Agenda at a Glance

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Agenda of the Whole Week

The 13th WRIB will continue to feature the novel and unique 3-Day Sequential Program during the Main Workshop Days with no parallel sessions. However you have the flexibility to choose which Workshop Days based on your specific track of interest and learning needs.

In addition to the Sequential Main Workshop Days, 6 full-day Training Courses/Specialized Sessions will spread throughout the week to give you many choices to combine Main Workshop Days with Training Courses/Specialized Sessions to maximize your learning process at any level in your field of expertise.

Monday April 1, 2019

  • Full Day Training Sessions (7am - 5:30pm):

    • Training Session M-1:

      "New Insights in Biomarkers Assays Validation (BAV): From Regulated Bioanalytical Method Validation (BMV) Guidance to Fit-for Purpose Validation"A journey of the Biomarker community across platforms, regulations and industry standards: Current Status

    • Training Session M-2:

      "Recent Advancements in Biotherapeutics Bioanalysis by LCMS, HRMS and Hybrid LBA/LCMS"Expanding your Experience in Biotherapeutics Bioanalysis by Learning the Potential of LCMS as complementary technique to LBA

  • *Please note that M-1 and M-2 are in parallel from 7am to 5:30pm.

Tuesday April 2, 2019

  • MAIN WORKSHOP DAY 1 (7am to 6pm):

    • Main Workshop Day 1A:

      "LCMS, HRMS and Hybrid: Innovation in Method Development and Novel Solutions in Drug Discovery/Development"

    • Main Workshop Day 1B:

      "ICH M10 BMV Draft Guideline - Chromatography: Industry/Regulators’ Perspectives - Working together to provide official Recommendations to ICH for the Chromatography portion of the document"

  • Full Day Training Session (7am to 5:30pm):

    • Training Session T-1 for LBA scientists:

      "Critical Reagents & Flow Cytometry: Recent Advancements and New Frontiers for the Bioanalytical Lab" - In a fast-paced environment the need to catch up with current industry standards, regulations and emerging approaches in both Critical Reagents & Flow Cytometry is crucial for Pharma & CRO

  • *Please note that Main Workshop Day 1 and Training Session T-1 are in parallel from 7am to 6pm.

Wednesday April 3, 2019

  • MAIN WORKSHOP DAY 2 (7am to 6pm):

    • Main Workshop Day 2A

      "LBA & LCMS: Orthogonality/Complementarity - PK, Biomarkers and Immunogenicity Assays"

    • Main Workshop Day 2B

      "ICH M10 Common Topics Chromatography & LBA: Industry/Regulators’ Perspective – Working together to provide official Recommendations to ICH for the LBA & Chromatography portion of the document"

    • Main Workshop Day 2C

      "Regulators’ Advice - Immunogenicity Final Guidance and Biomarker Papers: Latest Regulators’ Inputs & Asking your Questions and Interacting Directly with Regulators"

    • Main Workshop Day 2D

      "Regulators’ Advice - Bioanalysis, BMV Guidance/Guidelines: Latest Regulators’ Inputs & Asking your Questions and Interacting Directly with Regulators"

  • *Please note that Day 2A, 2B, 2C and 2D are consecutive, NOT in parallel.

Thursday April 4, 2019

  • MAIN WORKSHOP DAY 3 (7am to 6pm):

    • Main Workshop Day 3A

      "LBA, Cell-based Assays/Flow Cytometry, and Emerging Technologies for Biomarkers & Immunogenicity: Innovation in Method Development and Novel Solutions in Drug Discovery/Development"

    • Main Workshop Day 3B

      "ICH M10 BMV Draft Guideline - LBA: Industry/Regulators’ Perspective – Working together to provide official Recommendations to ICH for the LBA portion of the document"

  • Full Day Training Session (7am to 5:30pm):

    • Training Session Th-1 for LCMS scientists:

      "Regulatory inputs & Industry experiences on Implementing the 2018 FDA BMV Final Guidance: Lessons Learnt from Case Studies in Small Molecules" - The latest updates for companies involved in Regulated Bioanalysis

  • *Please note that Main Workshop Day 3 and Training Session Th-1 are in parallel from 7am to 6pm.

Friday April 5, 2019

  • Full Day Training Sessions (7am - 5:30pm):

    • Training Session F-1:

      Cut Points - “The Evolution”: Issues in statistical evaluation of Cut Points and impact on Immunogenicity Assay development" - Building on Industry/Regulators’ recommendations & Working together for harmonization

    • Training Session F-2:

      "The Gene Therapy challenge: what you need to know and how it is impacting Bioanalysis in both Pharma and CRO"Multiple platforms & multiple approaches to deal with unsolved bioanalytical issues

  • *Please note that Training Session F-1 and F-2 are in parallel from 7am to 5:30pm.

Agenda in Charts according to your Focus

 

 

Full Immersion Agenda Chart

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LCMS Focus Agenda Chart

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LBA Focus Agenda Chart

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