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Session 9 Track 2: Driving Innovation in Regulatory Technology within Life Sciences
Session Chair(s)
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)
Lifecycle Data Management: Practical Application of Data Standards, Innovation, and Technology for Global Regulatory Convergence
Vada A. Perkins, DrSc, MSc
Boehringer Ingelheim, United States
Vice President, Global Head of Regulatory Intelligence & Policy
Navigating the Regulatory Landscape of Innovation and Technology
Fiona Maini, MS
Medidata a Dassault Systèmes Company, United Kingdom
Principal Global Compliance and Strategy Principal
Q/A-Industry Perspective on Adoption of Data Standards and Technology
John Kiser, MSc
Kiser Regulatory Services, United States
Principal