MONDAY Webinar: Bioanalytical Method Validation – June 17, 2019

WEBINAR: How should I measure this? An FDA perspective on the Bioanalytical Method Validation MONDAY, June 17, 2019 10:00 a.m. – 2:00 p.m. Eastern This webinar is FREE. Register Now Why attend? Understand how FDA/CDER reviewers use the bioanalytical method validation guidance to conduct drug and therapeutic biologics reviews Hear the changes in the 2018 BMV guidance and how those changes impact sponsors, contract research organizations, and academia Learn what to expect during FDA bioanalytical site inspections and how to be prepared Understand the aspects of FDA’s guidance on Bioanalytical Method Validation and learn reviewers’ perspective on the assessment of bioanalytical data submitted INDs, NDAs, ANDAs, and BLAs Increase knowledge on how to provide high quality data to support successful applications Understand how FDA conducts analytical inspections of BA/BE studies to verify the analytical methods are validated and analyte concentrations from clinical samples are accurate and precise Applicants and bioanalytical laboratories can provide high quality data to support successful application approval when they have a more complete understanding of CDER expectations Understand the expectations for high-quality bioanalytical data Intended Audience Regulatory affairs professionals working on Investigational New Drug Applications (INDs), NDAs, ANDAs, and BLAs Researchers involved with testing of new drugs or new formulations of drugs, therapeutic proteins or biosimilar products Sponsors, contract research organizations, and academic professionals interested in bioanalytical aspects of drug and therapeutic biologic development