Drug dis

Global strategy for accelerating the implementation of alternatives methods (3Rs) in the quality control of vaccines and other biologics

  • Chair(s):

    Dr Anthony Holmes
    NC3Rs, United Kingdom

    Dr Mario Landys
    Finlay Vaccines Institute, Cuba

  • Session description:

    The need for 3Rs approaches in biologicals quality control/batch release testing and the impact of global harmonisation – an industry perspective
    Dr Emmanuelle Coppens, Sanofi, France

    Regulatory perspective on the implementation of 3Rs approaches in biologics quality control and batch release testing
    Dr Robin Levis, Food and Drug Administration, FDA, Bethesda, USA

    Avoiding neurovirulence testing through a risk-based approach
    Dr Tong Wu, Health Canada

    Serological approach for replacing a challenge potency test for Tetanus vaccines: a case study
    Dr Pradip Das, Biological E, India

    Review of animal testing requirements in WHO Guidelines and Recommendations for biologicals: a proposal to implement 3Rs principles
    Dr Elliot Lilley, National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), London, United Kingdom

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Date

05 Jul 2023

Time

1:35 pm - 4:00 pm

Speakers

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