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Session 4 Track 1: RIM as an Enabler for Interoperability and Transparency: Current Achievements in Industry and Agencies
Session Chair(s)
Dominique Lagrave, PharmD
Senior Vice President of Regulatory Innovation
Accumulus Synergy, United States
This session will outline industry, health agency and vendor perspectives on RIM enabling operational efficiency. Presenters will demonstrate real life challenges and pragmatic solutions they have already applied to their environments to bring about interoperability and transparency as opposed to a scratch-all and instate a "RIM solution" undertaking.
Learning Objective : Discuss how demands resulting from IDMP, XEVMPD, RPS and the like challenge industry, service providers, standardization and regulatory bodies. Demonstrate pragmatic approaches to RIM implementations and how all stakeholders need to work together. Outline risks and benefits.
Speaker(s)
Industry Perspective
Teresa Martins
Bayer U.S. LLC, United States
Senior Director, US Site Head Regulatory Submission Management
Interoperability Between Existing Regulatory Systems: Conceptual Challenges and Practical Solutions
Akira Yamaguchi, MBA
LORENZ Life Sciences Group, United States
Chief Technical Officer
Interoperability of Systems Within the Germany Agency
Harald Von Aschen
Federal Institute For Drugs and Medical Devices Bfarm, Germany
Enterprise Architect
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