Ruhi Ahmed, PhD, RAC, Associate Director, Regulatory Affairs, BioMarin Pharmaceutical Inc.
Susan Aiello, DVM, Principal, WordsWorld Consulting
Susan Alpert, MD, PhD, Senior Vice President, Chief Quality and Regulatory Officer, Medtronic Inc.
Patricia R. Anderson, RAC, Vice President, Regulatory Services, CanReg Inc.
Deborah M. Autor, JD, Director, Office of Compliance, CDER, US Food and Drug Administration
Paul C. Brooks, Vice President and Country Manager, BSI PS Healthcare
Melanie Bruno, MBA, PhD, Vice President, Global Regulatory Affairs and Quality, Kendle International Inc.
Alina Caraballo, Manager, Cordis Corporation Martha J. Carter, RAC, Senior Vice President,
Regulatory Affairs and Quality Assurance, Proteon Therapeutics
David E. Chadwick, PhD, RAC, Regulatory Scientist, Cook Inc.
Kamali Chance, MPH, PhD, RAC, Director, Global Regulatory Strategy, Global Regulatory Affairs, Quintiles Inc.
Mark Chang, PhD, Director, Biostatistics, Millennium Pharmaceuticals Inc.
Karen Chu, PharmD, Executive Director, International Clinical Operations, Parexel Apex International
Julia C. Cooper, PhD, Senior Director, Worldwide Head of Medical Writing Services, Parexel International Ltd.
Mason W. Diamond, DDS, Vice President, Regulatory Affairs, Isolagen Inc.
Maria E. Donawa, MD, President, Donawa Consulting SRL
Diane E. Dorman, Vice President, Public Policy, National Organization for Rare Disorders (NORD)
Jethro Ekuta, DVM, PhD, Group Director, Aggregate Safety Reporting, Bristol-Myers Squibb Co.
Gideon Elkayam, Treasurer, EAAR; CEO, Obelis SA Edward T. Furlong, PhD, Research Chemist, Methods Research and Development Program, National Water Quality Laboratory, US Geological Survey
Anita Fenty, MS, RAC, Manager, Regulatory Policy, Covance
Kate Giovino, Director, Clinical Operations, Organogenesis Inc.
William F. Greenrose, MBA, President and CEO, Qserve America Inc.
Laila Gurney, RAC, Director, Regulatory Affairs, GE HealthCare
Courtney C. Harper, PhD, Scientific Reviewer, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH, US Food and Drug Administration
Elisa D. Harvey, DVM, PhD, Senior Regulatory Consultant, CardioMed Device Consultants LLC
Sheila M. Hemeon-Heyer, JD, MS, RAC, Vice President, Global Regulatory Affairs, Boston Scientific Corporation
Nigel A.S. Hernandez, MSc, LPD, Chief Regulatory Affairs Officer, Global Regulatory Affairs, GMPRegulatory Partners
Alan Jette, PhD, Director, Boston University Health and Disability Research Institute, School of Public Health, Boston University
Corporation (SAIC)
Joseph Knight-McKenna, MBA, RAC, Senior Director, Quality and Regulatory Compliance, Drug Safety Alliance
Mark D. Kramer, MA, MS, Vice President, Regulatory Affairs, GE HealthCare
Paul Kuiken, General Manager, Pharmalink Consulting Inc.
Zvi Ladin, PhD, Advisor, Boston MedTech Advisors
Maha Lakkis, PhD, RAC, Senior Manager and Liaison, Global Regulatory Affairs, Schering-Plough
Nicole Landreville, Eng., RAC, Leader, Regulatory Affairs, GE HealthCare
Jaap L. Laufer, MD, PharmD, Managing Director, EMDAR BV
Geoffrey Levitt, JD, Vice President and Chief Regulatory Counsel, Wyeth Pharmaceuticals
Susanne M. Ludgate, MB, ChB, DMRT, FRCR, FRACR, Clinical Director, Devices, Medicines and Healthcare Products Regulatory Agency (MHRA)
Meredith Manning, JD, Attorney, Hogan & Hartson LLP
Tammy Massie, PhD, Mathematical Statistician, Office of Epidemiology and Statistics, CBER, US Food and Drug Administration
Louis J. Mazzarese, Regulatory Affairs Consultant and Executive Coach
Brian R. McCormick, JD, Attorney, Hogan & Hartson LLP
Munish Mehra, PhD, Managing Director, Global Drug Development Experts
Mark N. Melkerson, Director, Division of General, Restorative and Neurological Devices, Office
of Device Evaluation, CDRH, US Food and Drug Administration
Elaine Messa, RAC, Vice President, Medical Device Quality Systems, Quintiles Consulting
Fran Miller, JD, Professor of Law, School of Law, Boston University
Gillian A. Miller, PhD, RAC, Consultant, SciLucent LLC
Päivi Miskala, PhD, Study Endpoints Reviewer, SEALD, Office of New Drugs, CDER, US Food and Drug Administration
Ludger Moeller, Vice-Chairman, EAAR; President, Medical Device Safety Service GmbH
Joel Morganroth, MD, Chief Scientist, eResearch Technology Inc.
