Agile Regulatory Publishing Team
Oct08

Agile Regulatory Publishing Team

A team using the Agile for Regulatory Submissions methodology consists of a Submission Owner, Publishing Team, and a Submission Coordinator. Agile teams are self-organizing and cross-functional. Self-organizing teams choose how best to accomplish their work, rather than being directed by others outside the team. Cross-functional teams have all competencies needed to accomplish the work without depending on individuals outside of the team structure. The team model integral to Agile for Regulatory Submissions is designed to optimize flexibility, creativity, and productivity.

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The Agile Methodology and Regulatory Publishing
Sep24

The Agile Methodology and Regulatory Publishing

Agile is a process framework that has been used to manage complex product development since the early 1990s. Working within the Agile framework, you can employ various processes and techniques. For the purposes of this article and our entire series of articles, the relative efficacy of regulatory publishing practices guided by the Agile methodology are made clear so that you can understand the process and its advantages.

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How We Moved to Agile for Regulatory Submissions and Why It Works
Sep10

How We Moved to Agile for Regulatory Submissions and Why It Works

Agile is a process framework that has been used to manage complex product development since the early 1990s. Working within the Agile framework, you can employ various processes and techniques. For the purposes of this article and our entire series of articles, the relative efficacy of regulatory publishing practices guided by the Agile methodology are made clear so that you can understand the process and its advantages.

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The Case for Tracking Regulatory Submissions
Dec15

The Case for Tracking Regulatory Submissions

The Submission Tracker assigns key dates to deliverables, for example, when a deliverable will be provided for publishing and when certain tasks related to that deliverable must be completed to in order to promote it to submission ready. The tracker is used to determine if submission content is being provided according to schedule and if publishers are completing tasks on time.

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Early Preparations for Your Establishment Registration SPL
Jul09

Early Preparations for Your Establishment Registration SPL

When the conversation turns to Structured Product Labeling (SPL) our first thought is often about Prescribing Information. But as the US FDA and other regulatory bodies modernize review processes, electronic submissions are having an impact across more and more communications. Establishment Registration is one of the more critical SPL submissions and must be submitted annually to the FDA in a narrow window.

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