Recentes

• Study supporting the monitoring of the availability of medical devices on the EU market
• Corrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities and joint assessment teams
• Iniciativa para melhorar a eficiência na aprovação de novos medicamentos na UE
• Consulta pública a decorrer para Projeto de Regulamento de Execução sobre consultas científicas conjuntas de medicamentos
• EUDAMED user guide Guidelines on Data Exchange with EUDAMED
• Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
• Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle
• Guidance for best practices for clinical trials