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avatar for Bakul Patel

Bakul Patel

FDA, United States
Chief Data Officer, OCD, CDRH
BAKUL PATEL is the Director for Digital Health Center of Excellence, at the Food and Drug Administration (FDA). Mr. Patel is responsible for providing leadership, development, implementing, execution, management and setting strategic direction and regulatory policy and coordinate scientific efforts for digital health, software and emerging technologies. Mr. Patel, in 2013, created the term “software as a medical device”(SaMD) and under his leadership the International Medical Device Regulators Forum (IMDRF) established the globally harmonized definition of SaMD. Mr. Patel subsequently led global regulators at IMDRF to create and author the globally harmonized regulatory framework for SaMD.

My Speakers Sessions

Thursday, June 17
 

12:00pm EDT

 
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  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Data Standards
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClin Dev-EarlyPhaseCR
  • 07: ProjMgt-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Posters
  • 18: Networking Opportunities
  • 19: Short Courses
  • 20: Early Access Content
  • 21: InnovationTheaters
  • 22: Solution Circles
  • 23: Spotlight Symposia
  • 24: Lunch-and-Learn
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