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6th Workshop on Recent Issues in Bioanalysis (6th WRIB)

Where Regulators and the Industry Convene

March 28-29, 2012, San Antonio, TX, USA
Courses: March 26-27, 2012
Hotel Marriott San Antonio Riverwalk

The 6th Workshop on Recent Issues in Bioanalysis will be again where regulators and the industry convene, and continue to focus on the latest challenges bioanalytical industry is facing:

  • The Year of the NEW Guidances in Bioanalysis - Comments and Questions on the following New Guidances will be collected before the meeting to prepare this interactive open discussion with the Regulators:
    • The New US-FDA Bioanalytical Guidance
    • The New Europe-EMA Bioanalytical Guidance
    • The New Brazil-ANVISA Bioanalytical Guidance (RDC 899)
    • The New Canada-TPD Bioanalytical Guidance (Section 2.6 Bioanalytical Methodology)
    • The New China-SFDA Bioanalytical Guidance (Guan on Quantitative Analysis of Biosamples)
    • Updates on the Status of the Bioanalytical Guidance in Japan
  • Advanced Method Development and Troubleshooting in Bioanalysis;
  • LM & LBA: Recent Issues related to Large Molecules (LM) and Ligand Binding Assay (LBA) bioanalysis;
  • LM Bioanalysis by LC-MS/MS;
  • Innovations in Bioanalysis: From Drug Discovery to Drug Development;
  • Regulatory Findings from Audits/Inspections - open discussion with industry leaders and regulators;
  • Panel Discussions to collect your inputs for 2012 White Paper in Bioanalysis.

Three courses have been specifically designed to be offered prior to the workshop to prepare the attendees to fully benefit from this workshop.

  • Course 1: "LC-MS/MS Bioanalytical Advanced Method Development: Up-to-date Scientific Approaches"
  • Course 2a: "Bioanalysis of Large Molecule & Biomarkers: Advanced Ligand Binding Assays (LBA) Method Development and Troubleshooting"
  • Course 2b: "Bioanalytical Method Validation and Sample Analysis (BMV & SA): Challenges, Solutions, Applications , Global Industry Standards and New Regulations"

 

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