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 Regulated Bioanalytical Method Validation (BMV) Guidance to Fit-for Purpose Validation" - A journey of the Biomarker community across platforms, regulations and industry standards: Current Status
Training Session M-2 - 7am - 5:30pm
"Recent Advancements in Biotherapeutics Bioanalysis by LCMS, HRMS and Hybrid LBA/LCMS" - Expanding your Experience in Biotherapeutics Bioanalysis by Learning the Potential of LCMS as complementary technique to LBA
Training Session T-1 for LBA scientists - 7am - 5:30pm
"Critical Reagents & Flow Cytometry: Recent Advancements and New Frontiers for the Bioanalytical Lab " - In a fast-paced environment the need to catch up with current industry standards, regulations and emerging approaches in both Critical Reagents & Flow Cytometry is crucial for Pharma & CRO
Training Session Th-1 for LCMS scientists - 7am - 5:30pm
"LCMS & HRMS: Small Molecules Current Regulatory Challenges: Lessons Learnt - Case studies from Implementing the 2018 FDA BMV Final Guidance" - The latest updates based on Regulatory inputs & Industry experience for companies involved in Regulated Bioanalysis
Training Session F-1 - 7am - 5:30pm
"Cut Points – “The Evolution”: Issues in Statistical Evaluation 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 challenge: what you need to know and how it is impacting Bioanalysis in both Pharma and CRO" - Multiple platforms & multiple approaches to deal with unsolved bioanalytical issues
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