Regulatory Submissions, Information, and Document Management Forum

Program Committee

Michelle L. Charles, MPH • Director, Regulatory Affairs, Gene Therapy Program and Orphan Disease Center
University of Pennsylvania, Perelman School of Medicine, United States
Ginny Hussong • Chief, Data Standards Program, CBER
FDA, United States
Sarah Powell, RAC • President
Powell Regulatory Services, United States
Jamie Marie Toth, MS • Director, Head of TMF Operations
Daiichi Sankyo, United States
Venkatraman Balasubramanian, PhD, MBA • Senior Vice President, Life Sciences
Orion Business Innovation, United States
Christian A. Buckley, MBA, RAC • Associate Director, Regulatory Affairs
Astellas, United States
Brooke Casselberry, MS, RAC • Senior Director, R&D Consulting
NNIT, United States
Cindy Chiu • Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States
Jake Doran • Head of Global R&D IT
Bausch Health, United States
Betsy Fallen, RN • Consultant
BAFallen Consulting LLC, United States
Ron Fitzmartin, PhD, MBA • Senior Informatics Advisor, Office of the Director, CBER
FDA, United States
Mark A. Gray • Senior Project Manager, DSS, CBER
FDA, United States
Dominique Lagrave, PharmD • Director, Global Regulatory Affairs and Safety Operations
Amgen, United States
Thomas Noto • Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States
Daniel Orfe, MS • President and CEO
Regulatory eSubmissions, LLC, United States
Vada A. Perkins, DrSc, MSc • Executive Director, Regulatory Policy and Intelligence
Bayer Pharmaceuticals, United States
Michiel Stam • Head of Data Management and Regulatory Information Scientist
Qdossier, Netherlands
Stacy Tegan • Senior Program Manager
Transcelerate Biopharma Inc., United States

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