Artigos recentes

• European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
• Quality documentation for medicinal products when used with a medical device- effective from 1/01/2022
• Artificial intelligence in medicine regulation
• Clinical Trial Information System (CTIS) – Sponsor Handbook
• Sistema europeu de ensaios clínicos lançado em janeiro
• EMA new guidelines on veterinary pharmacovigilance
• Veterinary product information templates
• MDCG 2021-19 Guidance note integration of the UDI within an organisation’s quality management system