Presented by
Management Forum
This intensive one-day course will provide an overview of eCTD submissions and clarify the main components required for a successful submission.
★★★★★ "Excellent webinar summarising the modular approach of eCTD and the differences between M1 for differ... more"
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:This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
The course will be beneficial to regulatory professionals involved in the preparation of electronic submissions. It will also be of interest to anyone responsible for providing content for the eCTD or who wants to understand the eCTD better.
Excellent webinar summarising the modular approach of eCTD and the differences between M1 for different regions/countries.
Found information on content versus context really important from a regulatory operations point of view and quality control aspects.
Publishing eCTD readiness section also helpful - discussing components of headers/footers, redundant info, hyperlinking, appendices and cross referencing.
Thoroughly enjoyed watching the live demo on building the submission in Docubridge, seeing the validation publish warning errors and backbone file explanations.
Thank you very much indeed.
Jan 16 2023
Jillian Green
Assistant Regulatory Operations Manager, Kalvista Pharmaceuticals
Jan 16 2023
Great webinar, and showed that it worked for people that need a general understanding - whether new or not. Really engaging, great presentation and explanation. Pitched at the perfect level
Matt Tyler
Director of Business Development, Celegence
United Kingdom
Denmark
Netherlands
Australia
France
Germany
Israel
Italy
Korea, Republic Of
Mexico
Spain
Switzerland
United States of America
1 day
Typical duration
Pricing from:
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: