Wednesday, February 8, 2012

GBC conference - Mark your Calendars

Global Bioanalysis Consortium
On harmonization of bioanalytical guidance

Mark your Calendars!

September 25-27, 2012

the GBC will organize the first global bioanalysis conference on the international harmonization of bioanalytical guidance

“Science-based Proposals for Global Consensus on Bioanalysis”

at the NH Conference Center Leeuwenhorst, Noordwijkerhout, The Netherlands.

The conference will bring together leaders in industry (pharma and CRO), academia, quality assurance and regulatory authorities to discuss recent thinking on regulations impacting bioanalysis, .The scientific program is currently under development and will comprise of presentations by and discussions with each of the following 20 harmonization teams:

All Molecules / All Techniques: A1 - Scope and Regulations, A2 - Tiered approaches for method validation, A3 - Method transfer, partial/cross validations, A4 - Reference standards and reagents, A5 - Sample Management, A6 – Stability, A7 - Repeat analysis and ISR, A8 – Documentation, A9 - Analytical instrument qualification, A10 - New Frontiers, A11 – Biomarkers
Large Molecules / Ligand Binding: L1 - Large molecule specific run acceptance, L2 - Large molecule specific assay operation, L3 - Assay formats, L4 - Reagents and their stability, L5 - Automation practices in LM bioanalysis, L6 – Immunogenicity: Effect on PK
Small Molecules / Chromatographic Assays: S1 - Small molecule specific run acceptance, S2 -: Small molecule specific assay operation, S3 - Chromatographic run quality assessment

Follow the GBC website: for further announcements and details on the meeting, venue and registration.


GBC Steering Committee: Shrinivas Savale (for APA-India), Shinobu Kudoh (for JBF)
Rafael Barrientos (for ACBio), Philip Timmerman (for EBF), Peter van Amsterdam (for EBF), Michaela Golob (for EBF), Mark Arnold (for AAPS), Fabio Garofolo (for CVG), Daniel Tang (for BBDS & SBDS), Binodh DeSilva (for AAPS)

1 comment:

  1. GBC Global Conference moved to Washington DC area

    Based upon the announcement that the FDA will release their draft update guidance on bioanalytical method validation this summar and subsequnetly that an AAPS-FDA Crystal City V conference is planned to be held within 90 days after release of the guidance document, the GBC SC has decided to move the GBC global conference from the Netherlands to the Washington DC area. A date can not be set yet, but the conference is planned to be held 2 days prior to the AAPS-FDA meeting.