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Signal management: EMA e-learning course

These training materials seek to further improve understanding of signal management within the European medicines regulatory network and develop best practice in signal management.

The course gives an overview of best practice in signal management.

Main topics discussed

  • Five steps in signal management: detection, prioritisation, validation,  confirmation and assessment.
  • Most relevant sources of information used in signal management
  • Reports of special interest

 

LEARNING MATERIALS

  • Signal management: e-learning course
  • SCOPE training: Signal Management Best Practice Guide (PDF/1.57 MB)

News & Trends

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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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