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Future of Evidence and Smart Health Conference

Leveraging RWE to advance healthcare decision-making.


Session 4: Application of AI & ML in Drug Development and Approval

Session Chair(s)

Niels Buch Leander, PhD

Niels Buch Leander, PhD

  • Global Head of Regulatory Affairs
  • NNIT, Denmark
This session will bring together leading technology providers to combine a focus on the drug development approval process with the data stemming from patients’ use of the medicine approved. From Regulatory Affairs, the perspective is on streamlining the approval process by reference to the right data and on demonstrating and maintaining a safety profile, supported by the patients’ observations. However, the role of the patient is rapidly changing due to technology, and this session will demonstrate and discuss the technologies that will potentially transform the approval process and the safety monitoring of the drugs.

Speaker(s)

Niels Buch Leander, PhD

Intro - Application of AI & ML in Drug Development and Approval

Niels Buch Leander, PhD

  • Global Head of Regulatory Affairs
  • NNIT, Denmark
Susant  Mallick, MBA

Embracing Real World Evidence (RWE) & Robotic Process Automation to transform Regulatory Affairs Submission Process

Susant Mallick, MBA

  • Leader and Evangelist, Healthcare and Life Sciences,
  • Amazon Web Services, Netherlands
Niels  Gronning, MSc

AI and ML in a Drug Development Perspective

Niels Gronning, MSc

  • Senior Specialist
  • Microsoft, Denmark

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