Skip to main content
2024 ISPE Annual Meeting Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back
Evaluation

Workshop/Symposium

Session: Symposia & Workshops: Session 2

Advancing Drug Safety Signal Management through Multimodal Approaches in Networking

Monday, August 26, 2024
3:30 PM – 5:00 PM CEST
Location: Auditorium
Background: With the emergence of diverse data sources and novel methodologies, the paramount task in pharmacovigilance lies in applying multimodal approaches to integrate safety information through networks and understanding its potential impact on decision-making.

Objectives: 1) To illuminate the value of multimodal approaches in managing drug safety signals. 2) To facilitate the exchange of experiences and best practices in constructing multimodal signal management models via distributed networks. 3) To discuss the implementation of multimodal approaches in various phases of signal management, including detection, validation, prioritization, and evaluation. This symposium is aimed at researchers interested in pharmacovigilance and drug safety monitoring.

Description: The event will commence with Prof. Edward Lai overseeing the symposium, providing an introductory overview and presenting the speakers (4 min). Ms. Miyuki Hsieh will then address the challenges brought forth by the emergence of diverse data sources in pharmacovigilance (8 min). Following this, Dr. Darmendra Ramcharran will discuss the construction and application of Multimodal Signal Management across different signal management phases (12 min). Insights into applying multimodal approaches in signal detection, validation/prioritization, and evaluation through various networks will be shared by Dr. Judith C Maro, Mr. Oskar Gauffin, and Dr. Ju-Young Shin, representing Sentinel (US), EHDEN (European region), and AsPEN (Asia-Pacific region) networks, respectively (12 min for each). The symposium will conclude with a panel discussion (30 min) led by Prof. Anton Pottegård, Ms. Weny Huang, and Dr. Shih-Chieh Shao, representing academic, regulatory, and clinical perspectives, respectively. The session will focus on key aspects of signal detection, validation, prioritization, and transition to decision-making. This discussion will explore challenges and potential solutions in applying multimodal approaches within distributed networks, promoting an interactive platform for knowledge sharing and audience engagement in the field of drug safety signal management.