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Program Committee

  • Michelle L. Charles, MPH
    Michelle L. Charles, MPH Director, Regulatory Affairs, Gene Therapy Program & Orphan Disease Center
    University of Pennsylvania, Perelman School of Medicine, United States
  • Virginia  Hussong
    Virginia Hussong Data Standards Program Manager, OD, BSS, CBER
    FDA, United States
  • Sarah  Powell, RAC
    Sarah Powell, RAC President
    Powell Regulatory Services, United States
  • Jamie Marie Toth, MS
    Jamie Marie Toth, MS Director/Head of TMF Operations
    Daiichi Sankyo, Inc., United States
  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA President and CEO
    Cabeus, Inc., United States
  • Christian A. Buckley, MBA, RAC
    Christian A. Buckley, MBA, RAC Associate Director, Regulatory Affairs
    Astellas, United States
  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Owner
    Cyan Life Sciences, United States
  • Cindy  Chiu
    Cindy Chiu Director, Regulatory Affairs Operations & Quality Management
    Merck & Co., Inc., United States
  • Jake  Doran
    Jake Doran Founder, Managing Director
    List Innovations, LLC, United States
  • Betsy  Fallen, RN
    Betsy Fallen, RN Consultant
    BAFallen Consulting LLC, United States
  • Ron D. Fitzmartin, PhD, MBA
    Ron D. Fitzmartin, PhD, MBA Senior Advisor, Office of Strategic Programs, CDER
    FDA, United States
  • Mark A. Gray
    Mark A. Gray Senior Project Manager, BSS, CBER
    FDA, United States
  • Dominique  Lagrave, PharmD
    Dominique Lagrave, PharmD Director, Global Regulatory Affairs and Safety Operations
    Amgen, United States
  • Thomas J. Noto
    Thomas J. Noto Sr. Director, Regulatory Operations
    United States
  • Daniel F. Orfe, MS
    Daniel F. Orfe, MS President & CEO
    Regulatory eSubmissions, LLC, United States
  • Vada A. Perkins, BSN, MS, MSc, RN
    Vada A. Perkins, BSN, MS, MSc, RN Founder and Managing Principal
    Identifica, United States
  • Michiel  Stam
    Michiel Stam Regulatory Information Scientist
    eCTDconsultancy B.V., Netherlands
  • Stacy J. Tegan
    Stacy J. Tegan Manager, Regulatory Technology Consulting
    Accenture Accelerated R&D Services, United States
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