The eCTD summit

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GlobalSubmit Presents eCTD Essentials in Multiple Cities this October

posted by bunderwood @ 2:59 PM
Wednesday, September 11, 2013

In recent years eCTD has become the preferred format for regulatory submissions worldwide, and momentum continues to build as mandates take effect in Europe and the United States. Compiling an electronic regulatory submission is a challenging task even for industry veterans who’e worked on multiple projects. Naturally, an organization making the transition from paper to electronic format or compiling a submission for the first time will have questions.

During the month of October an expert panel comprised of GlobalSubmit executives and senior staff will present a crash course on eCTD essentials in multiple cities. Registration for each event is FREE and lunch will be provided. Here are details for the presentations:

Location: Boston Cambridge Marriott
Date: Wednesday, October 2
Time: 11 a.m. – 1:30 p.m. EDT
Registration: Click Here

Location: San Diego Marriott Del Mar
Date: Tuesday, October 22
Time: 11:30 a.m. – 2 p.m. PDT
Registration: Click Here

Location: San Francisco Airport Marriott
Date: Thursday, October 24
Time: 11 a.m. – 1:30 p.m. PDT
Registration: Click Here

Each interactive session is designed to answer any questions you may have and help you develop an understanding of everything that goes into building an electronic regulatory submission. In our experience, addressing your concerns well in advance of your deadline builds confidence and translates into a less stressful submission process. Here is an up-to-date agenda:

eCTD Essentials Agenda

1. Introduction – Origins of eCTD, FDA News, Future of the Industry

2. ecTD Adoption – Deciding When to Adopt and Developing a Timeline

3. Outsourcing vs. In-House Publishing – What Makes the Most Sense for Your Organization, Cloud solutions

4. Process for Building an eCTD – Industry Best Practices and Technologies Available

5. GlobalSubmit’s Approach – Innovative Solutions that Streamline the eCTD Lifecyle

 

If you would like to attend, and have suggestions for topics or questions you would like to submit in advance, please contact marketing@globalsubmit.com.

 

A number of good articles related to eSubmissions have been posted online recently.  Below, a recap based on posts from my twitter account, www.twitter.com/kathie_clark.  

In Standards news:

Finally, a few upcoming conferences have been announced:

 

News Roundup Part 1: Agency News

posted by mr.erhabi511 @ 8:32 PM
Thursday, August 12, 2010

Today’s post is a round-up of recent eSubmission-related news from the agencies, based on posts from my twitter account, www.twitter.com/kathie_clark.  Next time, a roundup of articles and conferences.

The regulatory authorities haven’t put out much in the way of major updates recently, but there have been some updates worth noting:

The individual agencies in Europe have also issued some updates:

As promised, here is an expanded list of posts published recently on my twitter account, this time related to agency news:

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