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CTD MODULO 3
Lisboa, 26 de fevereiro de 2025
GESTÃO de ALTERAÇÕES aos termos de AIM
Lisboa, 20 de março de 2025
Como implementar, rever e avaliar CAPAs
Lisboa, 27 de maio de 2025
PROMOTIONAL REVIEW de DISPOSITIVOS MÉDICOS : Rotulagem, Packaging e Publicidade
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Recentes
Final version of its Guideline for Good Clinical Practice E6(R3). Adopted on 6 january 2025
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ICH Q4B(R1) Guideline on evaluation and recommendation of pharmacopoeial texts for use in the ICH regions Step 5
Inter-association joint position paper on Electronic Product Information
MDCG 2023-3 rev.2 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – January 2025
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