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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

Procurar

Recentes

  • Update to EU GMP Guidelines – Revised Annex 19 on Reference and Retention Samples
  • FARMACOVIGILÂNCIA nível avançado : Formação completa con casos práticos
  • FDA DRAFT GUIDANCE :Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
  • European Biotech Act: Positioning EU as Biotech Powerhouse
  • CIOMS Glossary of ICH Terms and Definitions. Version 10
  • Guidance on standardisation for medical devices Appendix: Transition to the ‘EU REP’ symbol in EN ISO 15223-1
  • MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use
  • Commission Implementing Decision amending Implementing Decision (EU) 2021/1195 as regards the harmonised standard for symbols to be used with information to be supplied by the manufacturer

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