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.
Please note that lunch and parking vouchers will not be provided during the event.
Program Committee
-
Ju-Young Shin, PhD Professor
Sungkyunkwan University, Korea, Republic of -
Yil-Seob Lee, MD, PhD Professor
CHA Bundang Medical Center , Korea, Republic of -
Min-Jung Lim, MPharm, RPh CEO & Senior Pharmacovigilance Consultant
MediSafe, Pharmacovigilance Services, Korea, Republic of -
Hyungjin Jung, MD, MBA Senior Medical Director
Lundbeck Korea, Korea, Republic of -
So Hee Kim, PhD Director / Ministry of Food and Drug Safety
National Institute of Food and Drug Safety Evaluation (NIFDS), Korea, Republic of -
Bonggi Kim, PhD Director
Korea Institute of Drug Safety and Risk Management, Korea, Republic of -
HyeYoung Kim Medical Information & Pharmacoviglance
Chong Kun Dang Pharm, Korea, Republic of -
Namkyong Choi Associate Professor
Ewha Womans University, Korea, Republic of -
Young Joo Park, PhD, MPH VP, Korea, Singapore, and Southeast Asia
DIA, Korea, Republic of
Have an account?