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Session 6 Track 1 - IDMP Part 2: Are you ready for IDMP? The Business Perspective
Session Chair(s)
Hans van Bruggen, MSc
CSO
Qdossier, a Celegence Company, Netherlands
This session picks up from the previous IDMP background session and concentrates on integrating business processes and the challenges associated with it. This will be followed by a panel discussion. Topics include:
• Provide a conceptual approach on how to get ready to meet IDMP requirements. Companies that had to comply with XEVMPD reporting requirements are well aware of the challenges collecting, curing and submitting required cross functional data. Even though IDMP implementation guidelines have not been published and software solutions don’t exist yet, preparations for IDMP should not be postponed.
• Focus on understanding how cross-functional input is required to implement IDMP and discuss how to get ready for such an implementation, especially, around maintaining internal controlled vocabularies to support IDMP, RIM and beyond.• Provide insight to a company’s challenges for IDMP readiness.
Speaker(s)
IDMP and Integrating Business Processes
Hans van Bruggen, MSc
Qdossier, a Celegence Company, Netherlands
CSO
IDMP: A Sponsor’s Perspective
Peter Terbeek, MBA
United States
Senior Director, Regulatory Operations
Panel discussion also includes:
Joel Finkle
Retired, United States
Industry Expert
Panel discussion also includes:
Venkatraman Balasubramanian, PhD, MBA
Orion Innovation, United States
SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
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