Artigos recentes

• Framework for the Use of Digital Health Technologies in Drug and Biological Product Development
• Advancing regulatory science in the EU – mid-point report published
• Amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
• Gestão de Risco no âmbito das Boas Práticas de Distribuição : “Formação muito bem conseguida com aplicabilidade prática”
• EVALUATION GUIDE FOR GMP REGULATORY COMPLIANCE PROGRAMME : Audit Checklist
• MDCG 2023-3: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices
• Ongoing guidance development and deliverables of MDCG Subgroups – March 2023*
• Artificial Intelligence in Drug Manufacturing.