戻る Agenda
Session 6 Track 2: Put People and Data First to Make Your Process and Technology Work
Session Chair(s)
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
Speaker(s)
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
New Technology is Great, But What About the Data?
Robert Baldry
Genpact, United States
Digital and Data Lead, Regulatory Affairs
![Teginder Singh, MPharm](/_Images/member/Generic_Image_Missing-Profile.jpg)
RIM IDMP MDM Data Integrity Approaches
Teginder Singh, MPharm
Johnson & Johnson, United States
VP, Regulatory Affairs