Contributors

GURUPRASAD P. AITHAL, MD, MRCP, PhD

SUSAN E. ANDRADE, ScD

ELIZABETH B. ANDREWS, MPH, PhD

PETER ARLETT, BSc, MBBS, MRCP

PRIYA BAHRI, PhD

ANDREW BATE, MA

BERNARD BEGAUD, MD

Medical Epidemiologist, Division of Drug Risk Evaluation, Office of Drug Safety, Center for Drug Evaluation and Research, US Food and Drug Administration, 5600 Fishers Lane, HFD-400, Rm 15B-32, Rock-ville, MD 20857, USA, [email protected]

Consultant Hepatobiliary Physician, Queen's Medical Centre, University Hospital, D Floor, South Block, Nottingham NG7 2UH, UK, [email protected]

Senior Research Associate, Meyers Primary Care Institute, Fallon Healthcare System, and University of Massachusetts, Worcester, MA 01605, USA, [email protected]

Vice President, RTI Health Solutions, Research Triangle Institute, 3040 Cornwallis Road, PO Box 12194, Research Triangle Park, NC 27709-2194, USA, Adjunct Associate Professor, School of Public Health and School of Pharmacy, University of North Carolina at Chapel Hill, NC, USA, [email protected]

Senior Medical Assessor and CPMP Delegate, Post-Licensing Division, Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK, [email protected]

Scientific Administrator, Sector Pharmacovigilance and Post-Authorisation Safety and Efficacy of Human Medicines, European Agency for the Evaluation of Medicinal Products (EMEA), 7 Westferry Circus, London E14, 4HB, UK, [email protected]

Programme Leader, Signal Research Methodology, Uppsala Monitoring Centre, Stora Torget 3, 753 20 Uppsala, Sweden, [email protected]

Professor of Pharmacology, Department de Pharmacologie Clinique— Unite; de Pharmaco-epidemiologie, ARME-Pharmacovigilance, Universite Victor Segalen, 33076 Bordeaux, France, [email protected]

DONNA A. BOSWELL, JD, PhD Partner, Hogan & Hartson, L.L.P., Columbia Square, 555 Thirteenth

Street, NW, Washington, DC 20004-1109, USA, [email protected]

ROBERT P. BRADY, Esq.

CHRISTINA D. CHAMBERS, MPH, PhD

PAULINE CUREL, MPS

ALBAN DAHNANI, PharmD

ROBERT L. DAVIS, MD, MPH

SARAH DAVIS, BSc (Hons), PhD

CHRISTOPHER P. DAY, FRCP, MD PhD

FRANK DESTEFANO, MD, PhD

PAULE DROUAULT-GARDRAT, LL.M, CEIPI, Avocat

J. GUY EDWARDS, MB, BCh, FRCPsych, DPM

I. RALPH EDWARDS, MB, ChB, FRCP, FRACP

STEPHEN EVANS, BA, MSc, CStat, FRCP (Ed)

Partner, Hogan & Hartson, L.L.P., Columbia Square, 555 Thirteenth Street, NW, Washington, DC 20004-1109, USA, [email protected]

Assistant Professor of Pediatrics, Department of Pediatrics, UCSD Medical Center MC8446, 200 W Arbor Drive, San Diego, CA 92103, USA, [email protected]

Assistant Professor, Department of Epidemiology, Harvard School of Public Health, Boston, MA 02215, USA, [email protected]

Vice President, Safety Services, Galt Associates, Inc., 21240 Ridgetop Circle, Ste 140, Sterling, VA 20166, USA, [email protected]

Head, Centre for Adverse Drug Reactions Monitoring, Director, Intensive Medicines Monitoring Programme, Department of Preventive and Social Medicine, University of Otago, PO Box 913, Dunedin, New Zealand, [email protected]

Team Leader, Drug Information Pharmacists, Clineanswers, Clear Centre, Smales Farm Office Park, PO Box 33-1548, Takapuna, Auckland 1332, New Zealand, [email protected]

Assistant to the Head of the Pharmacovigilance Unit, Agence Francoise de Securite Sanitaire des Produits de Sante (AFSSAPS), 143/147 Bd Anatole, France 93 285 St Denis, France, [email protected]

Associate Professor, Department of Pediatrics and Epidemiology, University of Washington, and Group Health Cooperative Center for Health Studies, Seattle, WA 98101, USA, [email protected]

Scientific Assessor, Pharmacovigilance Group, Post-Licensing Division, Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK, [email protected]

Professor of Liver Medicine and Honorary Consultant Hepatologist, Centre for Liver Research, The Medical School, Framlington Place, Newcastle upon Tyne NE2 4HH, UK, [email protected]

