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• FDA draft guidance :“New Clinical Investigation Exclusivity: 3-Year Exclusivity for Drug Products – Questions and Answers.”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