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Regulatory Submissions, Information, and Document Management Forum


Welcome and Opening Remarks

Session Chair(s)

Sudip  Parikh, PhD

Sudip Parikh, PhD

  • Senior Vice President and Managing Director, DIA Americas
  • DIA, United States
Welcome and Opening Remarks

Speaker(s)

Sarah  Powell, RAC

Program Co-Chair

Sarah Powell, RAC

  • President
  • Powell Regulatory Services, United States
Jamie Marie Toth, MS

Program Co-Chair

Jamie Marie Toth, MS

  • Director, Head of TMF Operations
  • Daiichi Sankyo, United States
Michelle L. Charles, MPH

Program Co-Chair

Michelle L. Charles, MPH

  • Director, Regulatory Affairs, Gene Therapy Program
  • University of Pennsylvania, Perelman School of Medicine, United States
Virginia  Hussong

Program Co-Chair

Virginia Hussong

  • Chief, Data Standards Program, CBER
  • FDA, United States