Annual Event Joins Electronic Data Management and Electronic Regulatory Submissions

Today’s entry was provided by Emily Onkka, Director of Project Management and Regulatory Operations at GlobalSubmit and new regular contributor to Theectdsummit.com. Based in San Diego, CA, she will be leading GlobalSubmit’s professional eCTD services, including eCTD compilation, ESG transmission, publishing, quality checking, and best practice implementation. Prior to joining GlobalSubmit, Ms. Onkka was Head of Regulatory Operations...

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Regulatory Submissions: Paper vs. Electronic

I recently attended a Pharma Regulatory Writer’s Conference in Baltimore, and I have to say that I was truly surprised by the number of companies still submitting their regulatory submissions in paper format. The migration from what is still a manually driven, physically intensive process to a simplified automated task may seem daunting, but in reality, half the battle is already won. Applications are no longer written and transcribed...

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PDF Document FAQs

Last month, I attended a conference focused on pharmaceutical regulatory writing and submissions in Baltimore, MD. During the two-day conference, a number of discussions and questions pertained to PDF files. As many of you may have similar questions or experiences, I wanted to share the questions and answers to provide some greater insight into PDFs in relation to electronic submissions. Q: What versions of PDFs are acceptable? A: The...

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How Mergers & Acquisitions Impact Regulatory Operations Part II

Executive management may consider creating a strategic plan for in/out-licensing and mergers and acquisitions. This strategic plan should include the technical aspects of such an undertaking. Such topics as systems to be used, network and security, and staff involvement (including when to involve staff) are important strategies to ensure success.

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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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