Session 10 Track 2: Cross-Industry Collaboration and Cross-Functional Integration of Data

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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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