Registration Details
The NC3Rs is working with the World Health Organization (WHO) to review animal testing requirements within their guidelines for the quality control and batch release testing of biologicals. Co-funded by the Bill and Melinda Gates Foundation, the aim is to identify opportunities for the wider integration of 3Rs approaches and recommend these for implementation by WHO through the Expert Committee on Biological Standardization (ECBS). The project has been approved by WHO and ECBS (TRS1024, Section 2.2.2, page 8).
We are hosting a series of regional workshops to better understand the potential impact of these changes on manufacturers and regulators globally. The output from these workshops will inform the recommendations we make to WHO and reduce the barriers for their implementation by ECBS.
This workshop focuses on Asia and has been developed with the support of experts from the region (see below). During the workshop biologicals regulatory agencies and manufacturers from across the region will discuss their perspectives on current testing strategies and how changes to WHO guidelines could be implemented to support wider adoption of 3Rs and non-animal approaches. The draft meeting agenda can be found below.
We encourage participation of biologicals manufacturers, regulators, and relevant other stakeholders from across the region to share their perspectives on the challenges and opportunities presented by wider application of 3Rs approaches within quality control and batch release testing. Although the discussions are focused on Asia, we welcome participation in the workshop from relevant stakeholders globally.
We are grateful for the support of the organising committee in developing this workshop:
- Dr Pradip Das, Biological E, India
- Dr Masaaki Iwaki, National Institute of Infectious Diseases, Japan
- Dr M Kalaivani, Indian Pharmacopoeia Commission, India
- Dr Zebun Nahar, Incepta Vaccine, Bangladesh
- Dr Supaporn Phumiamorn, Institute of Biological Products, Ministry of Public Health, Thailand
- Dr Jack Xie, Janssen, China
- Dr Aya Zamoto-Niikura, National Institute of Infectious Diseases, Japan
Other workshops are planned to cover Pan-America, Africa, and Europe.
The workshop is free to attend, but registration is essential. Please register using your Institutional email address.
Register now via Zoom
Draft Agenda
| Time | Agenda Item |
|---|---|
| 7.00 - 7.05 |
Welcome and introduction Dr Ian Ragan, Chair of the NC3Rs working group to review animal use requirements in WHO biologics guidelines |
| 7.05 - 7.15 |
Aims and objectives for the meeting Professor Yeowon Sohn, Seoul National University, Republic of Korea and member of the WHO Expert Committee on Biological Standardization |
|
Session 1 |
Scene setting |
| 7.15 - 7.30 |
Project overview: Reviewing animal use requirements in WHO guidelines and opportunities for 3Rs approaches Dr Elliot Lilley, NC3Rs |
| 7.30 - 7.50 |
Collaborating across the region on advancing 3Rs methods Dr Laura Viviani, Developing Countries Vaccine Manufacturers Network (DCVMN) |
|
7.50 - 8.00 |
Break |
|
Session 2 |
How aligned are we across the region? |
|
8.00 - 8.50 |
National perspectives on non-animal approaches for quality control and batch release testing of biologicals and the influence of WHO guidelines
|
|
8.50 - 9.20 |
Manufacturers perspectives on the adoption of non-animal approaches in quality control & batch release testing of biologicals
|
|
9.20 - 9.50 |
Break |
|
Session 3 |
Panel Session |
|
9.50 - 10.00 |
Introduction to the session and voting instructions |
|
10.00 - 11.00 |
Panel discussion Moderator: (TBC) Panellists:
The panel discussion will include opportunities for delegates to ask questions of the panel and to respond directly to questions themselves using an interactive voting system. |
|
11.00 - 11.10 |
Wrap up and meeting close |
Certificates of attendance are available on request.