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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)
ICSR and Other Data Sources
Mohamed Abdel Hady
Gilead Sciences , United Arab Emirates
Pharmacovigilance and Epidemiology Manager
Qualitative and Quantitative Improvements to Data Collection
Phil Tregunno
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Deputy Director - Patient Safety Monitoring
VigiBase and Signal detection and Analysis Support for the WHO PIDM
Monica Elisabet Plöen, RPh
CTC Clinical Trail Consultant AB, Sweden
Safety Officer & Medical Coder
Panel discussion with Q&A
Mohammed Ebrahim Fouda, PharmD, RPh
Saudi Food and Drug Authority (SFDA), Saudi Arabia
Head of Signal Detection Department