2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections

• DOI: 10.4155/bio.11.192
• Publication Date: 2011-09-26T13:14:21Z
• Authors: Fabio Garofolo; Mario L Rocci; Isabelle Dumont; Suzanne Martinez; Steve Lowes; Eric Woolf; Peter van Amsterdam; Surendra Bansal; Ariadna Cristina ...; Ronald Bauer; Brian P Booth; Montserrat Carras...; Binodh DeSilva; John Dunn; Keith Gallicano; Dominique Gouty; Stacy Ho; Richard Hucker; Mohammed Jemal; Noriko Katori; Olivier Le Blaye; Jean Lee; Wenkui Li; Steve Michael; Corey Nehls; Robert Nicholson; Eric Ormsby; Daniel Tang; CT Viswanathan; Russell Weiner; Graeme Young
• Keywords: Bioanalysis; Excellence; White paper

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 regulatory agencies to discuss, review, share perspectives, provide potential solutions agree upon consistent approach recent issues bioanalysis of both small large molecules. High quality, better compliance regulations scientific excellence are foundation this workshop. As previous editions significant event, recommendations were made consensus reached among panelists attendees, including industry leaders experts representing global bioanalytical community, many 'hot' topics bioanalysis. This 2011 White Paper is based conclusions from workshop, aims practical reference guide those topics.