FDA OSIS is hosting a webinar for bioanalytical labs to help educate them on expectations for a number of study types including animal GLP and human Bioavailability and Bioequivalence studies on June 13th, 2024 from 9:00 – 11:30 AM ET. This appears to be a very interesting session for bioanalytical scientists and QA staff that support them.
From the announcement page:
Presentations will:
- Describe the Mission and Vision of the Office of Study Integrity and Surveillance (OSIS).
- Discuss the basic elements needed for a bioanalytical lab to successfully undergo an FDA inspection.
- Provide an overview of compliance programs dealing with inspections of facilities that perform Good Laboratory Practice (GLP), Animal Rule (AR), In Vivo Clinical Bioavailability (BA) -Bioequivalence (BE), In Vivo Analytical Bioavailability-Bioequivalence Studies.
- Engage attendees to work through case studies representative of the above programs.
#fda #OSIS #GLP #Bioequivalence #bioavailability
https://www.fda.gov/drugs/news-events-human-drugs/osis-workshop-cder-inspections-good-laboratory-practice-and-bioavailabilitybioequivalence-study
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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