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


Objective: this webinar aims to present the theoretical aspects of the transition to non-animal based vaccine batch release testing that have been incorporated in regulations and guidelines and provide key insights and references to regulators and assessor. The most representatives case studies of animal testing substitution will be presented highlighting some of the available mechanisms of dialogue and collaboration between industry and regulatory agencies.

Draft Agenda

51. Welcome and objectivesLaura Viviani, SciEthiQ for HSI
20 + 5mins Q&A2. Substitution of in vivo method(s) by in vitro method(s) for the quality control of vaccines – key principle of the Eur. Ph. Chapter 5.2.14Dean Smith, HealthCanada
10 +5mins Q&A3. The VAC2VAC projectJoris Vandeputte, Carmen Jungbäck, IABS
20 +5mins Q&A4. VAC2VAC case study – DTP potencyPaul Stickings, MHRA
20 +5mins Q&A5. Case study: aP – Replacement of HISTTBD
30 +5mins Q&A6. Case study: Rabies – potencyEriko Terao (EDQM), Patrice Riou (Sanofi)
20 +5mins Q&A7. The Eur. Ph. strategy for the replacement of the Rabbit Pyrogenicity TestEmmanuelle Charton, EDQM
10 +5mins Q&A8. NGS for Adventitious viruses. Key resources for regulatory approach to NGS.Laurent Mallet, EDQM
10 +5mins Q&A9. Towards the end of toxicity testingSvein Rune Andersen (chair EDQM WG15)
510. Closing remarksRobin Levis, US FDA

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