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Regulatory Submissions, Information, and Document Management Forum

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Welcoming Remarks and Presentation of the Excellence in Service Award

Session Chair(s)

Venkatraman  Balasubramanian, PhD, MBA

Venkatraman Balasubramanian, PhD, MBA

  • SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
  • Orion Innovation, United States
Mark A. Gray

Mark A. Gray

  • Senior Project Manager, DSB, CBER
  • FDA, United States
Congratulations to our 2023 Excellence in Service Awardees!


Ethan  Chen, MBA, MS, PMP


Ethan Chen, MBA, MS, PMP

  • Director, Division of Data Management Services and Solutions, OBI, OSP, CDER
  • FDA, United States
Karen  McCarthy Schau


Karen McCarthy Schau

  • Director, Risk-based Study Management
  • Vertex Pharmaceuticals, United States
Stacy  Tegan


Stacy Tegan

  • Program Director
  • Transcelerate Biopharma Inc., United States
Michiel  Stam


Michiel Stam

  • Director Regulatory Information Management
  • Qdossier - A Celegence Company, Netherlands