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Regulatory Submissions, Information, and Document Management Forum

On Demand 2 Track 1: IDMP – to Iteration 1 and Beyond

Session Chair(s)

Jo English

Jo English

  • Vice President, Regulatory Information Management
  • Calyx, United Kingdom
IDMP and other structured data initiatives continue to challenge organizations; There is a pressing need to be ready for the end of 2022, when Centralized products become mandatory alongside existing XEVMPD reporting. As well as data gathering, and data enrichment opportunities and strategies other process changes could bring efficiencies. The panel will describe different approaches for IDMP readiness and the emerging global picture for structured data acceptance.
Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify and list the global picture of structured data initiatives and assess their impact on their organization
  • Define priorities for IDMP data enrichment
  • Assess the impact of simultaneous IDMP and xEVMPD submissions
  • Establish a comprehensive data reuse strategy
  • Build reliability of data by design

Speaker(s)

Hans van Bruggen, MSc

Blue Sky IDMP-Compliant Process as Reference for Gap Analyses

Hans van Bruggen, MSc

  • CEO and Senior RA Consultant
  • Qdossier, Netherlands
Karen Harry

Implementing IDMP Strategies for Iteration 1

Karen Harry

  • Director, Regulatory Information Management
  • Calyx, United Kingdom
Remco Munnik

Implementation of Structured Data

Remco Munnik

  • Associate Director
  • Iperion, Netherlands