Transition to non-animal based vaccine batch release testing. Policy and regulations theoretical aspects and case studies.

Microsoft Teams 12:30-15:45 CET
27th March 2024

The webinar is part of the Humane Society International project “Promoting implementation plans for replacement of animal testing for human vaccines”, a 3-year project aiming to accelerate the implementation and regulatory acceptance of non-animal approaches for legacy human vaccine batch-release testing with a specific focus on developing countries, advancing the dialogue toward global regulatory alignment while generating local implementation plans and competencies.

The webinar explains the theoretical aspects of the transition to non-animal based vaccine batch release testing that have been incorporated in regulations and guidelines and provides key insights and references to representatives of regulatory agencies and public and private testing laboratories, and manufacturers worldwide. The most representatives case studies of animal testing substitution are presented, highlighting the scientific, technical, and data driven rationale for the substitution of the methods, and some of the available mechanisms of dialogue and collaboration between industry and regulatory agencies.

Agenda & Presentation Slides

TopicsSpeakers
Welcome, objectives & short surveyLaura Viviani, SciEthiQ for HSI
Substituting In Vitro for In Vivo Potency and Safety Assays: Science Versus the Fear Factor
30 minutes plus 5 minutes for Q&A
Presentation Slides
Dean Smith, HealthCanada
The VAC2VAC project
10 minutes plus 5 minutes for Q&A
Presentation Slides
Joris Vandeputte, Carmen Jungbäck, IABS
Case study from VAC2VAC: DTP potency
20 minutes plus 5 minutes for Q&A
Presentation Slides
Paul Stickings, MHRA
Case study: Human rabies vaccine potency
30 minutes plus 5 minutes for Q&A
Presentation Slides
Patrice Riou, Sanofi
Eriko Terao, EDQM
The Eur. Ph. strategy for the replacement of the Rabbit Pyrogenicity Test
20 minutes plus 5 minutes for Q&A
Presentation Slides
Emmanuelle Charton, EDQM
NGS for adventitious viruses: ongoing initiatives and upcoming events.
15 minutes plus 5 minutes for Q&A
Presentation Slides
Laurent Mallet, EDQM
Towards the end of in vivo toxicity testing (incl. reference to aP as well)
15 minutes plus 5 minutes for Q&A
Presentation Slides
Svein Rune Andersen, Norwegian Institute of Public Health, chair EDQM WG15
Closing remarks
10 minutes
Laura Viviani, SciEthiQ for HSI

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