Mann's Pharmacovigilance (eBook)

Elizabeth B. Andrews, Nicholas Moore (Herausgeber)

eBook Download: EPUB

2014 | 3. Auflage
John Wiley & Sons (Verlag)
978-1-118-82014-8 (ISBN)

Infos

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 databases and pharmacoepidemiological methodologies to proactively monitor for and assess safety signals. It includes chapters on drug safety practice in specific organ classes, special populations and special products, and new developments in the field.
From an international team of expert editors and contributors, Mann’s Pharmacovigilance is a reference for everyone working within pharmaceutical companies, contract research organisations and medicine regulatory agencies, and for all researchers and students of pharmaceutical medicine.
The book has been renamed in honor of Professor Ronald Mann, whose vision and leadership brought the first two editions into being, and who dedicated his long career to improving the safety and safe use of medicines.

Elizabeth B Andrews PhD, MPH, FISPE, Vice President, Pharmacoepidemiology and Risk Management,
RTI Health Solutions, Research Triangle Park, NC, USA
Nicholas Moore MD, PhD, FRCP(Edin), FISPE, Professor of Clinical Pharmacology, Service Hospitalo-Universitaire de Pharmacologie, Bordeaux, France

Rezensionen

"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." (Doody's, 9 January 2015)

Highly Commended at the BMA Medical Book Awards 2015

Textauszug

Contributors

ELIZABETH B. ANDREWS, PhD, MPH, FISPE

RTI Health Solutions, Research Triangle Institute, Research Triangle Park, NC, USA; School of Public Health and School of Pharmacy, University of North Carolina at Chapel Hill, NC, USA

JOHN ACQUAVELLA, PhD

Executive Director, Center for Observational Research, Amgen, Inc., Thousand Oaks, CA, USA

GURUPRASAD P. AITHAL, MBBS, MD, FRCP, PhD

Co-Director, National Institute for Health Research: Nottingham Digestive Diseases Biomedical Research Unit, Nottingham University Hospitals NHS Trust, Nottingham, UK; University of Nottingham, Queen's Medical Centre, Nottingham, UK

LUIS ALESSO, MD

Specialist in Pharmaceutical Medicine Professor in School of Medicine, National University of Córdoba, Argentina; Head of Pharmacovigilance Department, School of Public Health, National University of Córdoba, Argentina.

Haggar H. Ampadu, BSc, MS

Director of Operations, WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, University of Ghana Medical School, Accra, Ghana

PETER ARLETT, BSc(Hons), MBBS, MRCP, FFPM

Head of Pharmacovigilance Department, Inspections & Human Medicines Pharmacovigilance Division, European Medicines Agency, London, UK

JEFFREY K. ARONSON, MA DPhil FRCP FBPharmacolS FFPM(Hon)

President Emeritus, British Pharmacological Society; Reader in Clinical Pharmacology, Nuffield Department of Primary Care Health Sciences, University of Oxford; Consultant Physician, Oxford University Hospitals NHS Trust, Oxford, UK

PRIYA BAHRI, PhD

Pharmacovigilance Lead for Guidelines and Risk Communication, European Medicines Agency, London, UK

Paul Barrow, MD MSc FRCP, PhD

Vigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, London, UK

CHRISTA BATAILLE, LL.M.

Eu2P Legal Manager, Eu2P Central Office, Université de Bordeaux, Bordeaux, France

ANDREW BATE, PhD

Senior Director, Worldwide Safety & Regulatory Epidemiology, Pfizer Ltd, UK; Department of Computing and Mathematics, Brunel University, London, UK; New York University School of Medicine, New York, NY, USA

BERNARD BÉGAUD, MD, PhD

Department of Pharmacology, Université Bordeaux Segalen, Bordeaux, France

CARLOS J. BELL, MPH

Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Commander, US Public Health Service, Silver Spring, MD, USA

RICARDO BENÍTEZ-VÁZQUEZ, MD, CCRP

Clinical Trials Manager, Center of Pharmacological and Biotechnology Research. CIFBIOTEC, Mexico City, Mexico

JESSE A. BERLIN, ScD

Vice President and Head of Global Epidemiology, Johnson & Johnson, New Brunswick, NJ, USA

PIPASHA BISWAS, MD MFPM DM MRQA

Principal Consultant, Director & QPPV, Symogen Limited, London, UK

STELLA C.F. BLACKBURN, MB MS MA MSc FRCP(Ed) FISPE FFPM Dip Pharm Med LSHTM

EMA Risk Management Development and Scientific Lead, European Medicines Agency, London, UK

ALTHEA BONGAT, RPh

Pharmacist and Masteral Candidate in Pharmacology, University of the Philippines, Manila, Philippines

BRIAN BRADBURY, DSc

Director, Center for Observational Research, Amgen, Inc., Thousand Oaks, CA, USA

M. MILES BRAUN, MD MPH

Consultant, North Potomac, MD, USA

ELLIOT BROWN, MB, ChB, BMedSci, MRCGP, MFPM, FRCP(E)

Managing Director, Elliot Brown Consulting Ltd, Leeds, UK

PETER J. CAREY, FRCP, FRCPEd, FRCPath

Consultant Haematologist, Royal Victoria Infirmary, Newcastle upon Tyne, UK.

