Regulatory Submissions, Information, and Document Management Forum

戻る Agenda

Session 8 Track 1: Establishing Data Quality & Data Governance Frameworks

Session Chair(s)

Kristen Sauter, MBA

Senior Director, Head, Global RIM, Analytics & Digital Innovation

Takeda Pharmaceuticals, United States

As industry is advancing the approaches to regulatory information management and the systems that contain their data, there is a heightened focus on the need for comprehensive data governance frameworks and sustainable data quality programs. This session will address:

Data Quality: The degree to which data in an organization meets the needs of the users and expectations of consumers is often measured by accuracy, validity, completeness, and consistency. And, defining and implementing a comprehensive approach to data quality is a critical component of a success for any organizations RIM program
Data Governance: Given the increased complexity of the and demand for transparency, managing registrations and sharing regulatory data is critical and necessitates the need for organizations to establish robust approaches to data governance

Learning Objective : At the conclusion of this session, participants should be able to:
Design and implement a comprehensive Data Quality approach

Define an approach to building out a RIMS Data Governance Program

Understand

Speaker(s)

Data Quality Sustainability - Improving Data Governance

Steve Gens, MS

Gens & Associates Inc., United States

Managing Partner

Implementing a Data Governance Program for Your RIMS

Samuel Thompson

NNIT, United States

Managing Consultant