Specialized Workshop F1 - Friday April 11, 2025: 7am to 5:30pm
" AGENDA -
Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting
- Latest Advances, Challenges and Solutions from Internationally Recognized Key Opinion Leaders "
| 07:00am-08:00am: |
Start your day at WRIB with Continental Breakfast |
Session 1: Current Crucial Challenges with ICH M10 Implementation and Interpretation
Session 2: Ensuring Data Integrity in Automated Biospecimen Management and ELN Migration
Special Session: ASK THE REGULATORS! Interactive Panel Discussion with All the Regulators
| -07:40pm: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Bioanalysis/BMV
Regulatory Panelists:
- Dr. Brian Folian (US FDA)
- Dr. Julia Cho (US FDA)
- Dr. Arindam Dasgupta (US FDA)
- Dr. Kimberly Benson (US FDA)
- Dr. Yang Lu (US FDA)
- Dr. Li Yang (US FDA)
- Dr. Jinhui Zhang (US FDA)
- Mr. Stephen Vinter (UK MHRA)
- Mr. Michael McGuiness (UK MHRA)
- Ms. Emma Whale, (UK MHRA)
- Ms. Sonja Kwadijk-de Gijsel, (Dutch IGJ / EU EMA)
- Dr. Anna Edmison (Health Canada)
- Dr. Dany Ivanova (Health Canada)
- Ms. Reza Salehzadeh-Asl (Health Canada)
- Mr. Joao Tavares Neto (Brazil ANVISA)
- Ms. Dulcyane Neiva Mendes (Brazil ANVISA)
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Session 3: FFP Validation for Automated Methods, Three Way-Cross Validation and Urine Analysis
Session 4: ICH M10 Regulatory Queries: Protein Binding, Micro/Patient-Centric Sampling and Hybrid Assays (IA-MS)
Session 5: 2025 White Paper in Bioanalysis
| 07:40pm-08:40pm: |
"Recommendations on BMV and Regulated Bioanalysis and Panel Discussions for 2025 White Paper in Bioanalysis"
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