Project Director, Vaccine Safety Datalink, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA, [email protected]

Pharmacist, Lovells, 37 Avenue Pierre-1er-De Serbie, 75008 Paris, France, [email protected]

Visiting Professor, Khon Kaen University, Khon Kaen and Prince of Songkla University, Hat Yai, Thailand

Director, Uppsala Monitoring Centre, Stora Torget 3, 753 20 Uppsala Sweden, [email protected]

Lecturer in Epidemiology, Department of Epidemiology and Public Health, Ninewells Hospital and Medical School, Dundee DD1 9SY, UK, [email protected]

Professor of Pharmacoepidemiology, Medical Statistics Unit, The London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK, [email protected]

RICHARD E. FERNER, MD, MSc, FRCP

JONATHAN A. FINKELSTEIN, MD, MPH

F. T. FRAUNFELDER, MD

F. W. FRAUNFELDER, MD

SIR CHARLES GEORGE, BSc, MD, FRCP

MICHAEL J. GOODMAN, PhD

DAVID J. GRAHAM, MD, MPH

A. C. VAN GROOTHEEST, MD

THOMAS GROSS, MD, MPH

JERRY H. GURWITZ, MD

CHRISTOPH HILTL, Dr.jur.

NORMA KELLETT, BSc, MBChB, MRCGP, FFPM

LARRY G. KESSLER, ScD

JUDITH L. KINMAN, MA

Director, West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital, Birmingham B18 7QH, UK, [email protected]

Associate Professor, Department of Ambulatory Care and Prevention and of Pediatrics, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA 02215, USA, [email protected]

Professor of Ophthalmology, Casey Eye Institute, Oregon Health Sciences University, 3375 SW Terwilliger Blvd, Portland, OR 97035, USA, [email protected]

Assistant Professor, Cornea and External and Disease Director of the National Registry of Drug-Induced Ocular Side Effects, Casey Eye Institute, Oregon Health Sciences University, 3375 SW Terwilliger Blvd, Portland, OR 97035, USA, [email protected]

Medical Director, British Heart Foundation, 14 Fitzhardinge Street, London W1H 6DH, UK, [email protected]

Physician Scientist, Division of Research, Kaiser Foundation Research Institute, Oakland, CA 94611, USA

Senior Research Investigator, HealthPartners Research Foundation, Minneapolis, MN 55440, USA, [email protected]

Associate Director for Science and Medicine, Office of Drug Safety, Centre for Drug Evaluation and Research, US Food and Drug Administration, 5600 Fishers Lane, HFD-400, Rm 15B-32, Rockville MD 20857, USA, [email protected]

Director, Netherlands Pharmacovigilance Centre Lareb, Goudsbloem vallei 7, 5273 MH's-Hertogenbosch, The Netherlands, [email protected] lareb.nl

Director, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, US Food and Drug Administration, 1350 Piccard Drive, Room 300P, Rockville, MD 20850, USA, [email protected]

The Dr John Meyers Professor of Primary Care Medicine, University of Massachusetts Medical School and Executive Director, Meyers Primary Care Institute, Fallon Healthcare System, and University of Massachusetts Medical School, Worcester, MA 01605, USA

Partner, Lovells Boesebeck Droste, Marstallstrasse 8, 80539 Munchen, Germany, [email protected]

Director Clinical Services, Inveresk Research, Tranent EH33 2NE, UK, [email protected]

Office Director, Office of Surveillance and Biometrics, Centre for Devices and Radiological Health, US Food and Drug Administration, 1350 Piccard Drive, Rockville MD 20850, USA [email protected]

Project Manager, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, 824 Blockley Hall, 423 Guardian Drive, Philadelphia, PA 19104-6021, USA, [email protected]

STEPHEN L. KLINCEWICZ, DO, MPH, JD

CARMEN KREFT-JAIS, MD

PAOLA LA LICATA, JD

DAVID H. LAWSON, CBE, MD, FRCP

MARK D. LEARN, Esq. MARIE LINDQUIST, MSc Pharm

THOMAS M. MACDONALD, BSc, MD, FRCP, FESC

NICHOLAS MACFARLANE, BA

STUART J. MAIR, MBChB, DRCOG: DCPSA

PENELOPE K. MANASCO, MD

RONALD D. MANN, MD, FRCP, FRCGP, FFPM

UNA MARTIN, BSc, PhD, FRCPI

BRIAN C. MARTINSON, PhD RONALD MEYBOOM, MD, PhD CAROLINE MOORE, BA (Oxon) NICHOLAS MOORE, MD, PhD

cceb.med.upenn.edu, Regional Managing Editor, Pharmacoepidemiology and Drug Safety

