Will Data-Driven Regulatory Science Stimulate Innovation and Initiate a New Regulatory Paradigm?

Description: The growth of digital technology is exponential and digitilisation is touching all part of the regulatory process. Ranging from novel data sources to new AI tools used within the regulatory review throughout the product lifecycle. As more and more digital technologies become increasingly embedded in our regulatory landscape are we sufficiently and effectively exploring how a truly data-driven approach to medicines regulation requires reshaping our current regulatory frameworks? Both nationally and in support of global harmonization?
While new digital tools offer a more efficient way to deliver the status quo we should also explore how these innovations can drive the next generation of regulatory science and may even stimulate the creation of new regulatory paradigms.
In this session we will explore the opportunities, needs and challenges encountered in the shift to a truly data-driven environment for medicine regulation across the product lifecycle and who is responsible for generating this data. We will discuss if different approaches could help to drive innovation and efficiency in regulatory science and evolve current regulatory paradigms.