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Regulatory Submissions, Information, and Document Management Forum


Session 8 Track 2: Transforming Regulatory Information Management Through Innovation

    Session Chair(s)
      Venkatraman  Balasubramanian, PhD, MBA

      Venkatraman Balasubramanian, PhD, MBA

      • President and CEO
      • Cabeus, Inc., United States
    It is increasingly becoming clear that data is at the center of most decision-making, both in our personal lives and in enterprises. Within regulatory, over the past three decades, we have gone full circle from data to documents to knowledge and back to data. How can data-intensive regulatory business processes be supported by rich information management applications where expectations of ubiquity and better user experience are of utmost importance? What can enterprise implementations of systems learn from consumer applications such as Amazon? How can innovations such as structured authoring and artificial intelligence transform regulatory? What is the industry doing about taking an end-to-end view of regulatory information management (RIM)? This session will have a reputed panel of experts sharing their views on how the industry must innovate and transform to the next generation of capabilities.
    Learning Objective : Upon completion of this session, the participant should be able to:
    • Understand how regulatory is increasingly become data-centric at its core
    • Review how state-of-the art technologies and capabilities could transform RIM
    • Understand what the industry is doing to adopt a holistic approach to RIM
    Speaker(s)
      Matt  Neal, MA

      Information and Connection

      Matt Neal, MA

      • Senior Director, Product Management, Regulatory & Clinical Solutions
      • PAREXEL, United States
      Peter  Lassoff, PharmD

      Eliminating White Space in Managing Marketing Products

      Peter Lassoff, PharmD

      • Vice President and Head, Global Regulatory Affairs
      • IQVIA, United Kingdom
      Jim  Nichols

      DIA’s RIM Working Group: Its Mission, Vision, and Value to Industry

      Jim Nichols

      • Vice President
      • Cunesoft Inc., United States