• Inicio
  • Formações
  • Formação à Medida
  • News & Trends
  • Sobre nós
  • Contacto

New CTIS Guidance for Sponsors- Version 6.0

 

The European Medicines Agency (EMA) has published Version 6.0 of the Sponsor Handbook: CTIS User Guidance on the Sponsor’s Workspace (EMA/186412/2021).

This comprehensive update supports sponsors in navigating the Clinical Trial Information System (CTIS), aligning with the ongoing transformation of clinical trials in the EU.

Published: 9 July 2025

News & Trends

Procurar

Recentes

  • Plano de Controlo de Qualidade e Conformidade Legal de SUPLEMENTOS ALIMENTARES: ” Formação muito útil para o desempenho das minhas funções “
  • MHRA Registration of medical devices
  • The Use of Data in Public Health. Understanding the Potential for Artificial Intelligence in Medicine
  • UK Government confirms indefinite recognition of CE marked medical devices
  • Methodological Principles for the Assessment of Section 5.1 of the Summary of Product Characteristics
  • Good manufacturing practice (GMP) Multistakeholder workshop on expert contributions to artificial intelligence guidance development (Annex 22)
  • PIC/S PE 009-18 – Guide to GMP for Medicinal Products | Part I
  • EMA Updates Information Page on Bioequivalence Guidelines

91 257 00 03 (Chamada para a rede móvel nacional)
info@formiventos.com

  • Follow
  • CLIENTES & TESTIMONIALS
  • ASSOCIAÇÕES OFICIAIS
  • CERTIFICAÇÕES E CREDITAÇÕES
  • ADVISORY BOARD
  • Política de Privacidade
  • Contacto