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Regulatory Submissions, Information, and Document Management Forum


Session 9 Track 2: Driving Innovation in Regulatory Technology within Life Sciences

    Session Chair(s)
      Vikesh  Srivastava

      Vikesh Srivastava

      • Associate Director, Business Informatics Division, HPFB
      • Health Canada, Canada
    This session will cover digital innovation in regulatory information management technology, its impacts on the Life Sciences industry and a perspective for the future. In addition, we will discuss how regulatory interactions are expected to change, particularly considering recent advances in analytics, real-world evidence, machine learning, and mobile health, as well as the challenges this brings for both the industry and regulatory authorities. The discussion will speak to industry case studies.
    Learning Objective : At the conclusion of this session, participants should be able to:
    • Learn how industry and regulators approach data utility and standards to support the value chain
    • Understand how “data hygiene” is paramount in establishing true ROI in analytics
    • Evaluate whether innovation can enable more efficient decision-making utilizing data from other sources
    • Understand the current landscape and opportunities of regulatory technology
    Speaker(s)
      Vada  Perkins

      Lifecycle Data Management: Practical Application of Data Standards, Innovation, and Technology for Global Regulatory Convergence

      Vada Perkins

      • Regulatory Policy and Intelligence
      • Bayer Pharmaceuticals, United States
      Fiona  Maini, MS

      Navigating the Regulatory Landscape of Innovation and Technology

      Fiona Maini, MS

      • Director
      • Deloitte LLP, United Kingdom
      John  Kiser, MSc

      Q/A-Industry Perspective on Adoption of Data Standards and Technology

      John Kiser, MSc

      • Principal
      • Kiser Regulatory Services, United States