S0801 - Digital Transformation and Structured Data: the Future of Regulatory Operations

Wed, Mar 19, 2025 · 8:30–9:40 AM CET Sydney Room, Congress Center Basel

About this session

In this highly interactive session, all participants will be invited to participate in multistakeholder roundtable discussions dedicated to the future of regulatory operations, specifically on what concerns digital transformation and structured data. We will explore challenges, opportunities and lessons learned, and jointly define the next steps needed to drive the digital transformation of regulatory operations.

Programme:
- Table Facilitators — Zaide Frias, Tim Powell, Kate Porch, Jamie Morisco, Luis Miranda, Michael Abernathy, Rodrigo Palacios
- 1. Setting the Scene: Achieve Global Data Standards Using Artificial Intelligence — Jamie Morisco, Luis Miranda
- 2. Setting the Scene: Digitizing and Exchanging Regulatory Content Leveraging 21st Century Technologies — Michael Abernathy
- 0. Introduction — Tim Powell

Speakers

Tim Powell

Director, Submission Sciences, Global Safety and Regulatory Sciences · Biogen

Chair
Kate Porch

Director, elabeling Lead, Global Labeling, Global Regulatory Affairs · Johnson & Johnson

Speaker
Rodrigo Palacios

Regulatory Policy Lead · F. Hoffmann-La Roche

Speaker
Luis Miranda

Director, GRA Digitalization Lead · CSL

Speaker
Zaide Frias

Head of Digital Business Transformation, Chief Digital Officer · European Medicines Agency

Speaker
Jamie Morisco

Vice President · Glemser Technologies

Speaker
Michael Abernathy

Executive Director, Global Regulatory Affairs · Amgen Inc.

Speaker