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Innovations in Signal Detection: Advancing Safety Signals with the READUS-PV Guidelines and Regulatory Updates
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-25-551-L04-P; CME 1.00; RN 1.00

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 Objectives

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.

Chair

Judy Shin, PhD

Speaker

Shaping the Future of Signal Detection: Industry Trends and Evolving Practices in Pharmacovigilance
Andrew Bate, PhD, MA

Pharmacovigilance and Signal Detection in Korea Institute Drug Safety and Risk Management
HYUN JOO JUNG, PharmD, PhD

Pharmacovigilance Innovations in Signal Detection: Bridging Safety Signals and Regulatory Decisions in Taiwan
Wei-I Huang, MS, RPh

A New Standard in Signal Detection: Reporting and Analyzing Drug Safety Signals with the READUS-PV Guidelines and beyond
Michele Fusaroli, DrMed, PhD


Speakers
avatar for Andrew Bate

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
avatar for Michele Fusaroli

Michele Fusaroli

Uppsala Monitoring Centre, Sweden
Michele Fusaroli, MD, PhD, serves as a Senior Pharmacovigilance Scientist at the Uppsala Monitoring Centre's Research Department. He steered the READUS_PV group, which focused on establishing reporting guidelines for disproportionality analysis. Fusaroli Michele has implemented innovative... Read More →
avatar for Wei-I Huang

Wei-I Huang

Director, Division of Drug Safety, Taiwan Drug Relief Foundation, Taiwan
Ms. Wei-I Huang is a clinical pharmacist specializing in pharmacovigilance and regulatory pharmacoepidemiology. Her expertise includes drug safety signal detection, risk assessment, and regulatory compliance. As Director of the Taiwan National ADR Reporting Center, operated by the... Read More →
HJ

HYUN JOO JUNG

Departiment of Drug Safty Information, Korea Institute of Drug Safety & Risk Management, Korea, Republic of
I am currently working as the director of the office of drug safety information of department of drug safety information in Korea Institute of Drug Safety & Risk Management. Based on the Pharmaceutical Affairs Act of Korea, we collect, analyze, assess and management drug safety information... Read More →
avatar for Judy Shin

Judy Shin

Professor, School of Pharmacy, Sungkyunkwan University, Korea, Republic of
Dr. Ju-Young Shin is the Chair Professor of Biohealth Regulatory Science at the School of Pharmacy, Sungkyunkwan University (SKKU). She serves as an associate editor for SCIE journals such as Pharmacoepidemiology and Drug Safety and Epidemiology and Health. She earned her B.S. in... Read More →
Tuesday June 17, 2025 8:30am - 9:30am EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

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