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The Importance of Data Management and CDISC/IDMP Data Standards for First Time Right Submissions
Session Chair(s)
Niels Leander, PHD
Partner - Life Sciences
Eraneos, Denmark
This session will discuss the data standards of CDISC and IDMP. Our focus will be on tools and methodologies for using the data standards for improving the speed and quality of submitting regulatory dossiers to the authorities. The session will discuss how documents and data can be aligned and how structures for be put in place for governing data through the submission process.
Learning Objective : • Participants will be introduced to regulatory data submissions such as IDMP • Participants will be acquainted with EMA’s IT strategy and the impact on data management and data governance in the industry • Participants will be introduced to data governance steps that are needed for managing IDMP efficiently
Speaker(s)
3 Ways that Data Governance is needed for getting IDMP right
Niels Leander, PHD
Eraneos, Denmark
Partner - Life Sciences
ADaM Specifications for Statistical Reporting: Making Documentation Almost Fun
Jean-Christophe Chiem, PHD
IDDI, Belgium
Senior Statistical Scientist
IDMP to Drive Data and Document Management for Supply Chain & Regulatory
Hans van Bruggen, MSC
Celegence, United States
Director of Regulatory Affairs