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NC3Rs | 20 Years: Pioneering Better Science
Online

NC3Rs workshop: Implementing the 3Rs in WHO guidelines – understanding the impact on quality control and batch release testing of biologicals in Europe

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NC3Rs

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 currently running a survey to gather information on how the 3Rs are implemented in quality control, batch and lot release testing of biologicals. Find out more on our project page: Review of animal use requirements in WHO biologics guidelines

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 Europe and has been developed with the support of experts from the region (see 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. 

We are grateful for the support of the organising committee in developing this workshop: 

  • Dr Martijn Bruysters, National Institute for Public Health and the Environment (RIVM), The Netherlands 

  • Dr Emmanuelle Coppens, Sanofi, France 

  • Mr Simeon Gill, Medicines and Healthcare products Regulatory Agency (MHRA), UK 

  • Dr Sylvie Morgeaux, The National Agency for the Safety of Medicines and Health Products (ANSM), France 

  • Dr Volker Öppling, Paul-Ehrlich-Institut, Germany  

  • Dr Paul Stickings, National Institute for Biological Standards and Control (NIBSC), UK 

Other workshops are being planned to cover North/Central America, Latin/South America, Africa, and Asia/Oceania. 

The workshop is free to attend, but registration is essential. 

Register now via Zoom