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Bethesda North Marriott Hotel and Conference Center

Feb 14, 2022 8:30 AM - Feb 16, 2022 2:15 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

Regulatory Submissions, Information, and Document Management Forum

Session 8 Track 2: Perspectives on IDMP

Session Chair(s)

Danielle  Beaulieu, PhD

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

A Small Biotech/Small Company Perspective on IDMP Assessment and Implementation

Scott Cleve

Daiichi Sankyo, United States

Vice President Regulatory Labeling, Operations and Writing

Thomas  Denaro

Case Study: Practical Approach to IDMP Implementation for Regulatory Teams

Thomas Denaro

Orion Innovation, United States

Senior Business Analyst

Isabel  Esteve Garcia, MSc

Case Study: Practical Approach to IDMP Implementation for Regulatory Teams

Isabel Esteve Garcia, MSc

Bristol-Myers Squibb, United States

Associate Director, Global Regulatory Business Capabilities Strategist

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