The "Filing eCTD Submissions" conference has been added to ResearchAndMarkets.com's offering.
The eCTD (electronic Common Technical Document) is now mandatory for submissions in the EU and global regulatory agencies are also moving towards the eCTD as a standard submission process
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
The expert speakers will share their practical experiences of the eCTD and discuss how to implement efficient processes to build and publish submissions in both the EU and US. You will consider the eCTD validation criteria and how to prepare for these in your submissions as well as discuss life cycle management. An interactive case study session will explore eCTD submission challenges and logistics and help consolidate learning.
Benefits of Attending
Agenda
Introduction and overview of the eCTD
What are the main components of the eCTD?
Implementing efficient processes to build, publish and deliver regulatory eCTD submissions
The benefits of using MS Word template
Considerations for outsourcing
Practical experiences of submitting eCTDs
Case study - eCTD submission challenges and logistics
Review of eCTD validation criteria
Life cycle management for eCTD submission
Key points to take away for successful eCTD submission
For more information about this conference visit https://www.researchandmarkets.com/r/9wzi0c