279\u003cbr\u003e \u003ci\u003eKenneth Hartigan-Go and Althea Bongat\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15i Vietnam 283\u003cbr\u003e \u003ci\u003eKenneth Hartigan-Go and Althea Bongat\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15j Pharmacovigilance in India 285\u003cbr\u003e \u003ci\u003ePipasha Biswas\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePharmacovigilance in New Zealand and Australia\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e16a Pharmacovigilance in New Zealand 291\u003cbr\u003e \u003ci\u003eMira Harrison-Woolrych, Michael Tatley, and Desiree Kunac\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16b Pharmacovigilance: Australia 295\u003cbr\u003e \u003ci\u003eJohn MCEwen\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePharmacovigilance in Africa\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e17 Pharmacovigilance in Africa 299\u003cbr\u003e \u003ci\u003eAlexander N.O. Dodoo and Haggar H. Ampadu\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eIII Signal Detection\/Generation in Spontaneous Reporting\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003ePrograms and Other Sources: From Spontaneous Reporting To Pharmacoepidemiology\u003c\/p\u003e \u003cp\u003e18 Vaccine Safety Surveillance 305\u003cbr\u003e \u003ci\u003eEmily Jane Woo, Jerry Labadie, and M. Miles Braun\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19 How We Assess Causality 319\u003cbr\u003e \u003ci\u003eJudith K. Jones and Elyse Kingery\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20 Quantitative Signal Detection and Analysis in Pharmacovigilance 331\u003cbr\u003e \u003ci\u003eAndrew Bate, Antoine Pariente, Manfred Hauben, and Bernard Bégaud\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21 Self-Controlled Case Series Analysis 355\u003cbr\u003e \u003ci\u003ePaddy Farrington\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22 Prescription–Event Monitoring (PEM): The Evolution to the New Modifi ed PEM and its Support of Risk Management 359\u003cbr\u003e \u003ci\u003eDeborah Layton and Saad Shakir\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23 Prescription–Event Monitoring in New Zealand 385\u003cbr\u003e \u003ci\u003eMira Harrison-Woolrych\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e24 A Description of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance as a Global Resource for Pharmacovigilance and Pharmacoepidemiology 403\u003cbr\u003e \u003ci\u003eThomas Goedecke and Peter Arlett\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e25 Overview of North American Databases 409\u003cbr\u003e \u003ci\u003eBrian L. Strom, Rita Schinnar, and Judith L. Kinman\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26 The Clinical Practice Research Datalink: The New 54 Million Fully Integrated Research Data and Clinical Trial System 421\u003cbr\u003e \u003ci\u003eJohn Parkinson\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e27 Active Surveillance: The United States Food and Drug Administration’s Sentinel Initiative 429\u003cbr\u003e \u003ci\u003eRyan M. Carnahan, Carlos J. Bell, and Richard Platt\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e28 Leveraging Routinely Collected Healthcare Data to Scale Up Drug Safety Surveillance: The EU-ADR Experience 439\u003cbr\u003e \u003ci\u003eGianluca Trifi rò and Preciosa Coloma\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e29 Development and Evaluation of Infrastructure and Analytic Methods for Systematic Drug Safety Surveillance: Lessons and Resources from the Observational Medical Outcomes Partnership 453\u003cbr\u003e \u003ci\u003ePaul Stang, Patrick Ryan, Abraham G. Hartzema, David Madigan, J. Marc Overhage,\u003c\/i\u003e \u003ci\u003eEmily Welebob, Christian G. Reich, and Thomas Scarnecchia\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eIV Pharmacovigilance and Drug\/System Organ Classes\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e30 Mechanisms of Adverse Drug Reactions 465\u003cbr\u003e \u003ci\u003eMunir Pirmohamed\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e31 Fatal Medication Errors and Adverse Drug Reactions 489\u003cbr\u003e \u003ci\u003eRobin E. Ferner and Sarah E. Mcdowell\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e32 Dermatological Adverse Drug Reactions 503\u003cbr\u003e \u003ci\u003eLaurence Valeyrie-Allanore and Jean-Claude Roujeau\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e33 Gastrointestinal