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Session 4: Signalling
Session Chair(s)
Shanthi Pal, DRSC, MPHARM
Group Lead, Medicines Safety, Safety & Vigilance, WHO, Switzerland
This session will explore the latest developments in signal detection activities and how the tools provided by different regulatory authorities and other data sources are used to support drug safety monitoring. The focus will be on sharing methods and tools to capture ADRs as well as challenges in the region to process and receive the data.
Speaker(s)
Mohamed Abdel Hady
Pharmacovigilance and Epidemiology Manager, Gilead Sciences , United Arab Emirates
ICSR and Other Data Sources
Phil Tregunno
Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Qualitative and Quantitative Improvements to Data Collection
Monica Elisabet Plöen, RPH
Safety Officer & Medical Coder, CTC Clinical Trail Consultant AB, Sweden
VigiBase and Signal detection and Analysis Support for the WHO PIDM
Mohammed Ebrahim Fouda, PHARMD, RPH
Head of Signal Detection Department, Saudi Food and Drug Authority (SFDA), Saudi Arabia
Panel discussion with Q&A
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