About the DIA Event

• Dates of Event: February 12-14, 2024
• Location: North Bethesda, MD
• Astrix Booth #307

Register for the forum here.

Event Overview

The last few years have shed light on the importance of operational efficiency of the management of regulatory information to ensure quality regulatory submission to health authorities. We have seen how the ability to perform at this level has allowed drug companies to bring therapeutics and vaccines to patients faster. At DIA’s Regulatory Submissions, Information, and Document Management (RSIDM) Forum, we will hear from industry and regulatory stakeholders working across the scope of regulatory information to examine current and evolving data standards and requirements and effective regulatory information management approaches to align related people, processes, and technology. New for 2024, our Forum brings a refreshed set of tracks and focus areas, equipping our attendees with invaluable insights on how to build and sustain successful RSIDM foundations, optimize their current processes and procedures, adopt innovative technologies, and achieve regulatory excellence. This Forum provides multiple opportunities for networking, knowledge sharing, and education for both business and technology-focused attendees at all levels.

About the Astrix Presentation

• Title:  Evolving a Sponsor RIM Organization – Supporting Regulatory Excellence leveraging COEs and centralized capabilities
• Date/Time: February 13th at 3:10pm
• Presenters:  Lindsay Fitzgerald, Senior Consultant, Astrix | Kristen Sauter, Sr. Director Global Regulatory Information Management & Digital Innovation, Takeda, Inc.

Presentation Abstract

As Sponsors continue to evolve and modernize their Regulatory Information Management (RIM) capabilities, it requires an evolution of the supporting business organization to exploit the value of modern RIM.

This session will explore the current state of RIM in the market, what business capabilities are required to support the modern RIM technology and broader Regulatory organizations’ use of it, as well as the business processes and governance required to “feed the beast.”

We will present different business models for RIM, and outline the pros and cons of each.

Featured Topics include:

• Understand how organizations are evolving and maturing in the strive for world-class RIM capabilities.
• What business capabilities are required to support the broader Regulatory organization?
• What operating models make the most sense: COE, full centralized capability, or a mix?

About Astrix

Astrix is the unrivaled market-leader in creating & delivering innovative strategies, solutions, and people to the life science community.  Through world class people, process, and technology, Astrix works with clients to fundamentally improve business & scientific outcomes and the quality of life everywhere. Founded by scientists to solve the unique challenges of the life science community, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across
their organizations.