Recentes

• IMDRF/MC/N2FINAL:2025 (Edition 13) Standard Operating Procedures version 2
• New EU Regulation : Safer Cosmetics Ahead
• CIOMS proposes best practices for AI in pharmacovigilance
• AI Literacy – Questions & Answers
• ICH Guideline M13B on bioequivalence for immediate-release solid oral dosage forms – additional strengths biowaiver – Scientific guideline
• Concept paper on the revision of Part IV Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
• GDP MED 2025 : Mais uma edição marcada pela excelencia em termos de qualidade e relevância dos conteúdos
• Team-NB  Version 3 of Position Paper on the submission of technical documentation according to Annex II and III of the Medical Device Regulation