The eCTD Summit Celebrates 8th Anniversary with New Layout
Jan28

The eCTD Summit Celebrates 8th Anniversary with New Layout

While the online world has radically changed during the past 8 years, our approach of creating quality content has not. The eCTD Summit blog will continue to be a source of objective information on all things eCTD and regulatory submissions. Articles on the site are based on facts and stripped of bias. We want the site to be a trusted place our readers can regularly return to for updates on industry news, initiatives and best practices.

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The Definitive FDA Module 1 Update – DIA eRI 2015
May05

The Definitive FDA Module 1 Update – DIA eRI 2015

This year’s DIA eRegulatory and Intelligence conference in Philadelphia, PA May 11-13 is the definitive source of information on the FDA’s transition to a new Module 1. The Agency is scheduled to provide an M1 implementation update covering timelines and expectations on Tuesday, May 12th during Session 1, Track 2. The session is scheduled to run 8:30 a.m. – 10 a.m.

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Connect with GlobalSubmit at DIA 2014

The DIA conference most attuned to our segment of the industry returns to the East Coast this year September 22-24 at the Omni Shoreham Hotel in Washington, DC. GlobalSubmit will have a healthy presence at DIA EDM and ERS – exhibiting on the show floor and presenting during a number of educational sessions. We encourage you to visit us at Booth #201 during the conference or schedule a time to meet with the GlobalSubmit team on or off...

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Abstract Deadline Extended for the DIA EDM and ERS Conference 2014

The call for session abstracts is open and the deadline has been extended to May 27, 2014. In years past, this meeting has served as a forum for peer-to-peer engagement. Attendees share their experiences and solutions to the challenges faced with electronic submissions and electronic document management within their respective organizations and working with partners and outsourcing providers. Case studies often make for compelling...

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GlobalSubmit Presents eCTD Essentials in Multiple Cities this October

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...

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