Global strategy for accelerating the implementation of alternatives methods (3Rs) in the quality control of vaccines and other biologics
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Chair(s):
Dr Anthony Holmes
NC3Rs, United KingdomDr 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, FranceRegulatory perspective on the implementation of 3Rs approaches in biologics quality control and batch release testing
Dr Robin Levis
Food and Drug Administration, FDA, Bethesda, United States of AmericaAvoiding neurovirulence testing through a risk-based approach
Dr Tong Wu
Health Centre, CanadaSerological approach for replacing a challenge potency test for Tetanus vaccines: a case study
Dr Pradip Das
Biological E, IndiaReview 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
Speakers
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Dr Elliot LilleyNational Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), London, United Kingdom
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Dr Emmanuelle CoppensSanofi, France
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Dr Pradip DasBiological E, India
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Dr Robin LevisDoctor, Food and Drug Administration, FDA, Bethesda, USA
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Dr Tong WuHealth Canada, Canada