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Innovations in Signal Detection: Advancing Safety Signals with the READUS-PV Guidelines and Regulatory Updates
Session Chair(s)
Judy Shin, PhD
Professor
School of Pharmacy, Sungkyunkwan University, Korea, Republic of
This session will introduce the latest efforts to enhance the quality of safety signal generation from government, industry, and academia (e.g., recommendations, regulatory frameworks, case examples) and will conclude with a panel discussion.
Learning Objective : Explain the latest recommendations for reporting the results of safety signal generation (transparency, completeness) and relevant case example; Examine case examples to enhance the quality of safety signal generation in industry and academia: task process and methodologies; Discuss perspectives from government, industry, and academia to enhance the quality of safety signal generation.
Speaker(s)
Shaping the Future of Signal Detection: Industry Trends and Evolving Practices in Pharmacovigilance
Andrew Bate, PhD, MA
GlaxoSmithKline, United Kingdom
Vice President, Head of Safety Innovation and Analytics
Pharmacovigilance and Signal Detection in Korea Institute Drug Safety and Risk Management
HYUN JOO JUNG, PharmD, PhD
Korea Institute of Drug Safety & Risk Management, Korea, Republic of
Pharmacovigilance Innovations in Signal Detection: Bridging Safety Signals and Regulatory Decisions in Taiwan
Wei-I Huang, MS, RPh
Taiwan Drug Relief Foundation, Taiwan
Director, Division of Drug Safety
A New Standard in Signal Detection: Reporting and Analyzing Drug Safety Signals with the READUS-PV Guidelines and beyond
Michele Fusaroli, DrMed, PhD
Uppsala Monitoring Centre, Sweden
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