Agile For Regulatory Submissions Education

Agile for Regulatory Submissions

Education Series

In the coming weeks, GlobalSubmit will publish a series of six (6) blog articles explaining the theories and practices behind the agile management methodology as it applies to regulatory submissions. 

Register for GlobalSubmit’s Agile for Regulatory Submissions Webinar – Tuesday, November 10

Our series is a derivative of an original work produced by Ken Schwaber and Jeff Sutherland called the Scrum Guide. The focus of the Scrum Guide was creating and sustaining software products. Our Agile for Regulatory Submissions series is focused on compiling submissions that will be sent to regulators for review.

The following links will become active as the articles are published on our eCTD Summit Blog.

Part I – How We Moved to Agile for Regulatory Submissions and Why It Worked

Part II – Defining and Unpacking the Principles of Agile Theory

Part III – The Team for Agile Regulatory Submissions

Part IV – The Design and Execution of Agile Events for Regulatory Submissions

Part V – The Role of Artifacts in the Agile for Regulatory Submissions Process

Part VI – How Important is Complete Transparency When Using Agile Principles for Regulatory Submissions?