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Session 8 Track 2: Perspectives on IDMP
Session Chair(s)
Danielle Beaulieu, PHD
Senior Director, Global Regulatory Business Capabilities, Bristol-Myers Squibb, United States
It is well known that IDMP is more than a regulatory problem. This session will focus on two benefits of implementing this standard, no matter the size of your enterprise: 1) leveraging your IDMP program to implement enterprise wide data governance and standards, and 2) leveraging your newly defined IDMP process to ensure your enterprise is moving toward structured data. We will cover the thought process needed to be successful, potential interim solutions you might need to consider, how to include automation (or not!), planning your process to cover the target operating model, gather the data at the beginning instead of the end, how to handle guidance changes and their impact to what you have already done, and what your deliverables should be to complete the project.
Learning Objective : At the conclusion of this session, participants should be able to:
- Describe small company requirements and level of effort for IDMP implementation
- Assess near and long-term implementation options
- Define a forward looking data driven process
- Describe tools that can be leveraged to deliver process
Speaker(s)
Scott Cleve
Vice President Regulatory Labeling, Operations and Writing, Daiichi Sankyo, United States
A Small Biotech/Small Company Perspective on IDMP Assessment and Implementation
Thomas Denaro
Senior Business Analyst, Orion Innovation, United States
Case Study: Practical Approach to IDMP Implementation for Regulatory Teams
Isabel Esteve Garcia, MSC
Associate Director, Global Regulatory Business Capabilities Strategist, Bristol-Myers Squibb, United States
Case Study: Practical Approach to IDMP Implementation for Regulatory Teams
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