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

EBF - European Bioanalysis Forum - Online

The European Bioanalysis Forum has launched its website on 22 October.
Check it out at: http://www.europeanbioanalysisforum.eu/

Program Update EBF 2nd Open Symposium

The updated agenda is now available as PDF (http://www.bioanalysis-forum.com/medias/download/program%20October%202009.pdf) on EBF's conference website http://www.bioanalysis-forum.com/

Free AAPS Webinar will Discuss Design of Experiments

Powerful Statistical Tool is Focus of Event

WHO:
The American Association of Pharmaceutical Scientists (AAPS) is a professional, scientific society of approximately 12,000 members employed in industry, academia, government and other research institutes worldwide. Founded in 1986, AAPS provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to public health. AAPS offers timely scientific programs, on-going education, information resources, opportunities for networking, and professional development.

WHAT:
AAPS is pleased to present the complimentary eLearning Webinar on Application of Multifactorial DOE for the Ligand Binding Lab. This module is sponsored by the Ligand Binding Assay (LBA) Bioanalytical Focus Group and AAPS’ BIOTEC Section.

This Webinar will be conducted by Franklin Spriggs and Chad Ray, Ph.D., and moderated by William Nowatzke, Ph.D.

WHY:
This Webinar will explore how DOE is being utilized to develop and optimize LBAs for quantifying therapeutics to support studies. This module will be of interest to bioanalytical lab scientists who are involved in LBA development, design, and validation; it will provide an introduction to DOE applications to support these bioanalytical challenges using case studies.

WHEN:
October 8, 2009
12:30 PM to 2:00 PM EST

CONTACT:
For additional information about the workshop, and to register, visit http://mediaserver.aapspharmaceutica.com/meetings/webinars/lbab/lbab-info.pdf. To set up an interview with a Webinar speaker please contact Joe Catapano at 703-248-4772 or CatapanoJ@aaps.org.