• US FDA:

  KEYNOTE: Revisiting Semler - Current Posture of Data Integrity in Bioanalysis?
  Mr. Brian Folian, Deputy Office Director, US FDA

• Health Canada:

  Assessing Internal Standard Response Variation: ICH M10 & Bioavailability Studies at Health Canada
  Dr. Anna Edmison, Senior Clinical Assessment Officer, Health Canada

• US FDA:

  Addressing Challenges in In Vitro Bioequivalence Studies: The Dilemma of Reserve Samples
  Dr. Arindam Dasgupta, Deputy Director, Division of New Drug Study Integrity, US FDA

• UK MHRA:

  New Approaches to Compliance and Inspections
  Mr. Stephen Vinter, Head of Compliance Team , UK MHRA

• US FDA:

  Challenges and Updates in Matrix Evaluation using HPLC/MS-MS in Generic Drug Application
  Dr. Li Yang, Pharmacologist, US FDA

• Brazil ANVISA:

  The Newly Published ANVISA Guideline based on ICH M10 BMV
  Mr. Joao Tavares Neto, Regulation and Health Surveillance Expert, Brazil ANVISA

• Health Canada:

  Navigating Success: Strategies for high quality data in bioequivalence laboratories
  Mr. Reza Salehzadeh-Asl, National Supervisor, Health Canada

• Dutch IGJ / EU EMA:

  Inspections during the COVID-19 Pandemic
  Ms. Sonja Kwadijk-de Gijsel, Senior GCP Inspector, Dutch IGJ / EU EMA

• US FDA:

  Considerations for Data Rejection and Sample Reanalysis in Bioanalytical Analysis in Abbreviated New Drug Applications (ANDAs)
  Dr. Yang Lu, Senior Pharmacologist, US FDA

• UK MHRA:

  UK MHRA Bioanalytical Observations and Findings from Recent Inspections
  Mr. Michael McGuinness, Head of GLP & Laboratories, UK MHRA

• Health Canada:

  Review of Comparative Bioavailability Studies for Chemical Drugs 
  Dr. Dany Ivanova, Clinical Assessment Officer, Health Canada

ASK THE REGULATORS!
Interactive Panel Discussion with the Regulators on Regulated Bioanalysis / BMV

• Regulatory Panelists on Regulated Bioanalysis / BMV
  • Dr. Brian Folian (US FDA)
  • Dr. Julia Cho (US FDA)
  • Dr. Arindam Dasgupta (US FDA)
  • Dr. Kimberly Benson (US FDA)
  • Dr. Yang Lu (US FDA)
  • Dr. Li Yang (US FDA)
  • Dr. Jinhui Zhang (US FDA)
  • Mr. Stephen Vinter (UK MHRA)
  • Mr. Michael McGuiness (UK MHRA)
  • Ms. Emma Whale, (UK MHRA)
  • Ms. Sonja Kwadijk-de Gijsel, (Dutch IGJ / EU EMA)
  • Dr. Anna Edmison (Health Canada)
  • Dr. Dany Ivanova (Health Canada)
  • Ms. Reza Salehzadeh-Asl (Health Canada)
  • Dr. Akiko Ishii-Watabe (Japan MHLW)
  • Mr. Joao Tavares Neto (Brazil ANVISA)
  • Ms. Dulcyane Neiva Mendes (Brazil ANVISA)

• US FDA:

  An Update on the Biomarker Qualification Program (BQP) and Analytical/Clinical Validation 
  Mr. Abbas Bandukwala, Biomarker Qualification Program Science Policy Analyst, US FDA

• Germany PEI / EU EMA:

  Clinical Biomarker and CDx Regulation in EU - Part 1: Regulatory and Analytical Aspects
  Dr. Joerg Engelbergs, Scientific-Regulatory Assessor (Quality, Non-Clinic, Biomarker, CDx), Germany PEI / EU EMA

• Germany PEI / EU EMA:

  Clinical Biomarker and CDx Regulation in EU - Part 2 Scientific and Clinical Aspects
  Dr. Hilke Zander, Clinical Assessor, Germany PEI / EU EMA

• UK MHRA:

  Overview of the UK MHRA International Recognition Procedure (IRP)
  Dr. Shirley Hopper, Deputy Director of Innovative Medicines, UK MHRA

• US FDA:

  Common Errors in Vaccine Biomarker Assays Development: A Regulator's Perspective
  Ms. Leslie Wagner, Consumer Safety Officer, US FDA

• EU EMA:

  Regulatory Perspective on Clinical Vaccine Biomarker Assays Validation and Studies to Support Approval
  Dr. Alessandra Buoninfante, Scientific Officer, EU EMA

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 CDER)
  • Ms. Leslie Wagner (US FDA CBER)
  • Dr. Joshua Xu (US FDA NCTR)
  • Dr. Shirley Hopper (UK MHRA)
  • Dr. Alessandra Buoninfante (EU EMA)
  • Dr. Hilke Zander (Germany PEI / EU EMA)
  • Dr. Joerg Engelbergs (German PEI / EU EMA)