GTH-B Program

2023 Introductory Course for Standard Practice (GxP)

The 2023 Introductory Course for Standard Practice (GxP Course) intends to provide training on international standard of quality for vaccine and biomedical product development and manufacturing known as Good Clinical, Manufacturing and Laboratory Practice (GCP, GMP, GLP – together GxP) and the basics of biosafety. Other standards not formalized by the International Committee for Harmonization (ICH) include a guideline for Good Clinical Laboratory Practice (GCLP). Trainees who wish to participate in this course will be required to have up to 6 years of experience in biomanufacturing, or relevant field.

Course Information (Offline, South Korea)
  • Course Content: Good clinical, manufacturing, laboratory practice (GCP, GMP, GLP) and biosafety for adherence to international standard of quality in vaccine and biomedical product development.
  • Course Duration: 15 working days, (3 calendar weeks)
  • Faculty: Area-specific experts
  • Hours of Training: 120 hours including hands-on training, excursion, and tests
  • Excursion Sites: Hospital clinical centers, biomedical product development and research sites, manufacturing sites
  • Target Trainees: 150 trainees from South Korea and Low- and Middle-Income Countries (LMICs).
  • Trainee Qualification: Technician, engineer, scientist, and manager with up to 6 years of experience in biomanufacturing, or related experience
  • Certificate of completion: Certificates will be issued if trainee participation exceeds 90% of the whole training, which will be assessed through exams.

2023 Introductory Course for Biologics Development and Manufacturing

The 2023 Introductory Course for Biologics Development and Manufacturing is the first training course under the program Global Training Hub for Biomanufacturing (GTH-B), supported by the South Korean Ministry of Health and Welfare (MoHW) and WHO. It focuses on the training of biomanufacturing workforce not only for Korea but for all Low- and Middle-Income Countries (LMICs) interested in the development of biomanufacturing capacity.  The 2-week course is designed as an introductory training course for the bio manufacturing workforce. It includes basic learnings across various fields related to biologics development and manufacturing.  The In-Person course also offers a great chance to network with 150+ vaccine and biomanufacturing professionals worldwide.

Course Information (Offline, Seoul South Korea)
  • Course Content: Basic vaccinology for the biomedical workforce
  • Course Duration: 10 working days, (2 calendar weeks)
  • Faculty: Area-specific experts 
  • Hours of Training: 80 hours including case study, networking workshop and excursions.
  • Excursion Sites: hospital clinical centers, biomedical product development and research sites, manufacturing sites
  • Target Trainees: 150 trainees from South Korea and LMICs.
  • Certificate of completion: Certificates will be issued if trainee participation exceeds 90% of the whole training, which will be assessed through exams during the course.

2022 Introductory Course for Biologics Development and Manufacturing (Online Course)

The 2022 Introductory Course for Biologics Development and Manufacturing (Online Course) is a 20-hour online course for vaccine and biomanufacturing professionals who wish to learn from a distance. Compared with the 2022 Introductory Course for Biologics Development and Manufacturing offline course, this course boasts a compact training curriculum with the most essential biologics development topics covered in 20 hours.

Course Information (Online, IVI Online Campus)
  • Course Content: Basic vaccinology for the biomedical workforce
  • Course Duration: 5 working days, (1 calendar week) 
  • Faculty: Area-specific experts 
  • Hours of Training: 20 hours online
  • Target Trainees: Number of trainees unlimited.

2022 Introductory Course for Standard Practice (GxP Course) Online Course

The 2022 Introductory Course for Standard Practice (GxP online course) intends to provide training on international standard of quality for vaccine and biomedical product development and manufacturing known as Good Clinical, Manufacturing and Laboratory Practice (GCP, GMP, GLP – together GxP) and the basics of biosafety. Other standards not formalized by the International Committee for Harmonization (ICH) include a guideline for Good Clinical Laboratory Practice (GCLP).



