Regulatory Submissions, Information, and Document Management Forum

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

Session Chair(s)

Jo English

Chief Strategy Officer

Ennov, 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)

Blue Sky IDMP-Compliant Process as Reference for Gap Analyses

Hans van Bruggen, MSc

Qdossier, a Celegence Company, Netherlands

CSO

Implementing IDMP Strategies for Iteration 1

Karen Harry

Viatris, United Kingdom

Senior Manager Regulatory Initiatives

Implementation of Structured Data

Remco Munnik

IRISS Forum, Spain

President

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