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Program Committee

  • Michiel  Stam
    Michiel Stam Director Regulatory Information Management
    Qdossier - A Celegence Company, Netherlands
  • Karen  McCarthy Schau
    Karen McCarthy Schau Director, Risk-based Study Management
    Vertex Pharmaceuticals, United States
  • Stacy  Tegan
    Stacy Tegan Program Director
    Transcelerate Biopharma Inc., United States
  • Ethan  Chen, MBA, MS, PMP
    Ethan Chen, MBA, MS, PMP Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
    FDA, United States
  • Jake  Doran
    Jake Doran Head of Digital
    MAPS Public Benefit Corporation (MAPS PBC), United States
  • Jo  English
    Jo English Vice President, Regulatory Information Management
    Calyx, United Kingdom
  • Vahe  Ghahraman, PhD
    Vahe Ghahraman, PhD Senior Director, Global Regulatory Operations Head
    Apellis Pharmaceuticals, Inc. , United States
  • Kristen  Sauter, MBA
    Kristen Sauter, MBA Director, Global Regulatory Informatics & Analytics
    Takeda Pharmaceuticals, United States
  • Cary  Smithson, MBA
    Cary Smithson, MBA Senior Director, Regulatory Business Transformation & Systems Management
    Pharmalex, United States
  • Katherine  Novak, MS
    Katherine Novak, MS Senior Advisory Consultant, Life Sciences
    NNIT, United States
  • Alison  Buno, MBA
    Alison Buno, MBA Sr. Director, Regulatory Submissions
    Abbvie, Inc., United States
  • Joanne  Malia, MS, MSc
    Joanne Malia, MS, MSc Director, Development Records Management
    Regeneron Pharmaceuticals, United States
  • Jamie  O'Keefe
    Jamie O'Keefe Head, Clinical and Regulatory Consulting Services
    Astrix Technology, Inc, United States
  • Joel  Finkle
    Joel Finkle Industry Expert
    Retired, United States
  • Sandra  Krogulski, MA
    Sandra Krogulski, MA Director, GRSO Innovation and Business Operations Lead
    Bristol-Myers Squibb Company, United States
  • Rob  Labriola, MS
    Rob Labriola, MS Exec. Director, Regulatory Operations
    Garuda Therapeutics, United States
  • Daniel  Offringa
    Daniel Offringa Principal Consultant
    eSub Solutions, United States
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
    FDA, United States
  • Representative Invited
    Representative Invited DIA, United States
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