Course Information (Online, IVI online campus)

  • Course Content: Good clinical, manufacturing, laboratory practice (GCP, GMP, GLP) and biosafety for adherence to international standard of quality in vaccine and biomedical product development.
  • Course Duration: On-demand lecture from 16th December 2022.
  • Faculty: Area-specific experts
  • Hours of Training: about 20 hours in total.
  • Target Trainees: Number of trainees unlimited all around worlds.
  • Certificate of completion: Certificates will not be issued for this online course.

2022 Introductory Course for Biologics Development and Manufacturing

The 2022 Introductory Course for Biologics Development and Manufacturing is the first training course under the program Global Training Hub for Biomanufacturing (GTH-B), supported by the South Korean Ministry of Health and Welfare (MoHW) and WHO. It focuses on the training of biomanufacturing workforce not only for Korea but for all Low- and Middle-Income Countries (LMICs) interested in the development of biomanufacturing capacity.  The 2-week course is designed as an introductory training course for the bio manufacturing workforce. It includes basic learnings across various fields related to biologics development and manufacturing.  The In-Person course also offers a great chance to network with 150+ vaccine and biomanufacturing professionals worldwide.

Course Information (Offline, Seoul South Korea)
  • Course Content: Basic vaccinology for the biomedical workforce
  • Course Duration: 10 working days, (2 calendar weeks)
  • Faculty: Area-specific experts 
  • Hours of Training: 80 hours including case study, networking workshop and excursions.
  • Excursion Sites: hospital clinical centers, biomedical product development and research sites, manufacturing sites
  • Target Trainees: 150 trainees from South Korea and LMICs.
  • Certificate of completion: Certificates will be issued if trainee participation exceeds 90% of the whole training, which will be assessed through exams during the course.

2022 Introductory Course for Standard Practice (GxP Course)

The 2022 Introductory Course for Standard Practice (GxP Course) intends to provide training on international standard of quality for vaccine and biomedical product development and manufacturing known as Good Clinical, Manufacturing and Laboratory Practice (GCP, GMP, GLP – together GxP) and the basics of biosafety. Other standards not formalized by the International Committee for Harmonization (ICH) include a guideline for Good Clinical Laboratory Practice (GCLP). Trainees who wish to participate in this course will be required to have up to 6 years of experience in biomanufacturing, or relevant field.

Course Information (Offline, South Korea)
  • Course Content: Good clinical, manufacturing, laboratory practice (GCP, GMP, GLP) and biosafety for adherence to international standard of quality in vaccine and biomedical product development.
  • Course Duration: 15 working days, (3 calendar weeks)
  • Faculty: Area-specific experts 
  • Hours of Training: 12 hours including hands-on training, excursion, and tests
  • Excursion Sites: Hospital clinical centers, biomedical product development and research sites, manufacturing sites
  • Target Trainees: 300 trainees from South Korea and Low- and Middle-Income Countries (LMICs).
  • Trainee Qualification: Technician, engineer, scientist, and manager with up to 6 years of experience in biomanufacturing, or related experience
  • Certificate of completion: Certificates will be issued if trainee participation exceeds 90% of the whole training, which will be assessed through exams.

Consultation for LMIC’s Vaccine and Biologics Manufacturing Process

On-site due diligence and following up the recommended action items for improvement are good method for biologics developers and manufacturers to check their own readiness and be prepare for market authorization. This consultation will provide on-site due diligence to check whether learnings from the courses are well applied, make recommendations for improvement, and consultation for the biological product development. 

Information of Consultation (Offline, site of consultation)

  • Customized On-Site Consultation: Other than the usual on-site due diligence, a customized on-site training can be conducted based on the need of the targeted manufacturer.
  • Number of Entities: A minimum number of 3 entities is to be consulted in the year of 2022.
  • Selection Process: The selection of entities for consultation is done based on the criteria agreed with Korea MoHW.
  • Consulting Expertise: The consulting team consists of IVI and external experts with minimum 20+ years of expertise.
  • Areas of training and consulting: Can include facility readiness, production process, quality management, clinical development, regulatory affair, etc.
  • Manufacturing site who are interested in onsite training and consultation can reach to Alice Lee (eunjulee@IVI.INT) for more information.