Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Bethesda North Marriott Hotel and Conference Center

Feb 12, 2024 8:00 AM - Feb 14, 2024 2:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Don't miss the latest trends, innovations, and best practices in regulatory submissions, information, and document management (RSIDM)!

Session 7 Track 4: Achieving Operational Excellence through Master Data and Optimizing Digital Processes

Session Chair(s)

Dominik  Gigli

Dominik Gigli

Management Consultant

Main5 GmbH & Co. KGaA, Germany

In today’s current state, data and many procedures are bound by functional silos, and while the data collected and the existing processes might be considered optimized within their individual domains, to truly achieve breakthrough improvement, optimization of data and processes must be achieved across the enterprise and beyond these individual domains. Many of these business needs already exist, including the need to measure time from safety signal to implementation of an updated label, or having the ability to run reports specific to combining regulatory authorization and marketing information.

Key to solving these challenges is leveraging standards (like the RIM Reference Model, open APIs) that allow for more consistent and seamless flows of information in and around the ‘regulatory Information' that sits at the middle of the equation. That along with being able to define business processes and & information capture needs in a repeatable, consistent and automated fashion will support operational excellence as well as greater information traceability.

Working to break down silos and having data flow across many domains will lead to business value including seeing measurable improvement across the end-to-end submission process, implementation of manufacturing improvements by implementing changes closer to the time of health authority (HA) approval, and drive efficiency with release of product to patients. In this session, we will discuss how establishing a road map for creating rules for master data, empowering Business Process Owners to work cross-functionally and connecting authoritative sources for information across the enterprise will eliminate unnecessary hand-offs, will reduce cycle times, and will improve compliance to regulations.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify inputs to building a vision for stitching data together across domains at their respective company
  • Illustrate how requirements like IDMP can set the foundation to working smarter internally
  • Explain how, with cross-functional data better connected, driving measurable improvement within end-to-end processes specific to compliance, cycle times, and all with fewer hand offs is possible


Eric  Cardwell, MBA

Measurable Improvement with Integrated Information

Eric Cardwell, MBA

AbbVie, United States

Director, Regulatory Information Management

James  Nichols

Importance of Leveraging Data Standards, RIM Reference Models, and Open APIs

James Nichols

Lorenz Life Sciences Group, United States

Director of Sales & Account Management

Vanni  Carapetian, MPH

Stitching Data Together, What Does that Look Like?

Vanni Carapetian, MPH

Genentech, A Member of the Roche Group, United States

Director, Regulatory Data

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.