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Advanced Analytics, Cross-Industry Collaboration, and Data Sharing to Change the Paradigm in Clinical Quality
Session Chair(s)
Timothe Menard, PHARMD, MSC
Global Head, Quality Excellence Digital | Bioethics Ambassador
F. Hoffmann-La Roche Ltd, Switzerland
In this session, we will share selected use cases on our collaboration framework. We will also engage with the audience on how we (industry, regulators, patients) can all contribute to a change in paradigm for QA, i.e. where advanced analytics can help detecting and mitigating issues faster, and ultimately accelerate approval and patient access of innovative drugs.
Learning Objective : Examine how advanced analytics are utilized throughout the development lifecycle and how this could lead to a paradigm shift in clinical quality; Describe how the inter company quality analytics (IMPALA) group members collaborate to accelerate the development of advanced analytics for clinical quality; Identify how cross-company data sharing can foster development and validation of advanced analytics.
Speaker(s)
Industry Update
Jennifer Emerson, PHD, MPH, RN, PMP
Boehringer Ingelheim, Germany
Head Quality Analytics & Risk Management
Industry Update
David Donohue, MBA
GlaxoSmithKline, United States
Head, Quality Systems and Data Analytics
Industry Update
Robert Studt
Janssen, United States
Head of Quality Analytics, BioResearch Quality and Compliance