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Feb 08, 2021 10:00 AM - Feb 10, 2021 4:30 PM

(Eastern Standard Time)

Regulatory Submissions, Information, and Document Management Forum

Session 9 Track 2: Enabling R&D Strategy through Automation and Analytics

Session Chair(s)

Venkatraman  Balasubramanian, PhD, MBA

Venkatraman Balasubramanian, PhD, MBA

SVP and Global Head, Industry Solutions - Healthcare and Life Sciences

Orion Innovation, United States

Several enabling technologies have evolved over the years to support the regulatory operations function but not too many to support Regulatory Strategists. It is time to look at how digital transformation can enable regulatory strategy and regulatory intelligence activities to drive decision making, to streamline analysis, and to improve global coordination. Effective decision making can be supported by the exploitation of information present in RIM systems which requires harnessing quality data and transforming data into intelligence using analytics. Better analytics is possible only through the integration of data across siloed systems and processes not only within Regulatory but also across adjoining functional areas such as Clinical, Safety, Manufacturing, Quality, etc. During this session, we will see presenters making the connection between digital transformation to enable regulatory strategy activities with quality data and analytics followed by a framework on how analytics can be accomplished using existing systems with appropriate examples.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Identify practical ideas for enabling Regulatory Strategy and Regulatory Intelligence activities through emerging technology and analytics tools
  • Transform data into intelligence through analytics capabilities
  • Understand the use of an analytics platform for regulatory and R&D


Brian  Williams

Enabling Regulatory Strategy Teams through Technology and Automation

Brian Williams

KPMG, United States

Advisory Managing Director, Life Sciences

Daniel  Smith

Increase Regulatory Efficiencies through Analytics

Daniel Smith

Calyx, United Kingdom

Senior Regulatory Information Management Consultant

Ravi  Krishnamurthy, MBA

An Architectural Framework for Regulatory Analytics and Impact Analysis

Ravi Krishnamurthy, MBA

Orion Business Innovation, United States

Senior Vice President, Life Sciences

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