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美国食品药品监督管理局数字转型:技术的未来以及如何准备
十月 27, 2021
按需随选的网络研讨会

As Life-Science manufacturers embrace new technologies to speed time to market and products become more complex, the FDA has created an Office of Digital Transformation (ODT) to support the effective review, approval, and regulation of human drugs, biological products, and medical devices.

To achieve its goals, FDA is doubling down on cloud technologies and the use of shared inter-operable data and structured information. This approach enables longitudinal evaluation and modern capabilities like artificial intelligence (AI) for prediction and blockchain for track & trace. It also expedites the adoption of computerized modeling and simulation to inform clinical trial design, predict clinical outcomes, demonstrated safety and effectiveness, identify relevant patient populations, and support regulatory submissions.

Attend this webinar to learn:

  • How FDA’s digital transformation will impact you and your organization
  • What are FDA’s Data Modernization Action Plan (DMAP) and Technology Modernization Action Plan (TMAP) and how this impacts the Life-Science industry
  • How FDA plans on implementing artificial intelligence (AI), machine learning (ML) and Natural Language Processing (NLP)

Who Should Attend?

  • CIOs
  • Digital Transformation Officers
  • Informaticists
  • IT Professionals
  • Quality Management
  • Regulatory Professionals
  • Research & Development
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