DIA RMP Forum

Overview

As regulatory expectations for Risk Management Plans (RMPs) continue to evolve worldwide, the integration of real-world data (RWD), post-authorization safety studies (PASS), and evidence-based safety monitoring is becoming increasingly important. The DIA RMP Forum brings together regulators, industry leaders, and pharmacovigilance experts from Europe, Japan, and Korea to discuss current regulatory requirements, implementation challenges, and future strategies for RMP innovation.

Participants will gain insights into EMA and PMDA perspectives on PASS and RMP implementation, learn from industry case studies, and explore how RWD can support pharmacovigilance activities and regulatory decision-making. The forum will also highlight emerging global trends, including ICH M14 and the growing role of real-world evidence in risk management.

Through expert presentations and a multi-stakeholder panel discussion, attendees will explore practical approaches to advancing RMP practices in Korea and preparing for the future of patient-centered, evidence-driven risk management.