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REGULATORY MEDICAL WRITING
Lisboa, 3 de dezembro de 2024
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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