AI’s next Regulatory target: product change/impact assessment
When any change is made to a product or its ...
The Reinvention of Life Science RegOps: is AI changing play?
At Breakthrough 2025, independent regulatory expert Preeya Beczek moderated the panel debate, Regulatory Operations: Driving Progress and Preparing for the Future.
From Planning to Launch: How to Implement a New Safety Database and Maximize ROI
At Breakthrough in Zurich, Felix Arellano, Global Head of Drug Safety at Roche, shared a candid and inspiring account of Roche’s multi-year journey to launch their next-generation safety system: Voyager.
Unlock PV Innovation with GenAI-Powered Modular Solutions
Our recent webinar “Embracing a Modular Strategy for Accelerated Digital Transformation in Safety Case Intake” featured industry experts discussing how leading organizations are leveraging modular, GenAI-powered solutions to seamlessly future-proof their Safety operations and integrate cutting-edge technologies in months, not years.
Breakthrough 2025: The Highlights You Don’t Want to Miss!
Relive the most exciting moments, key insights, and groundbreaking discussions from Breakthrough 2025.
AI is alive among us, whichever route we take: Boehringer Ingelheim’s takeaways from Breakthrough 2025
At Breakthrough 2025, Claudia Lehmann, Head of Global PSPV Operations at Boehringer Ingelheim, joined a user panel discussing the impact of NavaX, the powerful AI and machine learning engine which powers the platform.
Laying the foundations for a GenAI future: Roche’s journey
At Breakthrough 2025, Roche’s Jorge Carmona Toscano will join a panel discussion on emerging IT strategies to maximize the value of data and bed in greater GenAI use.
Sharing data: lessons as Regulatory & Safety/PV teams get closer
At Breakthrough 2025, Hans van Leeuwen, Global Head of Regulatory Affairs Data & Systems at Astellas Pharma, will take part in a panel discussion on the pursuit of greater interoperability between Regulatory and Safety systems.
How to Make Your Case to Attend Breakthrough 2025: AI in Action
Are you eager to attend Breakthrough 2025 this March in Zurich but need to secure approval from your manager or team?
Extracting tangible value from AI in Regulatory Affairs, Compliance & More
In anticipation of a rousing Breakthrough 2025, Regulatory consultant and panel session moderator Preeya Beczek sets out her hopes for this year’s event.
