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Program Committee

  • Brooke  Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC Associate Vice President, US Life Sciences Advisory and Consulting
    NNIT, Inc., United States
  • Cindy  Chiu
    Cindy Chiu Senior Director, Regulatory Affairs Operations and Quality Management
    Merck & Co., Inc., United States
  • Peter  Terbeek, MBA
    Peter Terbeek, MBA Senior Director, Regulatory Operations
    Astellas, United States
  • Ron  Fitzmartin, PhD, MBA
    Ron Fitzmartin, PhD, MBA Senior Informatics Advisor, Office of the Director, CBER
    FDA, United States
  • Thomas  Noto
    Thomas Noto Senior Director, Regulatory Operations
    Lexicon Pharmaceuticals, United States
  • Venkatraman  Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA Senior Vice President and Global Head, Healthcare and Life Sciences
    Orion Innovation, United States
  • Jo  English
    Jo English Vice President, Regulatory Information Management
    Calyx, United Kingdom
  • Jake  Doran
    Jake Doran Head of Global R&D IT
    Bausch Health, United States
  • Michiel  Stam
    Michiel Stam Head of Data Management and Regulatory Information Scientist
    Qdossier, Netherlands
  • Danielle  Beaulieu, PhD
    Danielle Beaulieu, PhD Senior Director, Global Regulatory Business Capabilities
    Bristol-Myers Squibb, United States
  • Joanne  Malia, MS, MSc
    Joanne Malia, MS, MSc Director, Clinical Documentation Management
    Regeneron Pharmaceuticals, United States
  • Karen  McCarthy Schau
    Karen McCarthy Schau Director, Global Clinical Operations
    Vertex Pharmaceuticals, United States
  • Daniel  Orfe, MS
    Daniel Orfe, MS President and CEO
    Regulatory eSubmissions, LLC, United States
  • Stacy  Tegan
    Stacy Tegan Associate Director, Program Management
    Transcelerate Biopharma Inc., United States
  • Kevin  Tompkins, MBA
    Kevin Tompkins, MBA Senior Director, Global Submission Management
    Bristol-Myers Squibb Company, United States
  • Jonathan  Resnick, PMP
    Jonathan Resnick, PMP Project Management Officer, OBI, OSP, CDER
    FDA, United States
  • Virginia  Hussong
    Virginia Hussong Chief, Data Standards Program, CBER
    FDA, United States
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