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DEVELOPMENT OF PHARMACOVIGILANCE METHODOLOGY
Session Chair(s)
Monika Pietrek, MD, PhD, MSc
Managing Director and Senior Consultant
Pietrek Associates GmbH, Germany
Behavioural assessment of Risk Management Tools
Learning Objective : Demonstrate the use of formal and structured benefit-risk methodologies in the post-marketing setting.
Speaker(s)
Benefit-Risk Assessment in a Post Market Setting: A case study integrating real-life experience into benefit-risk methodology
Christine Hallgreen, DrSc, PhD
University of Copenhagen, Denmark
Associate Professor
PROTECT the Patient – signal detection in clinical trial data
Andreas Brueckner
Novartis Pharma AG, Switzerland
Quantitative Safety Scientist
Behavioural assessment of Risk Management Tools
Swapu Banerjee, MD, MBA, MSc, FRCP
Pope Woodhead & Associates Ltd, United Kingdom
Deputy Managing Director
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