2nd Floor

Chair(s)
Katarina Ilic / Francesco Salvo

ADR: from definitions to causality assessment Ushma Mehta
PV in an evolving environment: challenges and opportunities Francesco Salvo

9:45 - 10:15 Break
Quality of research in Pharmacovigilance Charles Khouri
Safety in Clinical Trials and Post-marketing Setting Katarina Ilic
PV Systems and Regulatory Expectations Tina Bostic

Panel Discussion
Ushma Mehta, Francesco Salvo, Charles Khouri, Katarina Ilic, Tina Bostic, Natália Kalousová Kocánková, John Caminis

Chair
Robert Platt

An overview of RWE Robert Platt
Regulatory perspective of RWE Luis Pinheiro

9:45 - 10:15 Break
Signal assessment using real world evidence from administrative healthcare databases Marco Tuccori
RWE in pharmacoepidemiology/signal refinement Gianluca Trifiro

We invite for lunch to all participants registered to PC1, PC2, PC3 and PC4.

Chair
Mónica Tarapués

Approaches for Signal Detection and Assessment: Industry Insights Salman Afsar, BMS
Approaches for Signal Detection and Assessment: FDA Insights Lisa Wolf, FDA
New methodologies in signal detection and assessment: EMA perspective Luis Pinheiro, EMA
14:45-15:15 Break
Approaches for signal detection and assessment using global pharmacovigilance data Alem Zekarias, UMC
Round table and final remarks Mónica Tarapués

Chair(s)
Monica Munoz

Safety reporting and E2D updates for improved pharmacovigilance Monica Munoz
Evolution of risk management and its intersection with signal management Alison Cave (MHRA)
14:45 - 15:15 Break
Regulatory landscapes and perspectives on pharmacovigilance in low- and middle-income countries Alex Dodoo
Communication strategies in pharmacovigilance amid misinformation and patient expectations Kelly Robinson