Adverse Drug Reactions 513\u003cbr\u003e \u003ci\u003eAngel Lanas Arbeloa and Carlos Sostres Homedes\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e34 Hematological Adverse Drug Reactions 527\u003cbr\u003e \u003ci\u003ePeter J. Carey\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e35 Hepatic Adverse Drug Reactions 539\u003cbr\u003e \u003ci\u003eGuruprasad P. Aithal and Dominique Larrey\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e36 Ocular Side Effects of Prescription Medications 557\u003cbr\u003e \u003ci\u003eFrederick W. Fraunfelder\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e37 Renal Adverse Drug Reactions 567\u003cbr\u003e \u003ci\u003eGert A. Verpooten\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e38 The Cardiovascular Spectrum of Adverse Drug Reactions 577\u003cbr\u003e \u003ci\u003eCharles Schubert and Judith Hsia\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e39 Neurological Adverse Events 585\u003cbr\u003e \u003ci\u003eBradford B. Walters\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSpecial Populations\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e40 Drug Safety in Pregnancy 611\u003cbr\u003e \u003ci\u003eChristina D. Chambers and Elizabeth B. Andrews\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e41 Pharmacovigilance in Pediatrics 625\u003cbr\u003e \u003ci\u003eM. Dianne Murphy, Judith Cope, and Solomon Iyasu\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e42 Drugs and the Elderly 639\u003cbr\u003e \u003ci\u003eJamie J. Coleman\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eSpecial Product Classes\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e43 Anesthetic Adverse Drug Reactions 659\u003cbr\u003e \u003ci\u003eAnita Holdcroft and Karine Nouette-Gaulain\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e44 Pharmacoepidemiology as Part of Pharmacovigilance for Biologic Therapies 685\u003cbr\u003e \u003ci\u003eJohn Acquavella, Brian Bradbury, Cathy Critchlow, Jason B. Litten, J. Michael Sprafka,\u003c\/i\u003e \u003ci\u003eand John Sullivan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e45 Surveillance for Medical Devices: USA 703\u003cbr\u003e \u003ci\u003eThomas P. Gross\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e46 The Effi cacy and Safety of Selective Serotonin Reuptake Inhibitors for the Treatment of Depression in Children and Adolescents 719\u003cbr\u003e \u003ci\u003eJ. Magno Zito, D.J. Safer, and Satish Valluri\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e47 Nonsteroidal Anti-infl ammatory Drugs – Cyclooxygenase-2 Inhibitors: Risks and Benefits 735\u003cbr\u003e \u003ci\u003eK. Arnold Chan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e48 Introduction to Pharmionics: The Vagaries in Ambulatory Patients’ Adherence to Prescribed Drug Dosing Regimens, and Some of Their Clinical and Economic Consequences 751\u003cbr\u003e \u003ci\u003eJohn Urquhart and Bernard Vrijens\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e49 Design and Implementation of Surveys to Assess Patient and Healthcare Provider Understanding of Risks and Safe Use Conditions 769\u003cbr\u003e \u003ci\u003eKelly Hollis and Alicia Gilsenan\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003eVI Training and Education And Directions\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e50 Eu2P: The First European Online Public–Private Joint Training Program in Pharmacovigilance and Pharmacoepidemiology 787\u003cbr\u003e \u003ci\u003eKarine Palin, Christa Bataille, Stéphane Liège, Ralph Schimmer, and Annie Fourrier-Réglat\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e51 Teaching and Learning Pharmacovigilance 793\u003cbr\u003e \u003ci\u003eFrank May\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e52 Practical Experience in Teaching Pharmacovigilance 805\u003cbr\u003e \u003ci\u003eStephen Evans and Ian Douglas\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e53 An Historical Perspective of the Future of Pharmacovigilance 807\u003cbr\u003e \u003ci\u003eNicholas Moore\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eIndex 819\u003c\/p\u003e","brand":"Wiley-Blackwell","offers":[{"title":"Default Title","offer_id":51767549460823,"sku":"9780470671047","price":212.75,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9780470671047.jpg?v=1758713739","url":"https:\/\/bookcurl.com\/products\/manns-pharmacovigilance-9780470671047","provider":"Book Curl","version":"1.0","type":"link"}