" Regulators' Advice on Bioanalytical Method Validation (BMV) and Biomarkers Assay Validation (BAV) "
Session 1: Regulated Bioanalysis / BMV
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US FDA:
An update on the 2024 Guidance on Handing and Retention of BA and BE testing Samples & Collaboration and Information Sharing with other Agencies
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Health Canada:
Application of ICH M10: Health Canada Review of Comparative Bioavailability Studies
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US FDA:
An update on the New Data Integrity Draft Guidance
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UK MHRA:
Current Data Integrity Issues
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US FDA:
Data Integrity and Data Quality Issues in BA/BE Studies – Understanding FDA's Data Integrity Guidance and Expectations.
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Health Canada:
Case Studies from Health Canada Review: Comparative Bioavailability Studies for Chemical Drugs
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US FDA:
Validation of Recovery in Chromatographic Bioanalytical Method
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UK MHRA:
Bioanalytical Observations and Findings from Recent Inspections
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US FDA:
Regulatory Assessments for Internal Standard in Generic Drug Product Applications
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Brazil ANVISA:
Update on Large Molecule Bioanalysis in Brazil
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Italy AIFA:
Regulated Bioanalysis Impact in Clinical Research
ASK THE REGULATORS!
- Have an Open Dialogue with the Regulators including US FDA, UK MHRA, Health Canada and 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:
A Regulatory Update on Biomarker Qualification Program (BQP) & Biomarker Assay Validation (BAV)
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Belgium FAMHP:
Biomarkers in Oncology: A Regulatory Perspective
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US FDA:
Assay Comparability – A Regulators Perspective
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EU EMA:
Regulatory Developments in Vaccines Approval Landscape
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US FDA:
NGS and PCR Validation & Applications in Biomarker Development
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US FDA:
Use of NGS Technologies on Clinical Applications: A view from Regulatory Science
ASK THE REGULATORS!
- Have an Open Dialogue with the Regulators including US FDA (CDER, CBER, NCTR), EU EMA, UK MHRA and Belgium FAGG
Ask the Regulators any questions you have on Biomarkers, IVD/CDx and BAV, and Hear Their Feedbacks on Submitted Studies and Inspections/Audits Outcomes
