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Short Course or Primer
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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
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Brooke Casselberry, MS, RAC • Associate Vice President
NNIT, United States -
Cindy Chiu • Senior Director, Regulatory Affairs Operations and Quality Management
Merck & Co., Inc., United States -
Peter Terbeek, MBA • Senior Director, Regulatory Operations
Astellas, United States -
Ron Fitzmartin, PhD, MBA • Senior Informatics Advisor, Office of Regulatory Operations, CBER
FDA, United States -
Thomas Noto • Senior Director, Regulatory Operations
Lexicon Pharmaceuticals, United States -
Venkatraman Balasubramanian, PhD, MBA • SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
Orion Innovation, United States -
Jo English • Vice President, Regulatory Information Management
Calyx, United Kingdom -
Jake Doran • Head of Digital
MAPS Public Benefit Corporation (MAPS PBC), United States -
Michiel Stam • Director Regulatory Information Management
Qdossier - A Celegence Company, Netherlands -
Danielle Beaulieu, PhD • Senior Director, Global Regulatory Business Capabilities
Bristol-Myers Squibb, United States -
Joanne Malia, MS, MSc • Director, Development Records Management
Regeneron Pharmaceuticals, United States -
Karen McCarthy Schau • Director, Risk-based Study Management
Vertex Pharmaceuticals, United States -
Daniel Orfe, MS • President and CEO
Regulatory eSubmissions, LLC, United States -
Stacy Tegan • Program Director
Transcelerate Biopharma Inc., United States -
Kevin Tompkins, MBA • Executive Director, Regulatory Information & Submission Management
Bristol Myers Squibb, United States -
Jonathan Resnick, PMP • Project Management Officer, OBI, OSP, CDER
FDA, United States -
Ginny Hussong • Chief, Data Standards Program, CBER
FDA, United States