In April 2017, the centre hosted a symposium and a WHO informal consultation on development of WHO guidelines on procedures and data requirements for changes to approved biologicals. These meetings brought together stakeholders from WHO, national regulatory authorities, and industry to discuss critical issues related to guidelines development, regulatory frameworks for approved biotherapeutics, and challenges faced by manufacturers and regulators.
The centre has provided training on the use of equipment for vaccine quality control in the Western Pacific Region annually since 2015. In 2017, 10 experts participated from national regulatory authorities and national control laboratories in Cambodia, the Lao People's Democratic Republic, Mongolia and Viet Nam. Through in-class sessions and hands-on practice, participants strengthened their knowledge and skills in the use of autoclave, ultraviolet-visible spectrophotometry (UV/VIS) spectrophotometer, microscopy, and high performance liquid chromatography (HPLC).
The centre co-hosted the Second Meeting of the Network of National Control Laboratories for Vaccines and Biologicals in the Western Pacific Region in September 2017. The network meeting provided an opportunity for countries such as Canada, China, Japan, Malaysia, the Republic of Korea and Viet Nam to share information on their vaccine lot release systems, risk-based approaches and quality control of blood products. Through the network these countries regularly communicate, coordinate and share study results and they are now embarking on collaborative studies.
The centre also co-hosted the Third WHO Implementation Workshop on the Quality, Safety and Efficacy of Typhoid Conjugate Vaccine held in Osong, the Republic of Korea in November 2017. Representatives from national regulatory authorities, WHO, the International Vaccine Institute, and vaccine manufacturers had in-depth discussions on regulatory issues. Key topics included measurement standards and assay standardization for typhoid conjugate vaccines, implementation of WHO guidelines, and quality assessment based on physic-chemical analysis and clinical evaluation.
In addition to playing a key role in advancing research and technical support, the centre has also actively participated in the Republic of Korea's Alliance of WHO Collaborating Centres, in which there are 22 member centres. The alliance was formed in 2015 following the First Regional Forum of WHO Collaborating Centres in the Western Pacific in 2014. The Alliance meets quarterly to share their activities and strengthen collaborative relationships. Dr Sunhee Lee, Director General of NIFDS was elected President of the Alliance in July 2017. In her inaugural address at the 11th Alliance meeting, Dr Lee spoke of prioritizing contributions to global health and promoting close collaboration among the centres.
Participants of the WHO informal consultation on development of guidelines on procedures and data requirements for changes to approved biotherapeutic products including biosimilars.
Participants of the 11th meeting of the Alliance of WHO Collaborating Centres in the Republic of Korea
Participants of the WHO implementation workshop on the quality, safety and efficacy of typhoid conjugate vaccines