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Session 10 Track 2: Cross-Industry Collaboration and Cross-Functional Integration of Data
Session Chair(s)
Venkatraman Balasubramanian, PhD, MBA
SVP and Global Head, Industry Solutions - Healthcare and Life Sciences
Orion Innovation, United States
There is increasing demand for sharing of regulatory data and also integrating with various aspects of the drug development value chain. This session will address three major, emerging topics, namely:
- Collaboration across the industry with the creation of a platform for Health Authorities to collaboratively review submissions. This presentation will focus on the initial Accumulus use case, derived requirements and enabling technologies, and will highlight challenges and opportunities in security, compliance, and data privacy on this industry-first collaboration platform
- Use of Reference Data Management (RDM) as a powerful approach to integrate data without the challenges that arise from extraction, transformation, and loading (ETL) of data. RDM enables automatically connecting data in one system to similar but not necessarily identical data in other systems, through the use of semantic equivalents.
- Integration of regulatory data with manufacturing data for better impact analysis and decision making. This presentation will focus on practical approaches to integrate Regulatory Information Management (RIM) data with Quality Management System (QMS) data to bring in efficiencies across two functional areas.
Learning Objective : At the conclusion of this session, participants should be able to:
- Cross-industry collaboration through the Accumulus platform for review of submissions
- Explore the use of Reference Data Management to support semantic interoperability
- Understand practical approaches to integrate/link regulatory data with manufacturing data
Speaker(s)
Introduction to Accumulus: Building a First, Real-time Cloud SaaS Submission Review Collaboration Platform Shared Across HA’s and Sponsor Organizations
Dominique Lagrave, PharmD
Accumulus Synergy, United States
Senior Vice President of Regulatory Innovation
Reference Data Management for Semantic Interoperability and Data Sharing
Hans van Bruggen, MSc
Qdossier, a Celegence Company, Netherlands
CSO
Linking Regulatory Data with Manufacturing Data for Better Impact Assessments
Raghu Nandan
Bristol-Myers Squibb, United States
Director, Global Delivery, R&D and Quality Domain Architect
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