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Recentes

  • ICH HARMONISED GUIDELINE GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R3) Annex 2 .Final version
  • Team-NB Position Paper: MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus document
  • 2025 AI Observatory report
  • The EU new standard template covering recruitment and informed consent procedures.
  • EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
  • MEDTECH EUROPE : An Improved Regulatory Framework: What Do Europe’s Diagnostics Need?
  • European Data Protection Board public consultation on the draft Guidelines on the processing of personal data for scientific research
  • Statistical Approaches to Establishing Bioequivalence

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