Regulatory Submissions, Information, and Document Management Forum

Don’t miss the latest conversations in Regulatory Informatics, EDM, and ERS! Join your industry colleagues and regulatory thought leaders by registering for the RSIDM Forum.

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

Session Chair(s)

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)

Blue Sky IDMP-Compliant Process as Reference for Gap Analyses

Hans van Bruggen, MSc

CEO and Senior RA Consultant
Qdossier, Netherlands

Implementing IDMP Strategies for Iteration 1

Karen Harry

Director, Regulatory Information Management
Calyx, United Kingdom

Implementation of Structured Data

Remco Munnik

Associate Director
Iperion, Netherlands

Contact us

Registration Questions?

Send Email
1.888.257.6457

Preconference Short Courses

Regulatory Content and Submission Primer: Content from Authoring to Archive

Short Course 1: Regulatory Considerations for Blockchain in Clinical Research and Drug Development