Rica Morris, RAC, International Regulatory Affairs, Medical Division, 3M Health Care
Susumu Nozawa, RAC, Corporate Regulatory Affairs, Becton-Dickinson and Company
Suzanne O’Shea, LLM, JD, Counsel, Baker & Daniels LLP
Akio Onishi, MBA, Vice President, Government & Industry Affairs, Medtronic Japan Co, Ltd.
Jennifer Paine, MA, MS, Worldwide Director of Regulatory Affairs, Ethicon Inc.
Toni Piazza-Hepp, PharmD, Deputy Director, Office of Surveillance and Epidemiology, Division of Surveillance and Communication Support, CDER, US Food and Drug Administration
Randy J. Prebula, Regulatory Affairs Specialist, Hogan & Hartson LLP
Paul W. Radensky, JD, MD, Partner, McDermott Will & Emery
Mika Reinikainen, LLM, MBA, Chairman, EAAR;Managing Director, AbNovo Ltd.
Stephen P. Rhodes, Director, IDE and HDE Programs, Office of Drug Evaluation, CDER, US Food and Drug Administration
Randel E. Richner, MPH, President and Founder, Neocure Group LLC
Michael Rinck, PhD, MT Promedt Consulting GmbH
Peter G. Robins, MSc, PhD, Regulatory Advisor, US Regulatory Affairs, Eli Lilly and Company
Rosina Robinson, MA, MS, RAC, Principal Consultant, Regulatory Services, Medical Device Consultants Inc.
Nathalie Ross, MA, MS, PhD, Regulatory Affairs Manager, Healthcare Products Group, CanReg Inc.
Roland G. Rotter, PhD, Director, Medical Devices Bureau, Health Canada/Santé Canada
Peter N. Ruys, PhD, Senior Consultant, R&B Consultants
Marcela Saad, MSc, President and Senior Consultant, MarcM Consulting Canada
Diana K. Salditt, Senior Regulatory Affairs Manager, Medtronic Inc.
Scott Sardeson, RAC, International Regulatory Affairs Manager, 3M Health Care, Medical Division
Jeff Schakenraad, MSc, PhD, Western Regional Manager, KEMA
David J. Schifkovitz, Director, Regulatory Affairs, GlaxoSmithKline Consumer Healthcare
Daniel G. Schultz, PhD, Director, CDRH, US Food and Drug Administration
Michael S. Sharp, PhD, FASLM, Senior Vice President, Regulatory and Clinical, ConforMIS Inc
Beth Silverstein, RAC, Director, SciLucent LLC
Mary Speagle, Executive Director, Canadian Regulatory Affairs, CanReg Inc.
Susan B. Stewart, RAC, Senior Vice President, Regulatory Affairs, Transmolecular Inc.
Dirk Stynen, PhD, President, Qarad
Nanda K. Subbarao, PhD, Senior Consultant, Biologics Consulting Group Inc.
O. Reed Tarwater, PhD, RAC, Director, Pharmaceutical Consulting Services, The Anson Group LLC
Elaine B. Taylor, Senior Medical Writer, Procter & Gamble Pharmaceuticals Inc.
Fabio Thiers, MSc, MD, PhD, Sloan School of Management, MIT Center for Biomedical Innovation
Bradley M. Thompson, MBA, JD, RAC, Shareholder, Epstein Becker & Green PC
Jeremy Tinkler, Director of Regulatory Affairs, MedPass International
René van de Zande, President and CEO, Emergo Group Inc.
Thomas R. Varricchione, Vice President, Clinical and Regulatory Affairs, WaveRx Inc.
Leigh M. Vaughan, PharmD, MBA, RAC, Head, Medical Writing, Talecris Biotherapeutics Inc.
John L. Webster, RAC, Secretary, EAAR; Managing Director, Medical Device Consultants Inc.
Martha A. Wells, MPH, RAC, Chief, Human Tissue and Reproduction Branch, CBER, US Food and Drug Administration
Chang-Hong Whitney, President, Whitney Consulting Ltd
John F. Worzalla, RAC, Regulatory Consultant, The Anson Group LLC
Elisabethann Wright, JD, Attorney, Hogan & Hartson LLP
Hiroshi Yaginuma, Specialist for New Materials, Ministry of Health, Labour and Welfare (MHLW)
Robert A. Yetter, PhD, Associate Director for Review Management, CBER, US Food and Drug
Administration
Robert E. Yocher, MHSc, RAC, Vice President, Regulatory Affairs and Corporate Quality Compliance, Genzyme Corporation
Robert Zielinski, RAC, Regulatory Affairs Manager, GlaxoSmithKline Consumer Healthcare
Bridgette Zirger, Director of Bureau of Policy, Science and International Programs, Therapeutic Products Directorate, Health Canada/Sante Canada