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DIA EUROPE 2021

The Importance of Data Management and CDISC/IDMP Data Standards for First Time Right Submissions

Session Chair(s)

Niels Buch Leander, PhD

Niels Buch Leander, PhD

  • Associate Vice President, Global Head of Regulatory Affairs
  • NNIT, 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 : Get a better understanding how IDMP databases can help with document management in Module 1 and 3. Get a better understanding on how lean and consistent authoring can ease review and approval for internal reveiwers and external regulators

Speaker(s)

Niels Buch Leander, PhD

3 Ways that Data Governance is needed for getting IDMP right

Niels Buch Leander, PhD

  • Associate Vice President, Global Head of Regulatory Affairs
  • NNIT, Denmark
Jean-Christophe Chiem, PhD

ADaM Specifications for Statistical Reporting: Making Documentation Almost Fun

Jean-Christophe Chiem, PhD

  • Senior Statistical Scientist
  • IDDI, Belgium
Hans van Bruggen, MSc

IDMP to Drive Data and Document Management for Supply Chain & Regulatory

Hans van Bruggen, MSc

  • CSO
  • Qdossier, a Celegence Company, Netherlands