Millennium’s Solution for Integrated Submission Planning and Tracking and Regulatory Information Mgmt: GOPATS System

Rebecca Greenberg – Associate Director at Millennium Pharmaceuticals, Inc

Millennium Pharmaceuticals has implemented an integrated Regulatory Submission Planning and Tracking System using Microsoft SharePoint, Project Server and Master Data Services that incorporates many key elements of Regulatory Information Management.  The system facilitates submission planning in a manner that mirrors best practice techniques used by Submission Managers including capacity planning, resource management and Gantt-based scheduling.  The solution leverages a common data model and robust data dictionaries that eliminate redundant data entry and improve data quality.  It also provides an expandable set of reports that support current and forward looking resource planning and operational metrics collection that address some of the Millennium’s highest priority RIM-related concerns.  An agency commitment tracking feature provides a knowledge base for submission-related Q&R and allows Millennium to respond consistently to agency inquires.

In this session you will learn how to leverage standard project management tools and techniques to plan and execute regulatory submissions.  In addition, you will develop an understanding of how to address common aspects of Regulatory Information Management using the Microsoft SharePoint platform.