APQ Open Forum: Tiered Approaches to Bioanalytical Validation: Current Practice and Stakeholder Issues

Written by APQ Open Forum Organization Committee
Drug development News Regulated bioanalysis
Where & When?

2015 AAPS Annual Meeting and Exposition, October 25-29th
7:00 PM–9:00 PM Oct 27, 2015
Hyatt Regency Orlando – Plaza F

Proposal Description

The principles of scientific validation in relation to the tiered approach to bioanalytical method validation (BMV) are being discussed more intensively in industry. Also, this year’s APQ Open Forum has made this topic a priority. An expert panel from North America (AAPS, FDA), Europe (EBF) and Japan (JBF) and the GBC will engage the APQ Open Forum delegates to discuss the opportunities offered by applying these alternative BMV standards for an array of applications. Especially in earlier phases of drug development, applying the scientific validation as an alternative for regulatory based BMV has already proven its value, but the Open Forum aims at a continued open discussion on the future development of finding the right balance between science and regulation in bioanalysis.

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We Look forward to meeting you in Orlando,
APQ Open Forum Organization Committee