Digital Transformation in Regulatory Tools and Dossier Submission

Description: In recent years, the European Medicines Agency (EMA) has made significant strides in its digital framework through the introduction of several key technologies. This session will delve into the current state by recognizing EMA's technologies delivery as a pivotal driver in expediting the overall efficiency of the European network of regulatory medicines agencies emphasizing how strategic priorities definition and streamlined data governance contribute to the digitalization acceleration and data-driven operations.

This session will also explore the feasibility of integration, interoperability, and potential evolution with emerging cloud-based technology systems. By examining the functional capabilities of these technologies, the aim is to explore how these systems can be compatible and linked with advanced cloud-based technologies and the incorporation of Artificial Intelligence.

Strategies that help for a shift towards cloud-based dossiers and data sharing will be explored, highlighting lessons learned from the past 3 years pilots. This session will provide regulatory stakeholders’ insights into overcoming barriers and fostering widespread adoption of cloud-based regulatory systems, highlighting value, particularly in facilitating international regulatory collaborative procedures.

Panellists will highlight the transformative impact these technologies are expected to have on exchanges between EU's digital tools and other regulatory stakeholder systems, setting the stage for future advancements that enhance regulatory processes and submission frameworks within the EU and beyond.