Today’s entry was provided by Matthew J. Neal, Director of Knowledge Management & Innovation in Global Regulatory Affairs & Safety at Amgen, Inc. in Thousand Oaks, CA. He led the Regulatory Operations group there for seven years and managed submissions for GSK in Philadelphia, PA for 7 years before that.
So, last time, I told you about assembling a team of believers. Those believers are the “customers” you serve on both sides of the fence in regulatory operations. Not only are you getting documents from all the different members of the extended filing team (Regulatory, CMC, Pre-Clinical, etc.), but you’re then serving a different master in your health authority. If you need to review, please read the previous post.
This time, I want to focus on getting the most out of the tools and process which drives your efficiency. Getting to the heart of the matter, operations functions of all shapes and sizes exist – and so do solutions to meet those needs. While it is true that you can create a valid eCTD with some very simple and inexpensive software tools, there is no way I would want to do it by those means.
To find more information click here: THE eCTD SUMMIT: Regulatory Submissions Made Easy, Part II - By Matthew J. Neal
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