The FDA will 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 and GlobalSubmit titled, "Background and Drivers to the eCTD Next Major Version / Regulated Product Submission,” on Thursday, October 4th at 1:00 p.m. EDT.

During this discussion, Jason will provide detailed reasons why a new standard was created, the timelines when the standard will be complete, what each of the agencies' plans are, and the major differences between eCTD version 3
and 4.

1. Why eCTD v4 was developed
2. What the agency's plan is for eCTD v4
3. What’s the difference between eCTD v4 and eCTD v3

Presenting Expert:

Jason Rock, CTO at GlobalSubmit

October 4, 2012
1:00 PM EDT
Or click the link below:
Register Now

About GlobalSubmit
About Cato Research

At GlobalSubmit, we are trusted advisors to the FDA and to our Life Sciences customers around the world. Our principals sit on the boards of standards development organizations including the International Conference on Harmonisation (ICH) and Health Level 7 (HL7). Our thought leaders are world renowned for their expertise in electronic document management best practices. We share that knowledge with our customers every day, so that they stay ahead of the competitive curve when submitting their eCTDs.