[Brief Introduction of Seminar]
Real-world data (RWD) are increasingly being used throughout the drug development lifecycle, from characterizing disease burden and unmet medical needs to optimizing target populations and clinical trial design, constructing external control arms, supporting regulatory decision-making, evaluating post-marketing safety and effectiveness, and informing indication expansion. From this lifecycle perspective, this lecture will examine how important identified risks, important potential risks, and missing information specified in a risk management plan (RMP) can be translated into focused research questions and implemented through non-interventional study protocols suitable for regulatory use. It will also present a case study in which symptom-based adverse events that are difficult to capture using structured data alone are identified through clinical narratives, artificial intelligence, and natural language processing, followed by validation through expert chart review. The lecture will discuss the practical requirements for advancing RMP-based RWD studies beyond routine post-authorization obligations toward a reproducible and regulatory-ready evidence lifecycle that connects evidence generated throughout drug development with post-marketing safety management and further development.
[Brief Introduction of Speaker]
Master’s degree in Public Health from Yonsei Univ., currently pursuing Ph.D.
Pharmaceutical, medical expert with 20+ years of experience in clinical, academic, and medical departments at Pfizer Korea, Eli Lily Korea, and Daewoong Pharma.
Specialist member of the ARICTT(Advanced Regulatory Innovation for Clinical Trials Transformation)
Expert in post-marketing safety evaluation research based on RWD
Extensive practical experience and consulting in regional and international regulations and clinical trials In full-scope