In addition to the Sequential 3 Main Workshop Days, 6 full-day Training Sessions will spread throughout the week to give you the flexibility to choose different combination of Workshop Days and Training Sessions based on your specific track of interest and learning needs.
Training Session M-1 - 7am - 5:30pm
"New Insights in Biomarkers Assays Validation (BAV): From US FDA BMV (2018) Guidance & Revised C-Path (2018) White Paper to Fit-for Purpose Validation - Case Studies from LBA and Flow Cytometry" - Evolution of BAV strategy based on New US FDA BMV Guidance & Revised C-Path White Paper versus traditional Lee (2006) Fit-for-Purpose White Paper
Training Session M-2 - 7am - 5:30pm
"Advancements in Biotherapeutics Bioanalysis by LCMS, HRMS and Hybrid LBA/LCMS: state-of-the-art PK Assays, Biotherapeutics Biotransformation, ADA Assays and Protein Biomarkers Assays" - Expand your Experience in Biotherapeutics Bioanalysis and Learn Hybrid Technology Most Recent Updates and Refinements
Training Session T-1 for LBA scientists - 7am - 5:30pm
"Current & Effective Strategies for Critical Reagent Characterization, Storage, LT Stability, Re-testing and Life Cycle Management for LBA & Flow Cytometry PK, ADA and Biomarkers Assays & Bioanalytical Troubleshooting of Critical Reagents Issues" - Recent Advancements and New Frontiers for the Bioanalytical Lab
Training Session Th-1 for LCMS scientists - 7am - 5:30pm
"Regulatory inputs & Industry experiences on Implementing the 2018 FDA BMV Final Guidance: Lessons Learned from Case Studies in Small Molecules" - The latest updates for companies involved in Regulated Bioanalysis
Training Session F-1 - 7am - 5:30pm
"Cut Points – 'The Evolution': Issues in Statistical Evaluation & current Regulatory Perspectives of Cut Points and impact on Immunogenicity Assay development" - Building on Industry/Regulators’ recommendations & Working together for harmonization
Training Session F-2- 7am - 5:30pm
"The Gene Therapy Bioanalytical Challenges: PK/Biodistribution, Immunogenicity and Shedding Assays, qPCR & ELISPOT/Flow Cytometry in Bioanalytical labs, and Regulatory Perspectives" - What you need to know to develop bioanalytical assays for Gene Therapy and how Gene Therapy is impacting Bioanalysis in both Pharma and CRO - Multiple platforms & multiple approaches to deal with unsolved bioanalytical issues
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