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

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Event date and time
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Organiser
NC3Rs
Location
Online
Needle in a vial of vaccine

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

  • Dr Cynthia Allen, Health Canada

Panel discussion

  • Dr Seeven Vydelingum, Sanofi Pasteur Vaccines, Canada
  • TBC, National Institute for Drug and Food Surveillance (INVIMA), Colombia
  • Dr Edith Lavado Perez, Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Peru
  • Dr Octavio Presgrave, INCQS, Brazil
  • Dr Gabriela Solano, Instituto Clodomiro Picardo, Costa Rica
  • Dr Tong Wu, Health Canada, Canada

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

  • Dr Rafael Baptista Silvestrin, Instituto Butantan, Brazil

Panel discussion

  • Dr Juthika Menon, Sanofi Pasteur Vaccines, Canada
  • Dr Edson Sinuhe Torres Ballato, COFEPRIS, Mexico
  • Dr Diana Mesa, National Institute for Drug and Food Surveillance (INVIMA), Colombia
  • Dr Sayuri Reyes Garcia, Agencia Nacional de Regulacion, Control y Vigilancia Sanitaria, Ecuador
  • Dr Gabriel Cabrejos, Centro Nacional de Control de Calidad, Instituto Nacional de Salud, Peru
  • Dr Leslie Wagner, FDA, USA
  • Dr Tong Wu, Health Canada, Canada

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).