Registration Details
At the culmination of a three-year project to promote harmonised integration of the 3Rs in the World Health Organization (WHO) guidelines for quality control and batch release testing of vaccines and biological therapeutics, we are organising a final international stakeholder meeting in London. This two-day symposium will take place on 19–20 September in central London as a hybrid event with live streaming.
This project sought to identify animal tests that are currently recommended for batch release testing of biologicals and to propose revisions to promote the use of more scientifically robust 3Rs approaches wherever possible, for implementation by WHO through the Expert Committee on Biological Standardization.
Registration
The meeting is free to attend, but registration is essential. We welcome participants from all over the world to better inform the wider community of the recommendations, the rationale for their making and to support future global harmonisation in the adoption of 3Rs approaches.
Participants joining remotely will be able to watch all presentations and pose questions. However, we encourage you to attend in-person, where possible, to take advantage of the excellent networking opportunities. Please note that there are limited places available for the in-person event.
For online registrants, certificates of attendance are available on request only to registered participants attending through their unique Zoom link.
Programme
Day 1: Tuesday 19 September, 9.00 – 18.00
Opening address
- Dr Ian Ragan (NC3Rs)
Background to the project and overview of the review process and recommendations
- Dr Richard Isbrucker (Health Canada)
- Dr Elliot Lilley (NC3Rs)
Session 1: Pyrogenicity and Endotoxin testing
- Dr Caroline Vipond (MHRA)
- Dr Emmanuelle Charton (EDQM)
- Dr Shahjahan Shaid (GSK)
- Dr Thierry Bonnevay (Sanofi)
- Dr M. Kalaivani (Indian Pharmacopoeia Commission)
Session 2: Neurovirulence testing
- Dr Emmanuelle Coppens (Sanofi)
- Dr Javier Martin (MHRA)
- Dr Robin Levis (CBER, FDA)
Session 3: Adventitious Agents
- Dr Robin Levis (CBER, FDA)
- Dr Sarah Sheridan (Merck)
- Dr Arifa Khan (CBER, FDA)
- Dr Laurent Mallet (EDQM)
Plenary: The history of animal use and 3Rs in vaccine production and quality control
- Professor Coenraad Hendriksen (Utrecht university)
Day 2: Wednesday 20 September, 9.00 – 15.45
Opening address
- Dr Ian Ragan (NC3Rs)
Session 4: Potency and Immunogenicity testing
- Dr Wlamir Moura (INCQS FIOCRUZ)
- Dr Richard Isbrucker (Health Canada)
- Dr Eriko Terao (EDQM)
- Dr Masaaki Iwaki (NIID Japan)
- Dr Pradip Das (Biological E)
- Dr Le Sun (Antibody China)
Session 5: Specific Toxicity testing
- Dr Paul Stickings (MHRA)
- Dr Richard Isbrucker (Health Canada)
- Dr Pradip Das (Biological E)
- Dr Heike Behrensdorf-Nicol (Paul-Ehrlich-Institut)
- Dr Emmanuelle Coppens (Sanofi)
A review of reference standards in batch release testing of biologicals
- Speakers TBC
Panel discussion
- Dr Ivana Knezevic (WHO Norms and Standards for Biologicals)
- TBC (Bill and Melinda Gates Foundation)
- Dr Laurent Mallet (EDQM)
- Dr Shahjahan Shaid (GSK)
- Dr Emmanuelle Coppens (Sanofi)
- Dr Robin Levis (CBER, FDA)
Each session will introduce the recommended revisions to current, relevant WHO guidance, summarising the 3Rs approaches being proposed. Discussions will be led by experts, manufacturing and regulatory representatives, and each session will include a panel discussion on the recommendations and their potential barriers to uptake.
This event is supported by funding from the Bill and Melinda Gates Foundation.