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  • Feb 04, 2021

    Regulatory Content and Submissions Primer: Content from Authoring Through Archive

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  • Feb 05, 2021

    Short Course 1: Regulatory Considerations for Blockchain in Clinical Research and Drug Development

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Program Committee

  • Brooke Casselberry, MS, RAC
    Brooke Casselberry, MS, RAC • Associate Vice President
    NNIT, 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 Regulatory Operations, CBER
    FDA, United States
  • Thomas Noto
    Thomas Noto • Senior Director, Regulatory Operations
    Lexicon Pharmaceuticals, United States
  • Venkatraman Balasubramanian, PhD, MBA
    Venkatraman Balasubramanian, PhD, MBA • SVP and Global Head, Industry Solutions - 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 Digital
    MAPS Public Benefit Corporation (MAPS PBC), United States
  • Michiel Stam
    Michiel Stam • Director Regulatory Information Management
    Qdossier - A Celegence Company, 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, Development Records Management
    Regeneron Pharmaceuticals, United States
  • Karen McCarthy Schau
    Karen McCarthy Schau • Director, Risk-based Study Management
    Vertex Pharmaceuticals, United States
  • Daniel Orfe, MS
    Daniel Orfe, MS • President and CEO
    Regulatory eSubmissions, LLC, United States
  • Stacy Tegan
    Stacy Tegan • Program Director
    Transcelerate Biopharma Inc., United States
  • Kevin Tompkins, MBA
    Kevin Tompkins, MBA • Executive Director, Regulatory Information & Submission Management
    Bristol Myers Squibb, United States
  • Jonathan Resnick, PMP
    Jonathan Resnick, PMP • Project Management Officer, OBI, OSP, CDER
    FDA, United States
  • Ginny Hussong
    Ginny Hussong • Chief, Data Standards Program, CBER
    FDA, United States
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