On June 30, 2020, from 9:00 a.m. to 5:30 p.m. (EDT),the U.S. Food and Drug Administration (FDA) will host a free regulatory training for industry on bioanalysis requirements and expectations. Focused on how FDA’s Center for Drug Evaluation and Research (CDER) approaches various issues in bioanalysis, the workshop aims to provide participants with a better understanding of how FDA performs bioanalysis. Topics to be covered, among others, include:
- Bioanalytical method validation: history, process, and regulatory perspectives;
- Biosimilars;
- Regulated bioanalysis for large molecules;
- Regulated bioanalysis for small molecules;
- Drugs and biologics;
- Bioanalysis of unstable analysis;
- Repeat analysis; and
- A case study on bioanalytical approaches to mitigate issues identified during bioequivalence clinical site inspection.
Registration is required.