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
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- Submission of vigilance reports to Notified Bodies under EU MDR & IVDR
- FUTURE GOVERNANCE OF MEDICAL TECHNOLOGIES IN EUROPA. Joint discussion paper .
- Joint strategy sets direction of EMA and EU medicines regulatory agencies to 2028
- MDCG 2020-16 rev.4 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746
- Article 10a MDR / IVDR: Notification in Case of Interruption or Discontinuation of Supply Decision Guide Flowchart
- New Qualification & Validation Guidelines for Pharma in 2025
- ENISA Cybersecurity Maturity & Criticality Assessment of NIS2 sectors
- EMA FAQs How to submit an annual safety report and respond to related RFIs