4th Workshop on Recent Issues in Regulated Bioanalysis

In continuation of 2007 - 2009 workshops, the 4th Workshop on Recent Issues in Regulated Bioanalysis (Montreal April 21-23 2010) will address both new issues and follow-ups on the progress of the resolutions that were agreed upon last year in the field of GLP/Regulated Bioanalysis.

Preliminary 2010 Lectures:

• Updates from Regulatory Agencies: AFSSAPS (France); ANVISA (Brazil); FDA (USA); Health Canada-TPD; MHRA (UK)
• Use of Dried Blood Spots (DBS) in Regulated Bioanalysis: Practical considerations, applicability and progresses.
• Updates in biostatistycal analysis in Bioequivalence/PK studies
• Ligand-Binding Assay (LBA): Recent and old Challenges and Solutions
• Regulatory indications on Follow-on Biologics/Biosimilars: the latest developments on the regulatory pathway
• Evaluation of internal standard (IS) criteria in bioanalysis.
• Is calibration curve slope still important in LC-MS/MS bioanalysis?
• How to investigate an Incurred Samples Reanalysis (ISR) failure: Real case studies & lessons learnt
• Metabolites quantification: what’s new?
• Updates from 2009 Bioanalytical conferences/groups
• Follow up on unresolved 2009 Regulated Bioanalysis Workshop discussion topics (described in the 2009 White Paper – in press – Bioanalysis Journal, January 2010)

2 Pre-Workshop short courses have been specifically designed to be offered prior to the workshop to prepare the attendees to fully benefit from this workshop.

• Short Course 1 (half day): Fundamental of Bioanalysis: Bioanalytical Method Validation (BMV) and Sample Analysis for Chromatographic and Ligand Binding Assays.
• Short Course 2 (full day): Regulated Bioanalysis: Challenges Solutions and Applications.

Detailed information can be found at http://www.canadianlcmsgroup.com/bioanalysis_glp_events.php