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, and Risk Assessment of Biotherapeutics:
Prescription Drug Labeling new FDA Draft Guidance; Harmonization of Regulations; Enhanced Tiered / Cut Points Approaches; Clinical Relevance, Preclinical & Clinical Assessment; Risk-based Approaches, Prediction and Mitigation; NAb Assays, Integrated Approach and ADA Comparison & Monitoring
Full-Day Specialized Workshop M2:
Biomarkers & CDx Innovative Strategies for Method Development, Validation, and Sample Collection/Analysis:
From Early-Stage Development to Clinical Translation/Commercialization; Complex & Challenging Applications; Regulatory CDx & BAV Guidelines; Biomarkers for Vaccine Study Endpoints
Full-Day Specialized Workshop Th1 for LBA scientists:
LBA Novel Technologies, Novel Modalities, and Novel Challenges:
Innovative Tools/Instrumentation/Approaches; Advanced Strategies in Automation; Advancements in Critical Reagents Deep Functional Characterization; Problem Solving for Novel Modalities, Rare Matrices and Complex NAb Assays
Full-Day Specialized Workshop Th2 for Cytometry scientists:
Flow Cytometry Bioanalysis - Rising of the 3rd Most Common/Important Technology in Bioanalytical Labs:
Importance of learning Flow, Mass, Imagine & Spectral Cytometry Bioanalysis and Major Applications in Biomarkers, Immunogenicity, Cell Therapy, Vaccine, Omics and Non-Liquid Matrices; Novel Techniques, Autogating Developments and Innovation in High Dimensional Cytometry - Social Networking Reception and Dinner is also Included - Flow Cytometry Day and Night!
Full-Day Specialized Workshop F1:
ICH M10 BMV Guidance & Global Harmonization Day:
Consideration on ICH M10 Adoption, Transition and Interpretation; Interactive Industry/Regulators' Discussions on Audits/Inspections/Submissions Outcomes; Recent Issues in Regulated Bioanalysis for Small & Large Molecules; Gap Analysis on New Controversial Issues; Evolving Regulatory Standards for Chromatographic & Ligand Binding Assays
Full-Day Specialized Workshop F2:
Latest Advancements in Gene Therapy, Cell Therapy, and Vaccine Bioanalysis:
Immunogenicity & Risk Assessment of Gene, Cell Therapies & Vaccines; LNP & Viral Vectors for Oligonucleotide-based Therapy/Vaccines; qPCR/ddPCR Method Development & Validation Strategies; NGS & nanoString New and Specific Developments; Current Regulatory Expectations
See Below Agenda at a Glance to find out how to combine these Full-Day Specialized Workshops with Main Workshop DAYs:
