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The Data Scientist’s Handbook: ‘Good Science’ Principles in Non-Interventional Studies
Session Chair(s)
Virginia Acha, PhD, MSc
AVP, Global Regulatory Policy
Merck Sharpe & Dohme LLC , United States
Reflecting on recent efforts to define good science principles for non-interventional studies, this forum offers an introduction to the principles and practices that can enhance trust and the challenges that remain to broader acceptance.
Learning Objective : Describe the essential and contextual challenges for the health data scientist in the design, conduct, and use of data from non-interventional studies, including the use of real-world data; Define ‘good science’ principles to underpin robust and reliable study design and analysis that engenders trust and acceptance amongst healthcare decision makers, including for regulatory decision-making.
Speaker(s)
Panelist
Bart Barefoot, JD
GSK, United Kingdom
Head, Europe Regulatory Policy
Panelist
Patrice Verpillat, DrMed, MD, PhD, MPH
European Medicines Agency, Netherlands
Head of Real World Evidence
Panelist
Catherine Cohet, PhD
European Medicines Agency, Netherlands
Senior Pharmacoepidemiologist, Data Analytics and Methods Task Force
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