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.
(Click below each blue title to see more details of each training session)
Training Session M1 - 7am - 5:30pm
"New Insights in Biomarkers Assays Validation (BAV): From US FDA BMV (2018) Guidance, Revised C-Path (2018) White Paper and CLSI Draft Document H62 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 and CLSI Draft Document H62 versus traditional Lee (2006) Fit-for-Purpose White Paper New: Providing feedback on December 2018 US FDA draft "Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff"
Training Session M2 - 7am - 5:30pm
"IMPLEMENTATION of 2018 FDA BMV Final Guidance LCMS & LBA: Regulatory Inputs, Inspections Outcomes/Observations and Industry Experiences" - Lessons Learned from Case Studies in Small Molecules & Biotherapeutics
Training Session T1 for LBA scientists - 7am - 6:30pm
"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 Th1 for LCMS scientists - 7am - 6pm
"Mass Spectrometric Novel & Advanced Method Development Strategies for Large Molecules Bioanalysis: Therapeutic Proteins, ADC, Biomarkers, Oligonucleotides, Peptides & New Modalities" - Expand your Experience in PK Assays, Biotransformation and Biomarkers Assays, and Learn LCMS Technology Most Recent Updates and Refinements
Training Session F1 - 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 New! Interpretation & Implementation of the 2019 FDA Final Immunogenicity Testing Guidance - Focus on Key Components of "Immunogenicity Testing of Therapeutic Protein Products - Developing and Validating Assays for Anti-Drug Antibody Detection Guidance""
Training Session F2- 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
©2016 WRIB. All Rights Reserved.