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PROGRAM CHAIR
 Nancy Smith, PhD, Former Director, Office of Training and Communications, CDER, U.S. Food and Drug Administration
COMMITTEE
Martin Harvey-Allchurch, LLM, Head of Executive Support, European Medicines Agency, European Union
Teresa Ancukiewicz, Senior Manager, Boston Scientific Corporation, United States
Valdo Arnera, MD, General Manager, Europe PHT Corporation, Switzerland
Robert G. Baum, PhD, Executive Director, Pfizer Global R&D, United States
Danny A. Benau, PhD, Associate Professor, Biomedical Writing, University of the Sciences in Philadelphia, United States
Larry A. Blankstein, PhD, Senior Director, Clinical Research, Genzyme Corporation, United States
Mariette Boerstoel-Streefland, MD, MBA, MS, Executive Director, Pharmacovigilance/Risk Management, Forest Research Institute, Forest Laboratories, Inc., United States
Kay Bross, MEd, CEO, Interop, K.Bross Consulting, LLC, United States
Alicia Cadogan, PharmD, Director, Medical Communications, Wyeth Pharmaceuticals, United States
Joy A. Cavagnaro, PhD, RAC, President, Access BIO, United States
Neal Collins, MD, Senior Medical Director, Global Medical Oncology, Pfizer Inc., United States
Joseph J. DeGeorge, PhD, Vice President, Safety Assessment, Merck & Company, Inc., United States
Bernd Eberwein, Executive Director, BAH, Germany
Stanley A. Edlavitch, PhD, MA, Professor, Epidemiology and Director, Graduate Training, School of Medicine, University of Missouri Kansas City, United States
Brian D. Edwards, MD, MRCP, Director, Pharmacovigilance and Drug Safety, NDA Regulatory Science Ltd., United Kingdom
Shantal Feltham, President, Stiris Research Inc, United States
John Friel, JD, Deputy Director, OTCOM, CDER, FDA, United States
David Fritsche, MBA, Vice President, Global BMRA IT and BMO Systems, Biomedical Operations, Genzyme Corporation, United States
Melvyn Greberman, MD, MPH, MS, FACPM, President, Public Health Resources, LLC, United States
William W. Gregory, Senior Director, Safety and Risk Management, Pfizer Inc., United States
William R. Hahn, President, Science Branding Communications, United States
Gregory M. Hockel, PhD, MBA, Sr. Vice President, Regulatory Affairs Worldwide, PharmaNet, Inc., United States
Christopher J Holloway, PhD, Group Director, Regulatory Affairs and CSO, ERA Consulting Ltd., United Kingdom
Martin D. Hynes, PhD, Director, Six Sigma Champion, Research & Development, Eli Lilly and Company, United States
Abigail C. Jacobs, PhD, Associate Director, Pharmacology/Toxicology, ONDIO, CDER, FDA, United States
Barbara R. Kamm, MA, Medical Writing Projects Manager, Allergan Inc., United States
John F. Kamp, JD, PhD, Executive Director, Coalition for Healthcare Communication, United States
Ellen Kelso, CIP, Managing Member and CEO, Goodwyn IRB, United States
Cynthia L. Kirk, PhD, Vice President, Regulatory Affairs, KV Pharmaceuticals, United States
Agnes V. Klein, MD, Director, Centre for Evaluation of Radiopharmaceuticals & Biotherapeutics, BGTD, HPFB, Health Canada, Canada
Tatsuo Kurokawa, PhD, Professor, Chiba University, Japan
Ian Laws, PhD, Vice President, Regulatory Affairs - Europe, GlaxoSmithKline Pharmaceuticals, United Kingdom
Patricia Leuchten, President, The Avoca Group, Inc.
John A Lisman, LLM, MPharm, Attorney, NautaDutilh N.V., Netherlands
Joanne S. Malia, MS, MSc, Associate Director, Medical Research Process Management, Purdue Pharma, United States
John C Marlow, MD, Chief Medical and Compliance Officer, Advanstar Communications Inc., United States
Christopher P. Milne, DVM, JD, MPH, Associate Director, Tufts Center for the Study of Drug Development, Tufts University, United States
C. Daniel Mullins, PhD, Professor and Chair, University of Maryland School of Pharmacy, United States
Jane E Myles, MS, Associate Director, Clinical Trial Management,
Genentech, Inc., United States
Moheb M Nasr, PhD, MS, Director, Office of New Drug Quality Assessment, CDER, FDA, United States
Frances E. Nolan, MBA, Vice President, Global Quality Assurance, Medidata Solutions Worldwide, United States
Robert A. Paarlberg, MS, Director, Global Regulatory Policy and Intelligence, UCB, Inc., United States
Pradip K Paul, MS, Head, Case Medical Evaluation Group, Global Pharmacovigilance and Epidemiology, sanofi-aventis, United States
Ross D Pettit, MBA, Vice President, Clinical Operations, ARIAD Pharmaceuticals, Inc., United States
Monika M. Pietrek, MD, PhD, MSc, Germany
Wayne L. Pines, President, Regulatory Services and Healthcare, APCO Worldwide, United States
Johann Proeve, PhD, Global Head, Data Management, Bayer Schering Pharma, Germany
Thomas Quinn, President, CISSP, The Hollis Group, Inc.,
United States
Peter H. Rheinstein, JD, MD, MS, FAAFP, CEO, Severn Health Solutions, United States
Pamela A. Rose, BSN, RN, Director, Clinical Trial Information Registries R&D, TAP Pharmaceutical Products, Inc., United States
Don Rosen, Principal, Don Rosen Consulting, United States
Jerald S Schindler, DrPH, Vice President, Biostatistics and Research Decision Sciences, Merck Research Laboratories, United States
Frank D. Sistare, PhD, Executive Director, Laboratory Sciences & Investigative Toxicology Safety Assessment, Merck & Company, Inc., United States
Nancy P. Smerkanich, Vice President, Regulatory Affairs, Octagon Research Solutions, Inc., United States
Jean H. Soul-Lawton, PhD, Global Medical Writing Director, Respiratory MDC, GlaxoSmithKline R&D, United Kingdom
Raymond G Starrett, MS, Senior Director, Project Management,
Targacept, Inc., United States
Ling Su, PhD, Vice President, Clinical Research and Development, Asia Pacific, Wyeth Pharmaceutical Co., Ltd., China
John Z. Sun, PhD, MBA, PMP, Global Respiratory Development Franchise, Novartis Pharmaceuticals Corporation, United States
Lynne M. Tracey, Vice President, Global Regulatory Affairs,
P&G Pharmaceuticals, Inc., United States
Bruce M. Wagman, Vice President, Regulatory Affairs and Quality Assurance Services, Covance Inc, United States
Stephen E. Wilson, DrPH, Director, Division of Biometrics III, CDER, FDA, United States
Peiling Yang, PhD, Team Leader, Division of Biometrics I, Office of Biostatistics, CDER, FDA, United States
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