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Thursday, July 1 • 10:00am - 11:00am
#408 SL: The Data Scientist’s Handbook: ‘Good Science’ Principles in Non-Interventional Studies

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-637-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.

Chair

Virginia Acha, PhD, MSc

Speaker

Panelist
Bart Barefoot, JD

Panelist
Patrice Verpillat, DrMed, MD, PhD, MPH

Panelist
Catherine Cohet, PhD



Speakers
avatar for Virginia Acha

Virginia Acha

Global Lead, Global Regulatory Policy, MSD, United Kingdom
Virginia (Ginny) has worked in industry and academia throughout her career, combining interests in science policy research and innovation performance within and across organizations. She recently joined MSD to lead regulatory policy efforts for innovation that will lead to better... Read More →
avatar for Bart Barefoot

Bart Barefoot

Senior Director, European Regulatory Policy, GlaxoSmithKline, United Kingdom
Bart Barefoot, JD, is Senior Director of European Regulatory Policy at GlaxoSmithKline. He formerly served as GSK's global head of RWE policy development and engagement, where he led the company's efforts to advance the appropriate use of RWE in health care decision-making. He served... Read More →
avatar for Patrice Verpillat

Patrice Verpillat

Head of Global Epidemiology and ISPE RWE Task Force, Merck Healthcare KGaA, Germany
Dr Verpillat has started in the pharma industry in 2003 (H. Lundbeck A/S, Sanofi-Aventis Group, Boehringer Ingelheim GmbH, and currently at Merck KGaA/EMD Serono), in departments such as Epidemiology, Pharmacovigilance, Market Access, always dealing with real-world data and non-interventional... Read More →
avatar for Catherine Cohet

Catherine Cohet

Pharmacoepidemiology/RWE Expert, Data Analytics and Methods Task Force, European Medicines Agency, Netherlands
Catherine has joined the EMA in 2020, after several years holding various pharmacoepidemiology positions in the pharmaceutical industry (GlaxoSmithKline, Sanofi Pasteur MSD). She has extensive experience generating real-world evidence across all phases of medicines development, including... Read More →


Thursday July 1, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  03: Data-Data Standards, Forum