Welcome to the website of the

Global Bioanalysis Consortium (GBC)

 
Interest Registration for joining one of the Harmonization Teams or as a Harmonization Team Leader has been closed except for Japan given the dramatic circumstances.
 
During April the SC has been active with identifying and contacting the Harmonisation Team Leads, getting their reconfirmation and bringing them all up to speed. That process is to be completed the first week of May. Shortly thereafter applicants will be contacted by one or more HT-leads inviting them to join their team.
 
The HT-Ls will follow the following principles in building their teams:
  • Selected team members should be experienced in the topic
  • No region should be excluded, unless the region SC confirms lack of expertise, the subject matter is out of scope or insufficient experts volunteer
  • No region should have >50% of team members.
  • Size of teams can vary (advice: 5-10 members, depending on the topic)
  Thank you all again for showing your interest and support.
 
 

Our Mission:
 
The Global Bioanalysis Consortium (GBC) is a world wide organisation consisting of representatives of scientific associations with the mission to harmonize and merge existing or emerging bioanalytical guidances to create one, unified consensus document that can be presented to the regulatory bodies/health authorities in various countries.


Our Goals and Objectives:

To bring together stakeholders from the pharmaceutical industry, contract research organizations and academia to share current understanding of bioanalysis guidelines, identify differences in these guidelines or differences in the interpretation or application thereof to routine regulated bioanalysis.

To come forward with recommendations to Health Authorities and regulatory bodies worldwide on globally agreed best practices for Bioanalytical Method Validation (BMV) and application of such methods/technologies to the analysis of drugs of all molecular sizes in support of clinical and nonclinical studies.
 
 

Disclaimer

The views expressed on this website are those of the Global Bioanalysis Consortium
and do not necessarily reflect the representative affiliation or company's position on the subject.