Lack of Standardized Data Hurting Review

This week’s blog posting is from Laura Wright, who attended the 23rd Annual DIA EDM conference in National Harbor, MD, February 16 through 19. In Laura’s role as Account Manager at GlobalSubmit, she talks to many people in regulatory, clinical and IT roles in the biopharmaceutical industry. Hearing some of their interests and concerns led Laura to attend a session entitled “Regulatory Update: Future Directions”. Here, she offers her...

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Progress for Health Canada’s Electronic Review Program

Well,it’s back to business after the holiday break. As promised, here’s my update on what’s happening at Health Canada. At the recent DIA eSubmissions conference, Health Canada’s Vianney Caron presented an update on eCTD at Health Canada. The E-Review Program The purpose of Health Canada’s E-Review program is to support branch business processes throughout the health product life cycle across product lines using an...

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FDA eCTD Submission Metrics, Role of Study Tagging Files

Announcement: See GlobalSubmit’s website for a brand new presentations page linking to recent agency presentations! GlobalSubmit recently attended two informative DIA conferences: The 8th Annual Electronic Submissions Conference “eCTD: The Adventure Continues” in San Diego The 10th Conference on European Electronic Document Management in beautiful Vienna, Austria During these conferences, industry received updates from a number...

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Europe Reports on Progress of eSubmission Initiative

Rob de Haan, deputy director at MEB, spoke about the status of eCTD at MEB, and also presented a variety of EU statistics, many of them updates from the eCTD Implementation Survey Report published in December of 2008. MEB now has a full e-working environment (although they make almost no use of their eCTD viewer, for reasons Rob didn’t go into). eSubmissions (eCTD and NeeS) for human medicines are mandatory. Case managers and...

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Europe Working to Establish Electronic Submission Gateway

I caught up with Tim Buxton of EMEA at the DIA meeting in June. Tim’s big news is that EMEA’s Electronic gateway will be operational shortly, although he could not release a date. The gateway has already been tested with a variety of submissions. Tim stressed that the EMEA is serious about enforcing the use of eCTD and no longer accepting NeeS as of the published 1 January 2010 deadline. He mentioned that forward-looking companies are...

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