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FDA’s Digital Transformation: The Future of Technology and How to Prepare

Live webinar

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

Thank you for registering!

Our Speakers
Kevin Trimm
Vice President of Product Management, Certara
Kevin brings over 17 years of experience in pharmaceutical research and software development. He spearheads product strategy for Certara’s Data Science platforms and leads implementation of technology solutions, collaborating closely with clients.
Daniel Matlis
Founder and President, Axendia
Daniel has three decades of industry experience spanning the Life-Science value network. He is an active contributor to FDA’s Case for Quality Initiative (since 2014), is a member of FDA’s Advisory Council on Modeling, Simulation and in-Silico Clinical Trial, and has co-chaired the Product Quality Outcomes Analytics initiative with Agency officials.
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