RYAN M. CARNAHAN, PharmD, MS

Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, USA

JACQUES CARON, MD

Professor of Pharmacology, Centre Regional de pharmacovigilance, University Hospital, Lille, France

CHRISTINA D. CHAMBERS, PhD, MPH

Professor, Co-Director, Center for Promotion of Maternal Health and Infant Development, Department of Pediatrics and Family and Preventive Medicine, University of California San Diego, La Jolla, CA, USA

K. ARNOLD CHAN, MD, ScD, FISPE

National Taiwan University Hospital, Taipei, Taiwan

THOMAS Y.K. CHAN, MBChB, MD, PhD, FRCP, FHKCP, FHKAM (Medicine)

Professor and Director, Centre for Food and Drug Safety, Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, China

MIN-CHU CHEN, MS, RPh

Acting Director, Deputy Director, Division of Pharmacovigilance I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA

JAMIE J COLEMAN, MD, MA, MRCP(UK)

Senior Clinical Lecturer in Clinical Pharmacology & Medical Education, School of Clinical and Experimental Medicine, College of Medical and Dental Sciences, University of Birmingham; Honorary Consultant Physician, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK

PRECIOSA COLOMA, MD, PhD

Assistant Professor, Department of Medical Informatics, Erasmus University Medical Center, Rotterdam, Netherlands

RAQUEL HERRERA COMOGLIO, MD, MSc, PharmD

Head of Pharmacovigilance Service, Hospital Nacional de Clínicas, School of Medicine, National University of Córdoba, Argentina

JUDITH COPE, MD, MPH

Director of Safety, Office Pediatric therapeutics, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD, USA

CATHY CRITCHLOW, PhD

Executive Director & Head, Center for Observational Research, Amgen, Inc., Thousand Oaks, CA, USA

BRENDA CROWE, PhD

Research Advisor, Global Statistical Sciences, Eli Lilly and Company, Indianapolis, IN, USA

CÉSAR DE LA FUENTE, BPharm

Head of Unit, Pharmacoepidemiology, Division of Pharmacoepidemiology and Pharmacovigilance, Agencia Espanola de Medicamentos y Productos Sanitarios, Madrid, Spain

IAN DOUGLAS, BSc MSc PhD

Lecturer, London School of Hygiene and Tropical Medicine, London, UK

Alexander N.O. Dodoo, BPharm, MSc, PhD, FPSGH, FPCPharm, MRPharmS

Associate Professor and Director, WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, University of Ghana Medical School, Accra, Ghana

BRIAN EDWARDS, BSc MD MRCP

Principal Consultant, NDA Regulatory Science Ltd, Leatherhead, UK

STEPHEN EVANS, BA, MSc, FFRCP(Edin), Hon FRCP

Professor of Pharmacoepidemiology, London School of Hygiene and Tropical Medicine, London, UK

TOMMY ERIKSSON, PhD

Professor, Lund University, Faculty of Medicine, Institution for Laborative Medicine, Lund, Sweden

PADDY FARRINGTON, PhD

Professor of Statistics, Department of Mathematics and Statistics, Faculty of Mathematics, Computing and Technology, The Open University, Milton Keynes, UK

ROBIN E. FERNER, BSc, MSc, MB BS, MD, FRCP

Honorary Professor of Clinical Pharmacology, West Midlands Centre for Adverse Drug Reactions, City Hospital; School of Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK

FERNANDA FERRAZIN, PharmD

Agenzia Italiana del Farmaco – AIFA, Rome, Italy

ANNIE FOURRIER-RÉGLAT, PharmD

Associate Professor, Service de Pharmacologie, Université de Bordeaux, Bordeaux, France

Mick Foy, MD MSc FRCP, PhD

Vigilance and Risk Management of Medicines, Medicines and Healthcare Products Regulatory Agency, London, UK

FREDERICK W. FRAUNFELDER, MD, MBA

Director Corneal/ External Eye Disease and Refractive Surgery, Professor of Ophthalmology, Martha and Eddie Petersen Endowed Professor of Ophthalmology, Casey Eye Institute, Oregon Health and Science University, Portland, OR, USA

SHELLEY GANDHI, BSc, MSc

Director – Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd, Leatherhead, UK

SOPHIE GAUTIER, PharmD, PhD

Associate Professor, Centre Regional de pharmacovigilance, University Hospital, Lille, France

ALICIA GILSENAN, PhD

Senior Director, Epidemiology, RTI Health Solutions, Durham, NC, USA

THOMAS GOEDECKE, PharmD, PhD

Regulatory Affairs & Best Evidence Department, Human Medicines Research & Development Support Division, European Medicines Agency,...

Produkt-Details

• Erscheint lt. Verlag: 24.3.2014
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Gesundheitsfachberufe
• Themenwelt: Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
• Themenwelt: Medizin / Pharmazie ► Pflege
• Themenwelt: Medizin / Pharmazie ► Pharmazie ► PTA / PKA
• Themenwelt: Technik
• Schlagworte: adverse • Clinical Pharmacology & Therapeutics • definitive • detection • Drug • Edition • Effects • important • Increasingly • Klinische Pharmakologie u. Therapie • manns • Medical Science • Medical Statistics & Epidemiology • Medicine • Medicines • Medizin • Medizinische Statistik u. Epidemiologie • patients • Pharmaceutical • Pharmacology & Pharmaceutical Medicine • pharmacovigilance • Pharmakologie • Pharmakologie u. Pharmazeutische Medizin • Practice • prevention • Reference • Safety • Science • Third
• ISBN-10: 1-118-82014-2 / 1118820142
• ISBN-13: 978-1-118-82014-8 / 9781118820148