Upcoming GHC Programs

 

This image presents an overview of the 2025 GHC Vaccine Hands-on Training program scheduled from October 20 to October 24 in Korea, including locations in Osong and Hwasun. The program is structured as a five-day training course combining theoretical lectures and practical laboratory sessions on vaccine lot release and quality control methods. Day 1 focuses on institutional and regulatory understanding, including introductions to MFDS and NIFDS, the national regulatory authority lot release system, and biologics standards. It also includes a special session on ADB support for regulatory system strengthening and a field visit to testing and storage facilities. Day 2 covers laboratory testing methods such as endotoxin testing using colorimetry and turbidimetry, as well as sterility testing methods including direct inoculation and membrane filtration. It also introduces WHO GBT and WLA guidelines. Day 3 provides hands-on training on Hib vaccine identification using ELISA techniques and focuses on accurate antigen detection aligned with quality standards. Day 4 includes content testing methods such as PRP measurement and influenza vaccine SRID testing, along with preservative analysis using 2-phenoxyethanol assays. Day 5 concludes with WHO GBT evaluation case studies, hands-on preparation of evaluation items, final SRID test analysis, and a graduation ceremony.

 

This image provides a detailed schedule for Day 1 of the training program held at MFDS in Osong. The day begins with participant transportation and arrival, followed by gathering and preparation for the opening ceremony. The opening ceremony includes welcome remarks, a commemorative photo session, participant introductions, and an overview of the program. The morning sessions introduce MFDS and the Global Harmonization Center, followed by lectures on the NRA lot release system and national standards of biopharmaceuticals. A session on ADB support for strengthening national regulatory systems is also included. After lunch, participants engage in field visits to MFDS facilities, including the Special Test and Evaluation Building, biopharmaceutical reference standards storage, and laboratory animal facilities. The day concludes with a transfer to the Hwasun vaccine center for continued training.

This image describes the schedules for Day 2 and Day 3, conducted at the K-VCAST training facility. Day 2 focuses on laboratory testing techniques. The morning session covers endotoxin testing methods, including theoretical explanations and hands-on practice using colorimetric and turbidimetric approaches. After lunch, participants attend sessions on WHO GBT and WLA assessments, including regulatory designation processes and benchmarking tools. The afternoon includes sterility testing theory and cleanroom entry procedures, followed by hands-on training using direct inoculation and membrane filtration methods. Day 3 focuses on Hib vaccine testing. The morning introduces national lot release testing requirements and theoretical concepts of potency and identification tests. Hands-on sessions include preparation of samples, ELISA plate coating, and antigen detection procedures. The afternoon continues with ELISA reaction analysis and concludes with a site visit to a vaccine quality control laboratory and GMP simulation facility.

This image presents the schedules for Day 4 and Day 5 of the training program. Day 4 begins with Hib vaccine content testing using the PRP method. This is followed by influenza vaccine SRID testing, including both theoretical explanations and practical exercises such as antigen preparation and plate handling. The afternoon includes analysis of preservative content using the 2-phenoxyethanol assay, covering both theory and laboratory testing. Day 5 focuses on WHO GBT evaluation practices. Sessions include introduction to evaluation criteria, sharing of evaluation experiences, and hands-on training for preparing evaluation items. After lunch, participants complete the second phase of influenza SRID testing and analyze results. The program concludes with a graduation ceremony, certificate presentation, commemorative photo session, and participant satisfaction survey. Finally, participants transfer to Seoul, marking the end of the training program.