Global Safety Officer, Drug Safety and Surveillance, Johnson and Johnson Pharmaceutical Research and Development LLC, 1125 Tren-ton-Harbourtown Road, Titusville, NJ 08560-0200, USA, [email protected] prdus.jnj.com

Head, Pharmacovigilance Unit, Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), 143/147 Bd Anatole France, 93 285 St Denis, France, [email protected]

Lawyer, Lovells, Via Dei Due Marcelli 66, 00187 Roma, Italy, [email protected]

Head of Department of Clinical Pharmacology, Royal Infirmary, Glasgow, UK, [email protected]

Associate, Hogan & Hartson, L.L.P., Columbia Square, 555 Thirteenth Street, NW, Washington, DC 20004-1109, USA, [email protected]

Head of Data Management & Research, General Manager, Uppsala Monitoring Centre, Stora Torget 3, 753 20 Uppsala, Sweden, [email protected]

Professor of Clinical Pharmacology and Pharmacoepidemiology, Director, MEdicines MOnitoring Unit (MEMO), Department of Clinical Pharmacology and Therapeutics, University of Dundee, Ninewells Hospital and Medical School, Dundee DD1 9SY, UK, [email protected]

Partner, Lovells, 65 Holborn Viaduct, London EC1A 2DY, UK, nicholas. [email protected]

Medical Advisor, Inveresk Research, Tranent EH33 2NE, UK, [email protected]

Chief Medical Officer, First Genetic Trust, 3 Parkway North Center Suite 150N, Deerfield, IL 60015, USA, [email protected]

Professor Emeritus, University of Southampton, UK, and 42 Hazleton Way, Waterlooville, Hampshire PO8 9BT, UK, [email protected] fsbusiness.co.uk

Senior Lecturer in Clinical Pharmacology, Division of Medical Sciences, The University of Birmingham, Queen Elizabeth Hospital, Edgbaston, Birmingham B15 2TH, UK, [email protected]

Research Investigator, HealthPartners Research Foundation, Minneapolis, MN 55440, USA, [email protected]

Medical Adviser, Uppsala Monitoring Centre, Stora Torget 3, 753 20 Uppsala, Sweden, [email protected]

Barrister, Lovells, 65 Holborn Viaduct, London EC1A 2DY, UK, [email protected]

Professor of Clinical Pharmacology, Departement de Pharmacologie, Universite; Victor Segalen—CHU de Bordeaux, 33076 Bordeaux cedex, France, [email protected]

MICHAEL MOSTELLER, MS, PhD

WALTER S. NIMMO, BSc, MD, FRCP, FRCA, FANZCA, FFPM, FRSE

STEN OLSSON, MSci, Pharm

ROLAND ORRE, MSc

TONI PIAZZA-HEPP, PharmD

GRAHAM A. PIPKIN, BSc (Hons)

MUNIR PIRMOHAMED, PhD, FRCP, FRCP (Ed)

RICHARD PLATT, MD, MSc

E. P. VAN PUIJENBROEK, MD, PhD

MARSHA A. RAEBEL, PharmD

GAILE RENEGAR, JD, RPh

PAOLO RICCI, JD

PATRICIA RIESER, BSN, RN, CFNP

Statistical Geneticist, Population Genetics, Genetics Research, Glaxo SmithKline, 5 Moore Drive, Research Triangle Park, NC 27709, USA, [email protected]

Chief Executive, Inveresk Research, Tranent EH33 2NE, UK, walter. [email protected]

Head, External Affairs, Uppsala Monitoring Center, Stora Torget 3, 753 20 Uppsala, Sweden, [email protected]

Department of Mathematical Statistics, Stockholm University S-10691 Stockholm, Sweden, [email protected]

Professor of Pharmacology, Department of Pharmacology and Therapeutics, The University of Liverpool, Ashton Street, Liverpool L69 3GE, UK, [email protected]

Deputy Director, Division of Surveillance, Research and Communication Support, Office of Drug Safety, Center for Drug Evaluation and Research, US Food and Drug Administration, 5600 Fishers Lane, HFD-400, Rm 15B-32, Rockville, MD 20857, USA, [email protected] cder.fda.gov

Communications Manager, GI, Neurology and GI GCS, GlaxoSmith-Kline, Stockley Park West, Uxbridge, Middlesex UB11 1BU, UK, [email protected]

Professor of Clinical Pharmacology/Consultant Physician, Department of Pharmacology and Therapeutics, The University of Liverpool, Ashton Street, Liverpool L69 3GE, UK, [email protected]

