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