2025 Workshop

 
This image presents the detailed schedule of the 2025 Global Harmonization Center International Workshop on Pharmacovigilance, held on November 3 and the morning of November 4, 2025, in Seoul, Korea. The event takes place at Sky31 Convention, Lotte World Tower. The workshop theme focuses on evaluating WHO Listed Authority (WLA) vigilance systems and strengthening global regulatory cooperation. Day 1 begins with registration, followed by an opening session that includes welcome remarks, introduction of key attendees, and a group photo session. The first session provides an overview of WHO Global Benchmarking Tool (GBT) and WLA for regulatory system strengthening. It covers the WLA evaluation and designation process, current status, and WHO’s approach to assessing regulatory maturity levels. The second session presents Korea’s experience in WLA designation, including inter-agency cooperation and pharmacovigilance system development. After lunch, the program continues with practical approaches to GBT evaluation for WLA designation. Topics include evaluation methods from an international standard perspective, preparation strategies for listed authorities, and case studies in pharmacovigilance systems, including adverse event reporting and risk management. Speakers from international organizations and national agencies share insights into regulatory evaluation practices and real-world implementation. A special session follows, focusing on pharmacovigilance through artificial intelligence and digital transformation, highlighting current trends and future directions in safety management. Another session discusses the Asian Development Bank’s role in strengthening regulatory systems in Asia. Day 2 morning continues with sessions on WLA vision and global cooperation. Topics include key focus areas, expected outcomes, and future plans for WLA designation. Industry perspectives are presented regarding the impact of WLA listing on global regulatory environments and domestic industries. The workshop concludes with a panel discussion addressing collaboration strategies, joint initiatives, and the broader impact of WLA designation on regulatory trust and international cooperation.
 
This image presents the schedule for the afternoon session of the 2025 Global Harmonization Center International Workshop, focusing on Medical Device Vigilance, held on November 4, 2025, in Seoul, Korea. The session begins with an opening segment that includes welcome remarks, introduction of participants, and a group photo session. The first set of presentations introduces medical device adverse event management systems from different countries. Singapore’s system is presented, covering its national framework for managing medical device adverse events. This is followed by a session on the European Union system, including regulatory authorities such as the European Medicines Agency and relevant directives, along with case studies. Another session introduces Australia’s medical device vigilance system, including regulatory practices and practical examples. After a health break, the program continues with presentations on South Korea’s medical device vigilance system. Topics include adverse event collection, reporting processes, investigation procedures, and case analysis methods. A session on real-world data explains how actual clinical and usage data are utilized for analyzing medical device safety events. Additional presentations cover case studies of domestic companies expanding into global markets, focusing on regulatory strategies and safety management planning. The workshop concludes with a panel discussion on global regulatory system strengthening solutions in the field of medical devices. The discussion includes contributions from speakers, industry experts, and participants, focusing on collaboration, policy development, and future directions for international regulatory cooperation.