How Mergers & Acquisitions Impact Regulatory Operations Part 1

During the out-licensing process it is necessary for the RegOps group to organize and transfer the information and documentation to the new company. This may include the submissions, labeling, correspondence, and other documentation for the product. Additionally a chronology of the product documents, whether that be hard copy, electronic, or both should be included as an “inventory” check.

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eCTD Mandate to Follow 2-Year Implementation Timeline

The draft guidance will be open to comment for a period of 6 months followed by the release of the final version. It will then be implemented 2 years after the final version, bringing us to mandated electronic submissions in Q2 2015.

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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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