Professor of Ambulatory Care and Prevention, Harvard Medical School, Director of Research, Harvard Pilgrim Health Care, 133 Brookline Avenue, 6th Floor, Boston MA 02215, USA, [email protected] harvard.edu

Head, Science Department, Netherlands Pharmacovigilance Centre Lareb, Goudsbloemvallei 7, 5273 MH's-Hertogenbosch, The Netherlands, [email protected]

Pharmacotherapy Research Manager, Kaiser Permanente Colorado, and Adjoint Associate Professor of Pharmacy, University of Colorado School of Pharmacy, Denver, CO 80231, USA, [email protected]

Director, Post-Licensing Division, Medicines Control Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, UK, [email protected] mca.gov.uk

Director, Genetics Education and External Relations, Genetics Research, GlaxoSmithKline, 5 Moore Drive, Research Triangle Park, NC 27709, USA, [email protected]

Partner, Lovells, Via Dei Due Marcelli 66, 00187 Roma, Italy, [email protected]

Consultant, Genetics Education and External Relations, Genetics Research, GlaxoSmithKline, 5 Moore Drive, Research Triangle Park, NC 27709, USA, [email protected]

DOUGLAS ROBLIN, PhD

SUSAN RODEN, BSc, MSc, MRPS

DENNIS ROSS-DEGNAN, ScD

JOHN-CLAUDE ROUJEAU, MD

DAVID H. SMITH, RPh, PhD

STEPHEN B. SOUMERAI, ScD

PAUL E. STANG, PhD

ROSIE STATHER, MA (Cantab)

DOUGLAS STEINKE, BSc (Pharm), MSc, PhD

PETER D. STONIER, PhD, MRCPsych, FRCP, FFPM

BRIAN STROM, MD, MPH

MIRIAM C.J.M. STURKENBOOM PHD, MSc, PharmD

Research Scientist, Kaiser Permanente Georgia, Atlanta, GA 30305, USA, [email protected]

Director, Global Pharmacovigilance and Risk Management, GCSP, GlaxoSmithKline Research and Development Ltd, Greenford Road, Greenford, Middlesex UB6 OHE, UK, [email protected]

Associate Professor, Department of Ambulatory Care and Prevention, Harvard Medical School, and Harvard Pilgrim Health Care, Boston, MA 02215, USA, [email protected]

Assistant, Service de Dermatologie, Hopital Henri Mondor, Universite; Paris XII, 94010 Creteil, France, [email protected]

Senior Medical Officer, Medicines Control Agency, Market Towers, 1 Nine Elms Lane, Vauxhall, London SW8 5NQ, UK, [email protected] lineone.net

Director, Drug Safety Research Unit, Bursledon Hall, Blundell Lane, Southampton SO31 1AA, UK, [email protected]

Investigator, Kaiser Permanente Center for Health Research, Portland, OR 97227, USA, [email protected]

Professor of Ambulatory Care and Prevention, Department of Ambulatory Care and Prevention, Harvard Medical School and Director of Drug Policy Research Group, Harvard Pilgrim Health Care, Boston, MA 02215, USA, [email protected]

Executive Vice-President, Galt Associates, Inc., 1744 DeKalb Pike, Suite 175, Blue Bell, PA 19422-3352, USA, Adjunct Associate Professor of Epidemiology, University of North Carolina School of Public Health, Chapel Hill, NC, USA, [email protected]

Editor, Drug Safety; Consulting Editor, Reactions Weekly, Adis International Ltd, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland 10, New Zealand, [email protected]

Research Pharmacist, Primary Care Information Group, Information and Statistics Division, Room BO12, Trinity Park House, South Trinity Road, Edinburgh EH5 3SQ, UK, [email protected]

Medical Director, HPRU Medical Research Centre, University of Surrey, Egerton Road, Guildford GU2 5XP, UK, [email protected]

Director, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, 824 Blockley Hall, 423 Guardian Drive, Philadelphia PA 19104-6021, USA, [email protected]

Assistant Professor, Pharmaco-epidemiology Unit, Department of Epidemiology and Biostatistics and Medical Informatics. Erasmus University Medical Centre., PO Box 1738, 3000 DR Rotterdam, The Netherlands; International Pharmacoepidemiology and Pharmaco-economics Research Centre (IPPRC), Via Mantova 11, 20033 Desio (MI), Italy, [email protected]

PATRICIA TENNIS, PhD

MARGARET THOROGOOD, PhD

GABRIELLE TURNER, LL.M

MARIANNE ULCICKAS-YOOD, DSc, MPH

LAURENCE VALEYRIE, MD

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