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Session 4: Application of AI & ML in Drug Development and Approval
Session Chair(s)
Niels Buch Leander, PhD
Associate Vice President, 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)
Intro - Application of AI & ML in Drug Development and Approval
Niels Buch Leander, PhD
NNIT, Denmark
Associate Vice President, Global Head of Regulatory Affairs
Embracing Real World Evidence (RWE) & Robotic Process Automation to transform Regulatory Affairs Submission Process
Susant Mallick, MBA
Cloudhub BV, Netherlands
Founder and CEO, Life Sciences Practice Leader
AI and ML in a Drug Development Perspective
Niels Gronning, MSc
Microsoft, Denmark
Senior Specialist
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