Version 3.9 brings significant changes to the implementation of the Master UDI, it is essential that you keep up to date to ensure compliance with European regulations
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Recentes
- FDA Biosimilar Development – Q&A Guidance: Q&As on Biosimilar Development and the BPCI Act
- NDSG workplan 2026-2028 : Data and AI in medicines regulation
- New guidance on the conduct of clinical trials during public health emergencies
- Nova lei regula ensaios clínicos de medicamentos para uso humano em Portugal
- FDA draft guidance :“New Clinical Investigation Exclusivity: 3-Year Exclusivity for Drug Products – Questions and Answers.”
- webinar INTELIGÊNCIA ARTIFICIAL NA INDÚSTRIA FARMACÊUTICA :IA EM CONTEXTO GxP (Annex 11, 22, EU AI Act , GAMP®)
- GESTÃO da DISPONIBILIDADE do MEDICAMENTO: “Formação muito útil !
- IMDRF Playbook for Medical Device Regulatory Reliance Programs