Connected to the GBC Steering Committee will be the Scientific Leadership Team of Harmonization Team leaders who will be working with their teams work on specific bioanalytical validation topics.
They have build and and are leading the harmonization teams which are working on a number of specific method validation or sample analysis aspects. The harmonization team leaders are responsible for:
- Assigning the harmonization team (HT) members from the experts volunteering or those that have been identified in a SC–HT leaders meetings.
- Organizing the HT meetings and documenting the discussions.
- Connecting with SC to report back on progress and/or get input from.
- Connecting with other HT leads in case of topic overlapping discussions.
Working on the content will be done by the harmonization teams. These consist of the above mentioned HT lead and subject matter experts from multiple regions. In those teams, typically a group of 5 to 10 experts, all aspects relevant for the assigned bioanalytical topic will need to be thoroughly discussed and prepared for a broader presentation in a global harmonization meeting. The teams will need to be aware of what historic discussions have occurred over the past 20 years, what was achieved so far and why we came to those decisions.
Identifying the topics for the harmonization teams is still somewhat in discussion in the GBC Steering Committee plus founding members team and but close to finalisation. The scheme shown on this page gives a good impression of our current thinking on this aspect. See also Building the Global Bioanalysis Consortium – working towards a functional globally acceptable and harmonized guideline on bioanalytical method validation