We are excited to be invited by Sindusfarma to conduct a 2-day workshop, offering crucial insights to support the Brazilian pharmaceutical industry in preparing for eCTD v4.0. The workshop will provide an overview of global and local developments in implementing eCTD v4.0 alongside essential structure and terminology. You will also learn practical strategies for adjusting processes and integrating solutions to streamline eCTD dossier submissions to ANVISA. We’re here to assist with this transition and answer your questions to ensure a smooth shift to eCTD v4.0.
Our expert speakers include some of our valued partners in Brazil, Milena Barrozo from Vita Pharma and Juliana Schwarz Rocha from N. G. Reis Consultoria Ltda. Together with Anjana Pindora-Rettenberger, Director of Product Strategy at EXTEDO and an expert on eCTD v4.0, they will share deep insights throughout the workshop.
Date: 23 and 24 September 2024
Time:
09:00 AM - 12:00 PM BRT
02:00 PM – 05:00 PM CEST
08:00 AM – 11:00 AM EDT
Good to know:
The webinar will be conducted in Portuguese and English, with translations available and the opportunity to ask questions.
The Programme includes:
- Do CTD ao eCTD: Status atual da implementação do formato CTD e eCTD no Brasil |
From CTD to eCTD: Current status of CTD e eCTD format implementation in Brazil - Introdução ao eCTD v4.0 | An introduction to eCTD v4.0
- Explorando o CVs e IDs do eCTD v 4.0 | Exploring eCTD v4.0’s CVs and IDs
- As vantagens dos documentos no eCTD v4.0 | The advantages of documents in eCTD v4.0
- Revendo os principais conceitos do eCTD v4.0 | Reviewing the Key Concepts of eCTD v4.0
- Navegando as submissões em eCTD v4.0 | Navigating eCTD v4.0 submissions
- Perguntas e Respostas | Questions & Answers
Palestrantes | Speakers
|
Milena Barrozo Co-founder and Director at Vita Pharma |
Juliana Schwarz-Rocha |
|
Anjana Pindoria-Rettenberger Director of Product Strategy, EXTEDO |