Main Workshop DAY 2B - Discussion Topic List

"Regulators' Advice and Regulators Panel Discussions on Regulated Bioanalysis & BMV"

Regulators' Inputs on Regulated Bioanalysis & BMV

  • EU EMA

    Updates on the Status of the ICH M10 BMV Guideline
    - Drs. Jan Welink, Sr. Clinical Assessor, EU EMA

  • Brazil ANVISA

    Brazil ANVISA ICH Initiatives and Updates Regulation (Revision of Bioequivalence Guideline, BE of Orally Inhaled Drug Products and Dermatological Products)
    - Mr. Gustavo Santos, General Manager of Medicines and Biological Products, Briazil ANVISA

  • US FDA

    Observations from US FDA Inspections and Evaluation of Case Studies
    - Dr. Arindam Dasgupta, Deputy Director of the Division of New Drug Study Integrity, US FDA

  • Health Canada

    Biosimilar Requirements at Health Canada
    - Dr. Catherine Soo, Sr. Clinical Evaluator Clinical Evaluation Division, Health Canada

  • US FDA

    US FDA Regulatory Perspectives on Stability of Biotherapeutics
    - Dr. Sam Haidar, Senior Science Advisor Office of Study Integrity and Surveillance, US FDA

  • Health Canada

    Recent Small Molecules Regulatory Findings from Health Canada: Impact on delays in the reviewing process and negative decisions
    - Dr. Anna Edmison, Senior Clinical Assessment Officer Division of Biopharmaceutics Evaluation, Health Canada

  • US FDA and UK MHRA

    Data Integrity in Bioanalysis – Current Regulatory Perspective

    • From Generic Drug Products at US FDA
      - Dr. Nilufer Tampal, Acting Deputy Director Office of Bioequivalence, US FDA
    • New Regulatory Findings from UK MHRA
      - Mr. Stephen Vinter, Operations Manager GLP Monitoring Authority and Laboratories Group, UK MHRA

Ask the Regulators!
Panel Discussion with the Regulators on Bioanalysis & BMV Guidance

  • Regulatory Panelists on Bioanalysis / BMV:
    • Dr. Tahseen Mirza (US FDA)
    • Dr. Arindam Dasgupta (US FDA)
    • Dr. Sam Haidar (US FDA)
    • Dr. Mohsen Rajabiabhari (US FDA)
    • Dr. Nilufer Tampal (US FDA)
    • Dr. Suman Dandamudi (US FDA)
    • Dr. Patrick Faustino (US FDA)
    • Dr. Diaa Shakleya (US FDA)
    • Dr. Jinhui Zhang (US FDA)
    • Drs. Jan Welink (EU EMA)
    • Mr. Stephen Vinter (UK MHRA)
    • Mr. Michael McGuiness (UK MHRA)
    • Dr. Anna Edmison (Health Canada)
    • Dr. Catherine Soo (Health Canada)
    • Dr. Susan Stojdl (Health Canada)
    • Mr. Gustavo Santos (Brazil ANVISA)