" Regulators' Advice on Bioanalytical Method Validation (BMV) & Biomarkers Assay Validation (BAV) "
Session 1: Regulated Bioanalysis / BMV
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US FDA:
Global Alliance Toward Data Integrity
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Italy AIFA / EU EMA:
New GCP R3, Challenges and Opportunities: Oversight of Clinical Trials and Potential Impact on Bioanalysis
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US FDA:
OSIS Inspectional ObservationsÂ
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Health Canada:
Case Studies from Health Canada Reviews: Bioanalysis of Small Molecule Drugs
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US FDA:
Considerations for Bioanalysis of Liposomal Drugs in BE Studies in ANDAs
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UK MHRA:
Regulatory Update & Specific Case Studies from Recent Inspections
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US FDA:
Analyte Instability Challenges for Bioequivalence (BE) Studies in Generic Drug Applications
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Brazil ANVISA:
Recent Challenges in Pharmacokinetic (PK) Comparative Trials for Large Molecules
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Health Canada:
Critical Considerations in Bioanalytical Data Review
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UK MHRA:
Focus on Data Integrity
ASK THE REGULATORS!
- Have an Open Dialogue with the Regulators including US FDA, UK MHRA, Italy AIFA / EU EMA, Health Canada, Brazil ANVISA
Ask the Regulators any questions you have on Regulated Bioanalysis / BMV, and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes
Session 2: Biomarkers, IVD/CDx and BAV
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US FDA:
Case Studies of Pharmacodynamic (PD) Biomarker Assay Validation – Fit-for-Purpose Considerations
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UK MHRA:
Routes to Market for Medical Devices and IVDs
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US FDA:
An Update on Biomarker Qualification Program
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Belgium FAGG / EU EMA:
Navigating Regulatory Guidance on Biomarkers and Biomarker Assays
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US FDA:
Moving Your Validated Assay: Why you may need a U-haul
ASK THE REGULATORS!
- Have an Open Dialogue with the Regulators including US FDA, UK MHRA, Belgium FAMHP / EU EMA
Ask the Regulators any questions you have on Biomarkers, IVD/CDx and BAV, and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes
