Regulatory Submissions, Information, and Document Management Forum

This session will focus on several aspects related to data unification, data integration, data governance, and data quality monitoring through emerging data standards such as IDMP:

• We will start with a case study of a large OTC products company defining their core product data by adopting ISO IDMP as a global data framework to be used across regions and functions and to unify data across disconnected systems using standardized vocabularies. This core product data can be leveraged across multiple functions and systems to allow end-to-end traceability from R&D to sales
• We will see how cloud technologies are being leveraged at another large pharmaceutical company to support emerging requirements of IDMP, PQCMC, and structured data submissions. This is accomplished through data integration, data governance, and data quality monitoring approaches that result in unambiguous data. Techniques such as data quality scorecards and data quality tools will be reviewed
• We will explore how organizations can get ready to meet IDMP requirements through the assessment of data sources and data quality through the use of intelligent data mapping and reporting techniques. Automated data quality solutions can enable efficient data mapping, identification of data gaps in IT-systems and documents, and provide reporting dashboards for data quality issues and corrections. These outputs can then be utilized to bridge process gaps and develop an implementation strategy with high degree of confidence regarding data quality