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Program Committee

  • Betsy  Fallen, RN
    Betsy Fallen, RN Principal BAFallen Consulting, LLC, United States
  • Gary M. Gensinger, MBA
    Gary M. Gensinger, MBA Senior Advisor, Office of New Drugs, CDER FDA, United States
  • Christian A. Buckley, MBA, RAC
    Christian A. Buckley, MBA, RAC Associate Director, Regulatory Affairs Astellas, United States
  • Mark A. Gray
    Mark A. Gray Senior Project Manager, BSS, CBER FDA, United States
  • Virginia  Hussong
    Virginia Hussong Acting Director, Division of Data Management Services & Solutions, OBI,OSP,CDER FDA, United States
  • Daniel F. Orfe, MS
    Daniel F. Orfe, MS President & CEO Regulatory eSubmissions, LLC, United States
  • Emily  Onkka
    Emily Onkka Senior Director, Regulatory Affairs Pfenex, Inc., United States
  • Laura J. Sherman, MBA
    Laura J. Sherman, MBA Training Partner, Clinical Business Operations Vertex Pharmaceuticals, Inc., United States
  • Stacy J. Tegan
    Stacy J. Tegan Senior Consultant, Accelerated R&D Services Accenture, United States
  • Hans  van Bruggen, MSc
    Hans van Bruggen, MSc Director and Senior Regulatory Affairs Consultant eCTDconsultancy and Qdossier, Netherlands
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