In addition to the Sequential 3 Main Workshop Days, 6 full-day Training Courses/Specialized Sessions will spread throughout the week to give you the flexibility to choose different combination of Workshop Days and Training Courses/Specialized Sessions based on your specific track of interest and learning needs.
Training Course M-1- full-day course
"Biomarkers Troubleshooting: Successes & Failures in Biomarkers Assays Development & Validation (BAV)" - Lesson learnt from practical biomarkers case studies depicting real-life situations in which problems need to be solved
Training Course M-2 - full-day course
"What do you need to know to be prepared for the ICH M10 BMV adoption & Global Harmonization of Bioanalytical Guidance?" - An in-depth gap analysis on controversial BMV issues in preparation of the public consultation of the ICH M10 BMV technical document
Specialized Session T-1 for LBA scientists - full-day specialized session
"LBA & Flow Cytometry for Large Molecules Advanced Method Development Challenges, Solutions and New Industry Standards with NEW Case Studies" - advanced and interactive session in LBA & Flow Cytometry where original case studies and state-of the art technologies & approaches are presented from experts in the field
Training Course Th-1 for LCMS scientists - full-day course
"Crucial importance of correct Internal Standards (IS) Response Troubleshooting & Interpretation in Effective LCMS Method Development, Validation and Sample Analysis" - Learning how to interpret “dangerous” IS behaviors & take actions through an in-depth evaluation of case studies; Putting in a place a decision-making process during method development based on IS variation to identify specific patterns which can impact method robustness and mainly data reliability during sample analysis; Be ready to answer Regulatory Agencies’ concerns on IS variation & data accuracy
Specialized Session F-1 - full-day specialized session
Cut-Points Why, When and How? Current industry standards on Cut-Points and Pre-Existing Antibodies Evaluation - Working closely with Regulatory Agencies and experts to define how to handle cut-points in complex situations such as: disease populations with high frequency of pre-Abs, new modalities, vaccines, peptides, ADC, etc. Pitfalls and challenges in the calculation of Screening (SCP) and Confirmatory (CCP) cut-points vs. false positive rates
Training Course F-2 - full-day course
"Large Molecules Bioanalytical Method Development by LCMS, HRMS and Hybrid LBA/LCMS Specifically and Systematically Designed for Scientists with LBA Background" - Discover the Whole Power and Exciting Potential of LCMS in the Bioanalysis of Biotherapeutics
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