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Data Integrity — Frequently Asked Questions (FAQ). Version 3

This document contains a collection of frequently asked questions that have been submitted by the industry to the DI taskforce.

The intention of this documents is that this is a living document that will be updated as new questions are opposed to the group.

News & Trends

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Recentes

  • EMA’s ePI Roadmap
  • Sponsor Frequently Asked Questions Clinical Trial Information System (CTIS) Frequently Asked Questions (FAQs) on the Sponsor’s workspace
  • The new CTIS Sponsor Handbook (v6.2, March 2026)
  • New revision of the Q&A document on art. 10(a) interruption of supply published
  • IMDRF Technical Framework for Artificial Intelligence Life Cycle Management” (IMDRF AIML WG N93 – April 2026)
  • New Harmonised Standards under MDR – April 2026
  • EMA/CHMP: Updated Guideline on Active Substances published
  • Data Quality Framework for EU medicines regulation: application to Real-World Data

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