Le Lézard
Subject: Conference

1-Day Filing eCTD Submissions Course: London, United Kingdom - April 6th, 2020 - ResearchAndMarkets.com


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



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