Background
Low- and Middle-Income Countries (LMICs) face significant inequities in terms of access to vaccines and other biologics and are making efforts to establish biological manufacturing within their regions. Establishing such manufacturing capacity, through bilateral technology transfer or local R&D efforts, is often hindered by the lack of a trained workforce in biomanufacturing.
To address this gap and to build biomanufacturing capacity in LMICs, the World Health Organization (WHO) and the Ministry of Health and Welfare (MoHW) of the Republic of Korea established the Global Training Hub for Biomanufacturing (GTH-B). The hub's mandate is to provide training in the manufacturing of high-quality vaccines and biologics in an industrial setting to resolve inequality in access to vaccines and biologics worldwide by expanding manufacturing capacity in LMICs.
Since 2022, the GTH-B has conducted two editions of the 'Introductory Course for Biologics Development and Manufacturing' and the 'Introductory Course for Standard Practice (GxP)' through the International Vaccine Institute (IVI), providing GTH-B training to about 670 people in more than 50 LMICs.
For the third year, the Republic of Korea, in agreement with WHO, is organizing a new training operated by the GTH-B through IVI, focusing on the introduction to standard practice (GxP) in biomanufacturing from October to November 2024 for 150 trainees from LMICs.
Proposed Dates for Introductory Course for Standard Practice (GxP)
- Pre-Online Course: Monday, October 7, 2024 – Sunday, October 27, 2024 (3 Weeks/Tentative)
- In Person Course: Monday, October 28, 2024 – Friday, November 15, 2024 (3 Weeks)
Course Objectives
The purpose of this Introductory Course for Standard Practice (GxP) is to equip participants representing the biomanufacturing workforce from LMICs with the essential skills required to operate according to current good practices.
After completing the course, participants will be equipped with the knowledge and skills required to operate in a biomanufacturing facility according to international GxP standards. By investing in workforce development, the hub will support ongoing initiatives in local bioproduction and strengthen knowledge sharing between manufacturers. This includes, but is not limited to, didactic and practice sessions on Good Laboratory Practice, Good Clinical Practice, Good Clinical Laboratory Practice, Good Manufacturing Practice, and Biosafety.
Content and Structure
Course content is currently being developed, and applicants can refer to Appendix 1 for the tentative course agenda.
This course will consist of three weeks of pre-online sessions followed by three weeks of in-person sessions. At the end of every session, participants will be required to test their learning through online quizzes to complete each session. Certification will be awarded to participants who have passed 90% of all required quizzes and 100% of pre-online sessions.
Eligibility, Limitation, and Selection Criteria
The course targets individuals employed by entities formally registered in LMICs and currently involved in the production of bioproducts, including vaccines, therapeutics, monoclonal antibodies, etc.
All training and services will be provided to the individuals selected for training only and cannot be transferred or shared. Participants are expected to demonstrate in their application how the experience gained during the training program will be applied and are required to commit to returning to their home institution upon completion of the training.
Applicants must meet the following qualifications to be considered eligible for the course:
- Have an educational background in life sciences.
- Hold a position as a technician, engineer, scientist, or manager with up to 6 years of experience in biomanufacturing or a related field.
- Be employed by a company registered as a legal entity in an LMIC conducting activities in the scope of biomanufacturing.
- Be a citizen of, and resident in, a LMIC
- Have at least an intermediate level of proficiency in spoken and written English.
- Demonstrate in the application how the acquired knowledge, skills and competencies during the training will be applied after the training in the institution the participant is coming from
- Explain in the application the relevance to a professional project
Application Procedure
The online application form is available at the following link: https://ivionlinecampus.ivi.int/
The following information must be provided:
- First and family name
- Date of birth, gender, and other personal information
- Copy of passport
- Name, address, telephone number and e-mail address of institution where the applicant is employed
- Educational qualifications and level of English proficiency
- A description of the applicant’s current post and work
- A description of how the applicant, if selected, plans to apply the acquired skills and knowledge after returning to home country/institution
- A letter of endorsement from the Director of the applicant’s institution confirming his/her capability to successfully undertake the proposed training and certifying the applicant's current employment status (Endorsement letter sample is available at the application page on the website)
Deadline for Application Submission
All applications must be submitted online at https://ivionlinecampus.ivi.int/ by 19 July 2024, 18:00 (KST).
Selection Process
The selection process includes the following steps:
- Eligible applications will be reviewed by the selection committee formed by members recommended by MoHW in South Korea and WHO.
- When the selection process is completed, the selected participant will be informed of the next steps and necessary information by e-mail.
- Due to limited capacity, up to 5 participants maximum from each organization, and up to 10 participants maximum from each country will be allowed to participate. The decision for the selection will be made by the selection committee in collaboration with the home institution.
- For the institutions involved in animal vaccine production only and wishing to send participants to the training, a letter from the institution should be addressed to the GTH-B with a statement regarding an institutional plan to expand its scope to human vaccine.
Financial Provisions
The course is offered free of charge to participants. Accommodation and breakfast will be provided during the course days and weekends. Lunch will be provided on weekdays only and is not included on weekends.
The trip cost to/from Seoul, Republic of Korea will NOT be covered. Applicants must secure the travel costs at their own expense. Selected applicants will be responsible for obtaining any vaccinations and visas necessary for travel.
Equality, Diversity, and Inclusivity
The Ministry of Health and Welfare (MoHW) of the Republic of Korea and the World Health Organization (WHO) are dedicated to promoting equality, diversity, and inclusivity in science. We particularly encourage women to apply and welcome any qualified applicants regardless of sexual orientation, ethnicity, religious, cultural, social backgrounds, or (dis)ability status.
For Further Information
For further questions related to this, please contact the course coordinator at gthb.coordinator@ivi.int.
The receipt of the applications will be automatically acknowledged via return email from gthb.coordinator@ivi.int. An acknowledgment of the application receipt does not imply that the application is complete and eligible for review.