In addition to the Main Workshops, there are 7 additional Specialized Workshops with different focus to maximize your learning needs.
Specialized Workshop F1
Implementation of 2019 FDA Immunogenicity Guidance, Nab Assays Harmonization, ADA Validation Reporting, Immunogenicity Risk Assessment, Regulatory Feedbacks & Controversial Issues
Specialized Workshop F2
Advanced Cell & Gene Therapy Bioanalysis:
Recent Advancements and New Frontiers for Bioanalytical Labs on Flow Cytometry, qPCR, ELISPOT, Regulatory Requirements, CAR-T and CRISPR Assays Case Studies
Specialized Workshop M1
Advanced Biomarkers Context of Use (CoU) Development & Troubleshooting:
Challenges from Exploratory to Clinical/Confirmatory Biomarkers, Fit-for-Purpose, Context of Use (COU) and New Platforms
Specialized Workshop M2
Interpretations & Training on ICH M10 before its Adoption; Audits Outcome using 2018 FDA; Transition from Local Guidelines to ICH M10 with Gap Analysis on Controversial Issues
Specialized Workshop T1
LBA Advanced Method Development:
Solving Challenges with Innovative Approaches on Critical Reagents, Learning from Vaccine Assays, Multi-Domain Biotherapeutics, Emerging Technologies"
Specialized Workshop T2
Innovation in High Dimensional Flow Cytometry, Mass Cytometry, and Imaging Cytometry:
Solving Complex Method Development Issues in Bioanalytical Labs using Cytometry for Biomarkers, Immunogenicity, Cell Therapy and Cellular and Immuno-Oncology Assays?"
Specialized Workshop Th1
Mass Spec Advanced Method Development - Peptides, Oligos, SM and Biomarkers:
Solving Complex Challenges with Innovative Approaches on Sensitivity & Selectivity, Unstable/Sticky Compounds; Column Chemistry, Orthogonal Separations, Tissue Bioanalysis