Journal
BIOANALYSIS
Volume 3, Issue 18, Pages 2081-2096Publisher
FUTURE SCI LTD
DOI: 10.4155/BIO.11.192
Keywords
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Funding
- US FDA
- Brazil ANVISA
- European Medicines Agency
- Health Canada TPD
- France AFSSAPS
- Japan MHLW-NIHS
- Austria AGES PharmMed
- European Bioanalysis Forum
- Pharma Medica Research
- GYROS
- WIL Reseach Company
- Cetero Research
- Intertek Pharmaceutical Services
- Algorithme Pharma
- Bruker
- Waters
- iStudy Reporter Bioanalytics
- AB Sciex
- Zef Scientific
- Tandem Labs
- Advion, Worldwide Clinical Trials
- PRA International
- mSpec Group
- ICON
- Celerion
- Parker Balston
- Peak Scientific
- Bioanalysis Journal
- KCAS, Thermo Scientific
- MPI Research
- PPD
- ICF
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The 5th Workshop on Recent Issues in Bioanalysis (WRIB) was organized by the Calibration and Validation Group as a 2-day full immersion workshop for pharmaceutical companies, CROs and regulatory agencies to discuss, review, share perspectives, provide potential solutions and agree upon a consistent approach to recent issues in the bioanalysis of both small and large molecules. High quality, better compliance to regulations and scientific excellence are the foundation of this workshop. As in the previous editions of this significant event, recommendations were made and a consensus was reached among panelists and attendees, including industry leaders and regulatory experts representing the global bioanalytical community, on many 'hot' topics in bioanalysis. This 2011 White Paper is based on the conclusions from this workshop, and aims to provide a practical reference guide on those topics.
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