CFABS

 

Method Development Challenges, Regulatory Findings, and Innovations
in Bioanalysis

5th Workshop on Recent Issues in Bioanalysis (5th WRIB)

"Discussing, Reviewing, Sharing Perspectives, Providing Potential Solutions and Agreeing upon a Consistent Approach
on the Recent Issues in Bioanalysis "

April 13-14, 2011, Montreal, Canada
Short Courses: April 11-12, 2011
Hotel Marriott Chateau Champlain

White Paper from 5th WRIB  |   Highlights  |   Workshop Lectures   |   Pre-Workshop Courses   |   Agenda   |   Sponsors  

 

METHOD DEVELOPMENT CHALLENGES

  • Discuss Hot Topics in Bioanalysis including LC-MS/MS Assays, LBA Assays, Biomarkers, Biologics, and Current Scientific Challenges in Method Development, Validation and Sample Analysis of both small and large molecules

 

INNOVATION IN BIOANALYSIS

  • Explore Innovation in Bioanalysis: From DD to DD - from drug discovery to drug development
    • Accelerator mass spectrometry (AMS) & microdosing
    • High resolution/Accurate Mass (QTOF)
    • LC-MS quantitative analysis of therapeutic proteins

 

RECENT FINDINGS FROM REGULATORY AGENCIES

  • Improve the quality of data with the help and suggestions from the global regulatory agency experts. Questions and feedbacks on findings will be collected and prepared beforehand to be addressed during the meeting - effective two way communications will be facilitated between the industry and the regulatory agencies worldwide including US FDA, Europe EMA, Health Canada, Japan MHLW, Brazil ANVISA.

  • Provide Technical and Scientific updates on Harmonization of Bioanalysis Guidance - between FDA and EMA

 

PREPARATION OF THE 2011 WHITE PAPER

  • Influence and actively contribute in the preparation of the 2011 edition of the White Paper in Bioanalysis. The 2011 White paper will continue "to provide an authoritative guide that addresses major recent issues and hot topics and how to solve them."
  • CVG believes that since bioanalytical science, techniques and regulations are evolving very fast, it is important to issue a scientifically sounding White Paper in Bioanalysis each year to educate leaders from the bioanalytical community and help them make decisions and implement solutions.

  • The 2010 Workshop White Paper was based on the conclusions and consensus points from the 4th Montreal Regulated Bioanalysis Workshop, was shared with regulatory agencies, and is currently published on Bioanalysis Journal.
    View 2010 White Paper from the 4th Montreal Regulated Bioanalysis Workshop - The Most Read Article of Bioanalysis Journals!

  • The 2009 Workshop White Paper was shared with regulatory agencies and published on Bioanalysis Journal.
    View 2009 White Paper from the 3rd Montreal Regulated Bioanalysis Workshop - The Second Most Read Article of Bioanalysis Journals!

 

High quality, better compliance to regulations and scientific excellence are the foundation of this workshop.

 

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