Free Educational Webinar: Regulatory Electronic Submissions: eCTD v4 Background and Drivers

Presentation Details: The FDA is looking to mandate electronic submissions in the next few years. At the same time, they and other regulators are looking to upgrade the eCTD standard. Why would the FDA mandate electronic submissions and change the standard at the same time? Jason Rock, Chief Technical Officer at GlobalSubmit, will provide greater insight into this topic during a free educational webinar jointly hosted by Cato Research...

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eCTD Validation Criteria v2.2 FAQs

GlobalSubmit recently held an educational webinar on the Understanding the New FDA Validation Criteria. The purpose of the webinar was to provide an overview of the US FDA’s draft version of the new “Specification for eCTD Validation Criteria,” which outlines many of the new error conditions that the FDA will be checking for in the next version of its validation software. During the webinar, facilitated by Daniel Clark, Sr. Manager,...

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Free Webinar: Understanding the New FDA Validation Criteria

GlobalSubmit is offering a free educational webinar on Understanding the New FDA Validation Criteria on Thursday, October 20th at 11:00am EDT. During this discussion, we will focus on some of the more important changes to the criteria, when the new validation criteria will go into effect, best practices for ensuring your application is free of technical errors, and more.

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Latest FDA eCTD Validation Criteria Draft Guidance Adds, Removes Error Conditions

The US FDA has posted a draft version of a new “Specification for eCTD Validation Criteria” which can be found here. This document outlines many of the new error conditions that the FDA will be checking for in the next version of the validation software. I will be highlighting some of the more important changes to the criteria.

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Pass, Fail, Best Practice Introduced into EU eCTD Validation Criteria
Jul18

Pass, Fail, Best Practice Introduced into EU eCTD Validation Criteria

The European region is going to put new validation criteria into effect in September 2011. The previous priority levels of A, B, and C have been removed, and have been replaced by Pass, Fail, and Best Practice.

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