A Roundtable discussion of the most important and controversial recommendations from the Global Bioanalysis Consortium’s (GBC) 20 Harmonization Teams will be held Monday morning 8:00-10:00 AM on 15-Oct-2012 at this year’s AAPS Annual Meeting in Chicago. Drs. Binodh DeSilva and Eric Fluhler will highlight those topics that the Harmonization Teams feel need to be discussed with the scientific, quality and regulatory communities. Dr. Brian Booth (FDA) is scheduled to provide feedback. Additionally, GBC Harmonization Team Leaders and Team members, as well as Steering Committee members attending the meeting will be present and asked to present insights into the concepts and thinking that went into the proposals.
In preparation for the discussion, we’re reaching out in advance of the meeting seeking your input on the Harmonization Team recommendations and particularly those you would like to have discussed at the Roundtable. Please go to the GBC website (http://www.globalbioanalysisconsortium.org) to review the proposals, and then come back here to post and let us know what interests or concerns you!
The European Bioanalysis Forum (EBF) is an organisation comprised of bioanalytical scientists working within the pharmaceutical industry R&D. The scope of EBF is on regulated bioanalysis of small and large molecules. We discuss on regulatory issues and aspects (new guidelines, interpretation of existing guidelines) and present our joint opinion towards regulatory bodies and our peers.
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