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.
Agenda and speakers:
Application of AI & ML in Drug Development and Approval
Niels Buch Leander, PhD (Chair of the session), Global Head of Regulatory Affairs At NNIT.
Embracing Real World Evidence (RWE) & Robotic Process Automation to transform Regulatory Affairs Submission Process
Susant Mallick, MBA, Leader and Evangelist, Healthcare and Life Sciences, EMEA, Amazon, Netherlands
AI and ML in a Drug Development Perspective
Niels Gronning, MSc, Senior Specialist, Microsoft, Denmark