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: http://www.globalbioanalysisconsortium.org 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)