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Global Pharmaceutical Regulatory Affairs Summit
21-23 October 2025
Hotel Palace BerlinBerlin, DE
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Day 3 - October 23rd

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Day 3 - October 23rd
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Showing 1 of 1 Streams
13:25 - 13:30
Chair's Afternoon Remarks
13:30 - 14:15
Regulatory Optimisation Group (ROG) – Progress & Future Directions

Provide an update on the activities of the ROG, highlighting advancements in digital transformation, process optimisation, and collaboration between Industry and Regulators.

  • Establishing PMS as a shared, validated and trusted source for the EU Network
  • Enhancing data integrity and interoperability
  • Proof of concept of variation optimisation
14:15 - 15:00
Leveraging Learnings: Cross-Industry Use of Data

  • As pharma continues to develop ways to collect, store, and leverage their data, what can we learn from other industries?

    • How are alternative industries ensuring their data is readable, useable, and secure?

    • Which challenges did they experience in refining their platforms and processes? And how were they overcome?

    • Which lessons can pharma companies apply to their own data and submission processes?

  • Opportunities and challenges under new EU data laws and ability to use such data in regulatory submissions

Day 2 - October 22nd
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