REFERÊNCIAS:
.-EMA: Questions and answers: Good manufacturing practice – Data Integrity Section
.-FDA: FDA Data Integrity Guidance
.-MHRA: MHRA Data Integrity Definitions and Guidance
.-PIC/S: PIC/S Guidance
.-WHO: WHO Guidance
Artigos recentes
- 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
- The FDA finalized its guidance on the form and content requirements for unique device identifiers (UDI)
- 4th Edition of the ISO 15223-1:2021 Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
- Fichas informativas com informação básica para todos os stakeholders sobre os novos Regulamentos dos Dispositivos Médicos e Dispositivos Médicos para o diagnóstico in vitro
- EXPAMED CECP (Opinion in the context of Cllinical Evaluation Consultation Procedure).
- EMA has published version 2.1 of the Implementation Guide for the ISO IDMP standards