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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

  • Plano de Controlo de Qualidade e Conformidade Legal de SUPLEMENTOS ALIMENTARES: ” Formação muito útil para o desempenho das minhas funções “
  • MHRA Registration of medical devices
  • The Use of Data in Public Health. Understanding the Potential for Artificial Intelligence in Medicine
  • UK Government confirms indefinite recognition of CE marked medical devices
  • Methodological Principles for the Assessment of Section 5.1 of the Summary of Product Characteristics
  • Good manufacturing practice (GMP) Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22)
  • PIC/S PE 009-18 – Guide to GMP for Medicinal Products | Part I
  • EMA Updates Information Page on Bioequivalence Guidelines

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