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Program Committee

  • Michelle L. Charles, MPH
    Michelle L. Charles, MPH Director, Regulatory Affairs, Gene Therapy Program and Orphan Disease Center
    University of Pennsylvania, Perelman School of Medicine, United States
  • Virginia  Hussong
    Virginia Hussong Chief, Data Standards Program, 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 Senior Vice President, Life Sciences
    Orion Business Innovation, 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 Director, Consulting Expert
    CGI Technologies, United States
  • Cindy  Chiu
    Cindy Chiu Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Jake  Doran
    Jake Doran Chief Technology Officer
    Genpact, 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 Informatics Advisor, OD, CBER
    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 Senior Director, Regulatory Operations
    Lexicon Pharmaceuticals, United States
  • Daniel F. Orfe, MS
    Daniel F. Orfe, MS President and CEO
    Regulatory eSubmissions, LLC, United States
  • Vada A. Perkins, DrSc, MS, MSc
    Vada A. Perkins, DrSc, MS, MSc Global Regulatory Policy and Intelligence
    Bayer Pharmaceuticals, United States
  • Michiel  Stam
    Michiel Stam Regulatory Information Scientist
    Qdossier B.V., Netherlands
  • Stacy  Tegan
    Stacy Tegan Senior Program Manager
    Transcelerate Biopharma Inc., United States
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