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
Topics | Speakers |
Welcome, objectives & short survey | Laura 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 |