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Artigos recentes

  • IMDRF :Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
  • Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
  • CLINICAL TRIALS REGULATION:(EU) Nr. 536/2014.
  • EMA has published the EU IDMP Implementation Guide version 2.0
  • Guideline on good pharmacovigilance practices (GVP) 4 Module XVI – Risk minimisation measures: selection of tools and 5 effectiveness indicators (Rev 3)
  • EUDAMED NEWS: management of legacy devices.
  • GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC vs 4 : KEY CHANGES
  • GVP: EMA revised risk minimization module
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