In addition to the sequential 3-DAY Main Workshop program, 7 full-day Specialized Workshops spreads throughout the week to give you many choices to combine Main Workshop DAYs with these Specialized Workshops based on your specific track of interest and learning needs.
Full-Day Specialized Workshop M1:
Advanced Immunogenicity Testing & Reporting of Biotherapeutics:
Harmonization of Regulations; Enhanced Cut points Approaches; Preclinical & Clinical Assessment and Clinical Relevance; Risk-based Approaches, Prediction and Mitigation; Problem Solving for Complex NAb Assays
Full-Day Specialized Workshop M2:
Biomarkers & CDx Innovative Strategies for Method Development, Validation & Sample Collection/Analysis:
From Early-Stage Development to Clinical Translation/Commercialization; Emerging Technologies and Applications; Regulatory BAV Guidelines; Biomarkers for Vaccine Study Endpoints
Full-Day Specialized Workshop T1 for Mass Spectrometry scientists:
Mass Spectrometry New Instrumentations/Technologies, New Modalities and New Challenges:
New Tools to Reach Max Sensitivity & Selectivity; Application of Novel Ionization Sources; Advanced/New Column Chemistry and Separations Techniques; Special Focus on Overcoming Non-Liquid Matrices Issues by Mass Spec
Full-Day Specialized Workshop Th1 for LBA scientists:
LBA Emerging Technologies, New Modalities and Novel Challenges:
Innovative Tools/Instrumentation/Approaches; Advancements in Critical Reagents Generation/Performance; New Challenges with Multi-Domain Biotherapeutics Assays
Full-Day Specialized Workshop Th2 for Cytometry scientists:
Flow Cytometry Bioanalysis - Rising of the 3rd Most Common/Important Technology in Bioanalytical Labs:
Applications in Biomarkers, Immunogenicity, Cell Therapy, Vaccine, Omics and Non-Liquid Matrices; Novel Techniques, Autogating Developments and Innovation in High Dimensional Cytometry
Full-Day Specialized Workshop F1:
ICH M10 BMV Guidance Day:
Interpretation, Training and Global Harmonization; Adoption and Transition from FDA, EMA, MHLW and ANVISA Guidance/Guideline to ICH M10; Updating SOPs and Audits Preparation
Full-Day Specialized Workshop F2:
Latest Advancements in Gene Therapy, Cell Therapy and Vaccine Bioanalysis:
Immunogenicity of Gene/Cell Therapies; Method Development & Validation Strategies for qPCR/ddPCR and ELISpot; Specific Developments on NGS and nanoString; Current Regulatory Expectations
See Below Agenda at a Glance to find out how to combine these Full-Day Specialized Workshops with Main Workshop DAYs:
