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

Session Chair(s)

Venkatraman  Balasubramanian, PhD, MBA

Venkatraman Balasubramanian, PhD, MBA

  • Senior Vice President, 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

Speaker(s)

Brian  Williams

Enabling Regulatory Strategy Teams through Technology and Automation

Brian Williams

  • Managing Director, Life Sciences
  • KPMG, United States
Daniel  Smith

Increase Regulatory Efficiencies through Analytics

Daniel Smith

  • Business Analyst, RIM
  • Calyx, United Kingdom
Ravi  Krishnamurthy, MBA

An Architectural Framework for Regulatory Analytics and Impact Analysis

Ravi Krishnamurthy, MBA

  • Senior Vice President, Life Sciences
  • Orion Business Innovation, United States