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Session 9 Track 1: Regulatory 3.0 - A Data Driven Perspective
Session Chair(s)
Jake Doran
Head of Digital
Lykos Therapeutics, United States
In this session, we will present a case study that focuses on building a Data Governance framework from the ground up and utilizing the IDMP standard as a backbone. The flexible design of this Data Governance framework enables the organization to flex and pivot in response to the constantly changing regulatory requirements (e.g., IDMP requirements) without disrupting the foundational components of their day-to-day business. This session will explore how a data driven approach can unlock information, data, and digital tools to realize a Regulatory 3.0 operating environment.
Learning Objective : At the conclusion of this session, participants should be able to:
- Ability to define data driven strategies and activities and assess the impact to establishing these activities
- Assess the change management communication and activities to support a data unification program in your organization
- Compare and contrast data initiatives based on sponsor examples and case studies
Speaker(s)
Regulatory 3.0 - A Data Driven Perspective
Scott Cleve
Daiichi Sankyo, United States
Vice President Regulatory Operations Information and Compliance
Speaker
Frits Stulp, MSc
Iperion Life Sciences Consultancy, Netherlands
Managing Director
Speaker
Matt Neal, MA
Atara Biotherapuetics, United States
Senior Director, Regulatory Affairs Operations
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