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Bethesda North Marriott Hotel and Conference Center

Feb 10, 2020 11:00 AM - Feb 12, 2020 2:15 PM

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

Regulatory Submissions, Information, and Document Management Forum

Session 6 Track 2: Put People and Data First to Make Your Process and Technology Work

Session Chair(s)

Danielle  Beaulieu, PhD

Danielle Beaulieu, PhD

Senior Director, Global Regulatory Business Capabilities

Bristol-Myers Squibb, United States

Data is key to RIM systems. Data is why people use RIM systems. Therefore when implementing a new RIM system, it is critical to start with the data and process in mind. Unless you thoroughly understand the data and why users need it, you will not know what you need to design, and critical aspects such as user acceptance/adoption and data quality will not be successful. Understanding people and business process is the first step to understanding how and what data needs to be maintained. Understanding multiple global legacy business processes and transforming these into simplified and harmonized processes with appropriate use of technology, and a clear governance process is critical to a successful implementation. Understanding when other parts of the organization will need to use regulatory information to enable their processes, will impact both data and processes, and this is when the use of master data management becomes critical. This session will bring together 3 speakers who will share their experiences, successes and failures in implementing systems to fully support the future state of regulatory data, to enable data integrity and achieve business excellence.

Learning Objective :

At the conclusion of this session, participants should be able to:

  • Create an organization for MDM to help build RIM data integrity
  • Drive data integrity as one of the critical components of business excellence
  • Identify how to build a data framework to ensure regulatory systems can be trusted
  • Outline how data is one of the most critical factors in a successful RIM launch


Jamie  O'Keefe

Data’s Great Until it’s Not – The Criticality of Governance and Change Management in Regulated Systems

Jamie O'Keefe

Astrix, United States

Head, Clinical & Regulatory Consulting

Robert  Baldry

New Technology is Great, But What About the Data?

Robert Baldry

Genpact, United States

Digital and Data Lead, Regulatory Affairs

Teginder  Singh, MPharm

RIM IDMP MDM Data Integrity Approaches

Teginder Singh, MPharm

Johnson & Johnson, United States

VP, Regulatory Affairs

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