戻る Agenda
Session 4: True Adverse Reaction or Not: That’s the Question
Session Chair(s)
Magnus Ysander, MD
EU & UK QPPV & Head Pharmacovigilance Excellence
AstraZeneca, Sweden
Katarzyna Swiderek, MPharm, RPh
Director, Safety Evaluation Risk Management (SERM)
GlaxoSmithKline, Poland
Determining what are the true side effects of a medicinal product is the very core of patient safety work. Although the basic components of such assessments are common, the specific approaches may differ between practitioners in different parts of the pharmacovigilance network. In this session, representatives from industry and regulators, together with other experts, will present and discuss the broad aspects of causality assessment at group level, including; principles, thresholds, methodology and tools. Challenges and opportunities will also be covered as well as the role of the QPPV.
Speaker(s)
Big Pharma Perspective
Magnus Ysander, MD
AstraZeneca, Sweden
EU & UK QPPV & Head Pharmacovigilance Excellence
Regulator’s Perspective
Irina Caplanusi, MD, MSc
European Medicines Agency, Netherlands
Signal Management Lead, Pharmacovigilance Department
Epidemiologist Perspective
Alejandro Arana
RTI Health Solutions, Spain
Senior Director of Epidemiology