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 Pan-America 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.
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 Pan-America, 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 Cynthia Allen, Health Canada, Canada
-
Dr Dave Allen, Integrated Laboratory Systems, USA
-
Dr Maria Baca-Estrada, Health Canada, Canada
-
Dr Wlamir Correa, ANVISA, Brazil
-
Dr Eduardo Estrada, Sanofi, Mexico
-
Mr Murilo Freitas, PAHO, USA
-
Dr Robin Levis, FDA, USA
-
Dr Mariluz Pombo, PAHO, USA
-
Dr Octavio Presgrave, INCQS, Brazil
-
Dr Dean Smith, Health Canada, Canada
The draft meeting agenda is below (subject to change):
| Time | Agenda Item |
|---|---|
| 13.00 – 13.05 |
Welcome and introductions Dr Ian Ragan, Chair of the NC3Rs working group to review animal use requirements in WHO biologics guidelines |
| 13.05 – 13.15 |
Opening address Dr Mario Landys, Instituto Finlay de Vacunas, Cuba |
|
Scene Setting |
|
| 13.15 – 13.45 |
Project overview: Reviewing animal use requirements in WHO guidelines and opportunities for 3Rs approaches Dr Elliot Lilley, NC3Rs |
| 13.45 – 14.05 |
Opportunities and challenges for advancing 3Rs methods throughout Pan-America Dr Maria Baca Estrada, Health Canada, Canada |
| 14.05 – 14.30 |
Regulatory acceptance of non-animal approaches to replace in vivo assays for quality control and batch release testing of biologicals: science versus the fear factor Dr Dean Smith, Associate Director, Centre for Biologics Evaluation, Health Canada, Canada |
| 14.30 – 14.45 | BREAK |
| 14.45 – 15.10 |
How does (dis-)harmonisation in acceptance of 3Rs/non-animal approaches for quality control and batch release testing of biologicals impact manufacturers in the region? Dr Emmanuelle Coppens & Dr Philippe Juvin, Sanofi and on behalf of IFPMA |
|
Opportunities and challenges in specific assays/products |
|
| 15.10 – 16.00 |
Panel 1 – Pyrogen/endotoxin testing Scene setting introduction & moderator
Panel discussion
Wrap up – Dr Cynthia Allen |
| 16.00 – 16.10 | BREAK |
| 16.10 – 17.10 |
Panel 2 – Animal based potency and safety assays – a focus on DTap/DTP products Scene setting introduction & moderator
Panel discussion
Wrap up – Dr Rafael Baptista Silvestrin |
|
Perspectives from a national pharmacopeia |
|
|
17.10 – 17.35 |
Integrating 3Rs approaches in the Mexican Pharmacopeia and opportunities to support harmonization throughout Pan-America MSc Angélica López Sotelo, Coordinator of Experts of the Biological Products Committee, Mexican Pharmacopeia |
|
17.35 – 17.40 |
Wrap up and meeting close Dr Ian Ragan |
Previous regional workshops have covered Europe and Asia and can be viewed here. The next workshop will cover Africa (details to follow).