Specialized Workshop F1 - Friday April 17, 2026: 7am to 5pm
"AGENDA - Regulated Bioanalysis Sampling, Validating, Analyzing & Reporting
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| 07:00am-08:00am: |
Start your day at WRIB with Continental Breakfast |
Session 1: What's the Future of Bioanalytical LIMS?
Session 2: Beyond ICH M10 - What's next in Regulated Bioanalysis? LMD, AI/ML and Robotics/Automation
Special Session: ASK THE REGULATORS!
| -07:40pm: |
Regulatory Feedbacks on Submitted Studies and Inspection/Audit Outcomes on Bioanalysis/BMV
Regulatory Panelists:
- Dr. Seongeun (Julia) Cho (US FDA)
- Dr. Arindam Dasgupta (US FDA)
- Dr. Nilufer Tampal (US FDA)
- Dr. Yang Lu (US FDA)
- Dr. Li Yang (US FDA)
- Dr. Kui Yang (US FDA)
- Dr. Jinhui Zhang (US FDA)
- Dr. Diaa Shakleya (US FDA)
- Ms. Emma Whale (UK MHRA)
- Ms. Anne-Marie Massip (UK MHRA)
- Mr. Fabrizio Galliccia (Italy AIFA / EU EMA)
- Dr. Anna Edmison (Health Canada)
- Dr. Dany Ivanova (Health Canada)
- Dr. Christine Dobson (Health Canada)
- Mr. Joao Tavares Neto (Brazil ANVISA)
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Session 3: Fit-for-Purpose BMV for Very Low Sample size and Very High Target Interference
Session 4: Limitations of ICH M10
Session 5: 2026 White Paper in Bioanalysis
| 07:40pm-08:20pm: |
"Recommendations on BMV and Regulated Bioanalysis and Panel Discussions for 2026 White Paper in Bioanalysis"
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