The ECA GMP Auditor Association has published the first 4 draft chapters of the new GMP Auditors Reference Handbook. You can access the draft chapters after free registration here https://lnkd.in/erX69ZeH
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