" 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 & OSIS Inspectional Observations
Mr. Brian Folian, Deputy Office Director, US FDA -
Italy AIFA / EU EMA:
New GCP R3, Challenges and Opportunities: Oversight of Clinical Trials and Potential Impact on Bioanalysis
Dr. Fabrizio Galliccia, Head of GCP Inspectorate and GCP Senior Inspector, Italy AIFA / EU EMA -
Health Canada:
Case Studies from Health Canada Reviews: Bioanalysis of Small Molecule Drugs
Dr. Dany Ivanova, Senior Scientific Evaluator, Health Canada -
US FDA:
Considerations for Bioanalysis of Liposomal Drugs in BE Studies in ANDAs
Dr. Yang Lu, Senior Staff Fellow, US FDA -
UK MHRA:
Regulatory Update & Specific Case Studies from Recent Inspections
Ms. Emma Whale, Senior GCP & GLP Inspector, UK MHRA -
US FDA:
Analyte Instability Challenges for Bioequivalence (BE) Studies in Generic Drug Applications
Dr. Li Yang, Pharmacologist, US FDA -
Brazil ANVISA:
Recent Challenges in Pharmacokinetic (PK) Comparative Trials for Large Molecules
Mr. Joao Tavares Neto , Regulatory Specialist, Brazil ANVISA -
Health Canada:
Critical Considerations in Bioanalytical Data Review
Dr. Helen Renaud, Scientific Evaluator, Health Canada -
UK MHRA:
Focus on Data Integrity
Ms. Anne-Marie Massip, GLP and GCP Inspector, UK MHRA -
US FDA:
Reanalysis of Plasma Samples Collected from CRO Investigating Data Integrity Issue: Addressing Known and Unknown Variables
Dr. Jinhui Zhang, Senior Pharmaceutical Scientist, US FDA
ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Regulated Bioanalysis / BMV
- Regulatory Panelists on Regulated Bioanalysis / BMV
- Mr. Brian Folian (US FDA)
- Dr. Yang Lu (US FDA)
- Dr. Li Yang (US FDA)
- Dr. Yow-Ming Wang (US FDA)
- Dr. Xiulian Du (US FDA)
- Dr. Diaa Shakleya (US FDA)
- Dr. Jinhui Zhang (US FDA)
- Ms. Emma Whale (UK MHRA)
- Ms. Anne-Marie Massip (UK MHRA)
- Dr. Fabrizio Galliccia (Italy AIFA / EU EMA)
- Dr. Anna Edmison (Health Canada)
- Dr. Dany Ivanova (Health Canada)
- Dr. Helen Renaud (Health Canada)
- Mr. Joao Tavares Neto (Brazil ANVISA)
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
Dr. Xiulian Du, Senior Science Advisor, US FDA -
UK Medicines and Health products Regulatory Agency:
Routes to Market for Medical Devices and IVDs
Dr. Annie Truong, Diagnostic Regulatory Specialist, UK Medicines and Health products Regulatory Agency -
US FDA:
An Update on Biomarker Qualification Program
Mr. Abbas Bandukwala, Science Policy Analyst, US FDA -
Belgium FAMHP / EU EMA:
Navigating Regulatory Guidance on Biomarkers and Biomarker Assays
Dr. Olga Kholmanskikh, Clinical assessor, Belgium FAMHP / EU EMA -
US FDA:
Moving Your Validated Assay: Why you may need a U-haul
Ms. Leslie Wagner, Consumer Safety Officer, US FDA
ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Biomarkers, IVD/CDx and BAV
- Regulatory Panelists on Biomarkers, IVD/CDx and BAV
- Mr. Abbas Bandukwala (US FDA)
- Dr. Xiulian Du (US FDA)
- Ms. Leslie Wagner (US FDA)
- Dr. Surender Khurana (US FDA)
- Dr. Joshua Xu (US FDA)
- Dr. Shirley Hopper (UK MHRA)
- Dr. Anna Nowocin (UK MHRA)
- Dr. Olga Kholmanskikh (Belgium FAMHP / EU EMA)
- Dr. Ingrid Schellens (Dutch MEB / EU EMA)
- Dr. Chad Irwin (Health Canada)
- Dr. Huixin Lu (Health Canada)
- Dr. Annie Truong (UK Medicines and Health products Regulatory Agency)
