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,...