メニュー
プログラム委員会
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Jonathan Andrus, MS
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Past Chair/Current Treasurer
Society For Clinical Data Management, United States -
Matt Baldwin, MS
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Biomedical Data Stewardship Senior Manager
Amgen, United States -
Amy Bertha
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Executive Director, Regulatory Policy and Innovation
Bayer, United States -
Poonam Bordoloi, PharmD
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Executive Director, Head of Global Medical Affairs Capabilities
Organon & Co., United States -
David Bowers, PharmD
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Senior Director, Operations
PPD, United States -
Philip (P.J.) Brooks, PhD
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Deputy Director, Division of Rare Diseases Research Innovation
National Center for Advancing Translational Sciences (NCATS), NIH, United States -
Jennifer Burgess, MBA, MPH
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Vice President, Global Engagement and Communications
TransCelerate Biopharma Inc., United States -
Bill Byrom, PhD
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Vice President, Product Intelligence and Positioning; Principal, eCOA Science
Signant Health , United Kingdom -
Susan Callery-D'Amico, BSN
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Retired, Vice President, R&D Quality Assurance, AbbVie
United States -
Meghana Chalasani, MHA
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Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER
FDA, United States -
Yeh-Fong Chen, PhD
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Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER
United States -
Karla Childers, MS
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Head, Bioethics-Based Science and Technology Policy
Johnson & Johnson, United States -
Deborah Collyar
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President
Patient Advocates In Research (PAIR), United States -
Freda Cooner, PhD
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Senior Director - Statistics
Eli Lilly and Company, United States -
Stephanie Y. Crawford, PhD, MPH, MS
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Professor, Pharmacy Systems, Outcomes and Policy
University of Illinois at Chicago, United States -
Sonya Eremenco, MA
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Executive Director, PRO Consortium
Critical Path Institute, United States -
Ron Fitzmartin, PhD, MBA
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Senior Advisor, Office of Regulatory Operations, CBER
FDA, United States -
David Fryrear, MS
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Executive Vice President and Head of Quality Assurance
Astellas, United States -
M. Scott Furness, PhD
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Deputy Director, Office of New Drug Products, OPQ, CDER
FDA, United States -
William Gregory, PhD
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Senior Director, Safety and Risk Management
Pfizer Inc, United States -
Marianne Hamilton Lopez, PhD, MPA
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Research Director, Value-Based Payment Reform
Duke-Margolis Center For Health Policy, United States -
Sabine Haubenreisser, PhD, MSc
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Principal Scientific Administrator, Stakeholders and Communication Division
European Medicines Agency, Netherlands -
Jeremy Jokinen, PhD, MS
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Vice President and Head, Safety Evidence and Sciences
Bristol-Myers Squibb Company, United States -
Nadina Jose, MD
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Assistant Professor, School of Health Professions, MS Clinical Research Program
Rutgers, The State University of New Jersey, United States -
Sean D. Kennedy, MPH
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Global Head, Real World Evidence
ICON plc, United States -
Agnes Klein, MD
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Senior Medical Advisor
Health Canada, Canada -
Darryl L'Heureux, PhD, MPharm, MSc
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Director, Clinical Science, Medical Writing, and Publications
Ambrx, Inc, United States -
Erik Laughner
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Project Manager, Business Operations Staff, OD, CBER
FDA, United States -
Rebecca Lipsitz, PhD
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Senior Director, TA Regulatory Intelligence and Portfolio Policy, Late R&I RA
AstraZeneca, United States -
Christopher Marrone, PharmD, RPh
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Outcomes Liaison Advisor – National Accounts, Value, Evidence and Outcomes (VEO)
Eli Lilly and Company, United States -
Chris Matheus, MBA
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Chief Commercial and Networking Officer
Global Life Sciences Alliance (GLSA), United States -
K. Kimberly McCleary
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Founder and Chief Executive Officer
The Kith Collective, LLC, United States -
Ann Meeker-O'Connell, MS
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Director, Office of Clinical Policy, Office of Clinical Policy and Programs, OC
FDA, United States -
Christine Moore, PhD
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Executive Director, Global External Advocacy and Standards
Organon & Co., United States -
Jean M. Mulinde, MD
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Associate Director, Division of Clinical Compliance Evaluation, OSI
FDA, United States -
Nobumasa Nakashima
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Health Policy Director, National Healthcare Policy Secretariat
Cabinet Office, Japan -
Michael Neidl, MBA, MS, MSc
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Senior Consultant
Clinical Research Quality Consultant, United States -
Anita Nelsen
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Executive Vice President, Translational Medicine
Parexel, United States -
David O Olaleye, PhD, MSc
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Senior Manager and Principal Research Statistician
SAS Institute Inc., United States -
David J Pepperl, PhD
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Senior Consultant and Nonclinical Group Leader
Biologics Consulting, United States -
Sissi Pham, PharmD
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Chief Executive Officer
AESARA, United States -
Paul Phillips
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Director, Office of Program Operations, OND, CDER
FDA, United States -
James E. Polli, PhD
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Prof, Ralph F Shangraw/Noxell Endowed Chair in Industrial Pharmacy/Pharmaceutic
University of Maryland School of Pharmacy, United States -
Margaret Richards, PhD, MPH
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Executive Director, Solutions
Panalgo, United States -
Steven L. Roberds, PhD
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Chief Scientific Officer
Tuberous Sclerosis Alliance, United States -
Khyati Roberts, RPh
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Retired
Retired, United States -
Khushboo Sharma, MBA
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Chief Regulatory Innovation Officer
Accumulus Synergy, United States -
Nancy Slater, MBA, PMP
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Senior Director, Portfolio Program Management Therapeutic Area Head
AbbVie, Inc., United States -
Nancy Pire Smerkanich, DrSc, MS
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Assistant Professor Regulatory & Quality Sciences
University of Southern California School of Pharmacy, United States -
Meredith Smith, PhD, MPA, FISPE
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Senior Director, Implementation Science Pillar Lead
Evidera, Inc, United States -
Elizabeth Somers, MS
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Executive Director, Global Project and Alliance Management
Merck Sharp & Dohme LLC, United States -
Evelyn Soo, PhD, MS
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Director, Bureau of Gastroenterology, Infection and Viral Diseases, HPFB
Health Canada, Canada -
Jeffrey N. Stuart, PhD
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Associate Vice President, Global Regulatory Affairs
Merck Sharp & Dohme LLC , United States -
Ling Su, PhD
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Research Fellow
Shenyang Pharmaceutical University, Yeehong Business School, China -
Rachel Turow, JD, MPH
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Managing Counsel, FDA Regulatory
Walmart, Inc., United States -
Kristin Voorhees, MA
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Director, Patient Advocacy
Ultragenyx, United States -
Nancy Watanabe, MS, PMP
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Independent Consultant
Independent Consultant, United States -
Judith Zander, MD
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Director, Office of Pharmacovigilance and Epidemiology, OSE, CDER
FDA , United States