"Regulators' Advice on Bioanalytical Method Validation (BMV) and Biomarkers Assay Validation (BAV)"
Session 1: Regulated Bioanalysis/BMV
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US FDA:
OSIS on Remote Regulatory Assessments (RRAs)
Dr. Kara Scheibner, Pharmacologist, US FDA -
US FDA:
Regulatory Findings from Recent Inspections
Dr. Yiyue (Cynthia) Zhang, Senior Staff Fellow, US FDA -
WHO:
Significant Deficiencies during Recent Inspections
Dr. Elham Kossary, Technical officer - Inspector, WHO -
US FDA:
Validation of Matrix Effect following ICH M10 Recommendations
Dr. Yang Lu, Staff Fellow, US FDA -
Health Canada:
Case studies from Health Canada Review
Dr. Anna Edmison, Senior Clinical Assessment Officer, Health Canada -
UK MHRA:
MHRA Inspection Update - Recent Regulatory Findings
Ms. Emma Whale, Senior GCP & GLP Inspector, UK MHRA -
US FDA:
Recent Findings in Method Validation from Bioequivalence (BE) Review
Dr. Li Yang, Pharmacologist , US FDA -
Brazil ANVISA:
ANVISA updates on ICH M10 Implementation
Ms. Dulcyane Neiva Mendes Fernandes , Regulation and Health Surveillance Expert, Brazil ANVISA -
Health Canada:
What Reviewers look at - Problems Encountered During Review
Dr. Dany Ivanova, Clinical Assessment Officer, Health Canada -
UK MHRA:
Data Integrity: Overview of MHRA Implementation of Data Integrity guidance in the UK
Ms. Emma Whale, Senior GCP & GLP Inspector, UK MHRA -
Dutch Youth and Health Inspectorate (IGJ):
An Update on Regulatory Inspections from European Health Authorities
Ms. Sonja Kwadijk-de Gijsel, Senior Inspector, Dutch Youth and Health Inspectorate (IGJ)
ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Regulated Bioanalysis/BMV
- Regulatory Panelists on Regulated Bioanalysis/BMV
- Dr. Sean Kassim (US FDA)
- Dr. Seongeun (Julia) Cho (US FDA)
- Dr. Kimberly Benson (US FDA)
- Dr. Kara Scheibner (US FDA)
- Dr. Yiyue (Cynthia) Zhang (US FDA)
- Dr. Gopa Biswas (US FDA)
- Dr. Mohsen Rajabi Abhari, (US FDA)
- Dr. Yang Lu (US FDA)
- Dr. Li Yang (US FDA)
- Dr. Anna Edmison (Health Canada)
- Dr. Dany Ivanova (Health Canada)
- Ms. Emma Whale, (UK MHRA)
- Ms. Sonja Kwadijk-de Gijsel, (Netherlands IGJ / EU EMA)
- Dr. Akiko Ishii-Watabe (Japan MHLW)
- Ms. Dulcyane Fernandes (Brazil ANVISA)
- Dr. Elham Kossary (WHO)
Session 2: Biomarker & CDx/BAV
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US FDA:
Use of Biomarkers in Drug Development: A Regulatory Perspective
Dr. Mary Thanh Hai, Deputy Director for Clinical, US FDA -
Belgium FAMHP / EU EMA:
Integrated CDx and Pharmaceutical Development in EU Regulatory Landscape
Dr. Olga Kholmanskikh, Clinical assessor, Belgium FAMHP / EU EMA -
US FDA:
Updates from CDRH on IVD Policies
Ms. Tamara Pinkney, Policy Analyst, US FDA -
US FDA:
A Clinical Pharmacology Perspective on Biomarker Assay Validation
Dr. Yow-Ming Wang, Associate Dir Biosimilar & Therapeutic Biologics, US FDA -
US FDA:
Biomarker Assay Validation (BAV) and Qualification Program
Mr. Abbas Bandukwala, Science Policy Analyst, US FDA -
US FDA:
Regulatory Perspective on PD Biomarker Analysis
Dr. Xiulian Du, Senior Science Advisor, US FDA
ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Biomarker & CDx/BAV
- Regulatory Panelists on Biomarker & CDx/BAV
- Dr. Mary Thanh Hai (US FDA CDER)
- Dr. Olga Kholmanskikh (Belgium FAMHP)
- Ms. Tamara Pinkney (US FDA CDRH)
- Dr. Joshua Xu (US FDA NCTR)
- Dr. Yow-Ming Wang (US FDA CDER)
- Mr. Abbas Bandukwala (US FDA CDER)
- Dr. Xiulian Du (US FDA CDER)
- Dr. Yoichi Tanaka (Japan MHLW)
