Course Description:
Day 1: 12:00 PM - 1:30 PM
This webinar will summarize the recent international initiative to develop a single Bioanalytical Method Validation Guidance that would be used by all of the regulatory agencies around the globe. In recent meetings, consensus from the FDA, HRMA, EMEA, CVG, AAPS, EBF (European Bioanalysis Forum), Health Canada and world Biotech and Pharmaceutical Industry leaders on the best course of action for the harmonization of bioanalytical method validation (BMV) guidance has been delineated. In fact, representatives from the FDA have been pleading for globalization instead of harmonization so as to expedite this initiative.
During these meetings, particularly the recent Montreal CVG meeting in April 2010, the FDA provided updates, and consensus was made pertaining to more than ten hot topics applicable to bioanalytical method validation practices, including LBA, biomarkers, PK repeats and ISR, dried blood spots and Part 11.
The importance of these consensuses is amplified given the recent EMEA/CHMP BMV draft guidance provided last year, and the revision of the FDA BMV guidance recently announced to be circulated for review as early as next year. The EMEA draft guidance will also be discussed as it applies, as well so as to provide the attendee a complete scope of this paradigm.
|
