15th WRIB

15^th WRIB (Workshop on Recent Issues in Bioanalysis) – Where Regulators and Industry Convene – Sep. 27-Oct. 1, 2021, Orlando Disney Springs, FL, USA

Bioanalysis, Biomarkers, Immunogenicity, Gene Therapy, Cell Therapy and Vaccines – Each year WRIB program provides you with novel case studies and emerging approaches because it is the ONLY program built on White Paper recommendations/consensus from the previous years to ensure no repetitions of same discussions but a continuous evolution of science, regulations and technology applications.

Although WRIB is planned as an in-person meeting, in case you are not able to travel, you also have the option to attend remotely with 15% reduced registration fee – simply because you are missing all the fun and face to face interactions at an in-person meeting. Moreover, you will be able to Switch between the two attendance options if your travel situation changes before the meeting.

Participating Regulators at the 15^th WRIB will again include all Major and Influential Regulatory Agencies in North America, Europe, Latin America, and Asia – Ask your Questions and Interact Directly with Regulators!

Specialized Workshops at the 15^th WRIB:

• M-1: “ADA/NAb Guidance Day: Recent Advancements in the Harmonization of Immunogenicity Testing & Reporting”
• M-2: “BMV Guidance Day: Recent Issues in Bioanalytical Method Validation Guidances and Regulated Bioanalysis for Small and Large Molecules”
• T-1: “Mass Spectrometry of Biotherapeutics, Protein Biomarkers and Transgene Proteins: from Discovery to Regulatory Submissions”
• Th-1: “Conventional & Novel Critical Reagents: Recent Issues in Development and Management for Established/Emerging Technologies/Modalities”
• Th-2: “Cytometry Innovation Day: Novel Techniques & Advanced Approaches in Cytometry”
• F-1: “Biomarkers Development & Translational Science: Recent Issues from Discovery to Regulatory BAV Guidance”
• F-2: “Gene Therapy, Cell Therapy and Vaccine Bioanalysis: Recent Issues in Scientific Advancements and Regulations”

15^th WRIB will continue the 3-Day Sequential Main Workshop Program featuring Method Development and Regulatory Challenges:

• Mass Spectrometry: LCMS, Hybrid Assays (IA-MS) and HRMS
• Ligand-binding, Flow Cytometry and qPCR Assays
• Application of Multiple Technologies to solve Complex Bioanalytical Issues
• Regulators’ Inputs and “Ask the Regulators” Panel Discussions

As always, High quality, better compliance to regulations and scientific excellence are the foundation of WRIB. Come with your questions and go back with the solutions!