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Regulatory Submissions, Information, and Document Management Forum


Session 2 Track 2: Regulatory Analytics

Session Chair(s)

Venkatraman  Balasubramanian, PhD, MBA

Venkatraman Balasubramanian, PhD, MBA

  • Senior Vice President, Life Sciences
  • Orion Innovation, United States
During this session, we will introduce the topic of Regulatory Analytics and explore how rich strategic insights are possible with the vast amounts of data being collected as part of RIM and IDMP initiatives. With a panel of three speakers from industry and vendors, we will have a rich discussion with case studies on how organizations can leverage RIM and IDMP data to go beyond compliance and achieve operational excellence and strategic advantage.
Learning Objective : Participants will learn how to increase the effectiveness of Regulatory Information Management beyond the traditional medicinal product life cycle to gain business advantages from existing information via Analytics, allowing trend predictions based on facts rather than fiction.

Speaker(s)

Venkatraman  Balasubramanian, PhD, MBA

Regulatory Analytics: Strategic Insights Beyond Compliance and Efficiency

Venkatraman Balasubramanian, PhD, MBA

  • Senior Vice President, Life Sciences
  • Orion Innovation, United States
Olaf  Schoepke, PhD

Gaining Intelligence from Regulatory Information Management via Utilizing Medicinal Product Analytics

Olaf Schoepke, PhD

  • Vice President, Regulatory Solutions
  • Instem, United Kingdom
Thomas  Denaro

Regulatory Analytics: Asking the Right Questions to Yield Real and Sustainable Business Value

Thomas Denaro

  • Senior Business Analyst
  • Orion Innovation, United States