Regulatory systems play a key role in assuring the quality, safety, and efficacy of medical products. Effective regulatory systems are an essential component of health systems and contribute to desired public health outcomes and innovation.
Regarding the evaluation of medicines and vaccines regulatory programmes, a Global Benchmarking Tool (GBT) has been developed to harmonize and unify all previously used assessment tools and mechanisms. However, it is only since the assessment criteria for national blood regulatory systems were adopted by the Expert Committee for Biological Standardization in 2014, that benchmarking has been introduced for blood products. The GBT+ blood has been published in November 2019. The GBT+ blood ensures policy coherence and reduces the unnecessary burden of benchmarking, costs and duplications for Member States.
To introduce and describe the use of the GBT + blood for benchmarking of national regulatory systems in the area of blood products (including whole blood, blood components and plasma derived medicinal products) the Health Products Policy and Standards department (HPS) and Regulation and Prequalification department (RPQ) will hold the above mentioned webinar with simultaneous translations. There will be two sessions:
- a morning session from 09:00 to 11:00 CET: with simultaneous interpretation in English, Arabic, Chinese and Russian; and
- an afternoon session from 16:00 to 18:00 CET: with simultaneous interpretation in English, French and Spanish.
During the webinar the following topics/presentations will be discussed:
- WHO Regulatory Systems Strengthening program, benchmarking and overview of the WHO GBT Plus Blood;
- WHO GBT Plus Blood, indicators and factsheets;
- Experience with pilot assessments during development of the GBT Plus Blood;
- Promoting the use of the GBT Plus Blood for capacity building in the WHO Regions.
It is intended that blood regulatory officials from Ministries of Health, National Regulatory Authorities and Directors of the major blood establishments will participate in the webinar.