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
Min
Topic
Speaker
5
1. Welcome and objectives
Laura Viviani, SciEthiQ for HSI
20 + 5mins Q&A
2. Substitution of in vivo method(s) by in vitro method(s) for the quality control of vaccines – key principle of the Eur. Ph. Chapter 5.2.14
Dean Smith, HealthCanada
10 +5mins Q&A
3. The VAC2VAC project
Joris Vandeputte, Carmen Jungbäck, IABS
20 +5mins Q&A
4. VAC2VAC case study – DTP potency
Paul Stickings, MHRA
20 +5mins Q&A
5. Case study: aP – Replacement of HIST
TBD
30 +5mins Q&A
6. Case study: Rabies – potency
Eriko Terao (EDQM), Patrice Riou (Sanofi)
20 +5mins Q&A
7. The Eur. Ph. strategy for the replacement of the Rabbit Pyrogenicity Test
Emmanuelle Charton, EDQM
10 +5mins Q&A
8. NGS for Adventitious viruses. Key resources for regulatory approach to NGS.
Laurent Mallet, EDQM
10 +5mins Q&A
9. Towards the end of toxicity testing
Svein Rune Andersen (chair EDQM WG15)
5
10. Closing remarks
Robin Levis, US FDA