DAY 1

Opening remarks
Joris Vandeputte-IABS, Belgium
Sarawut Boonsuk-Ministry of public Health, Thailand
Laura Viviani-HWA and AFSA

Opening Lecture: Importance of investments in Asia and Thailand for vaccine R&D, state of the art quality testing and regulatory harmonization. Ongoing initiatives and opportunities to consider.
Nakorn Premsri
National Vaccine Institute of Thailand

Slide

Session 1: OneHealth approach to advance vaccine control strategies
Moderators: Catherine Milne, EDQM, France

One Health drives for New Approach Methodologies (NAMs) approaches for Vaccine Batch release
Catrina STIRLING
Zoetis (remote), UK

Slide

Panel discussion
Pradip DAS-Biological E, India
Lorenzo TESOLIN-Sciensano, Belgium
Corinne PHILIPPE-Boehringer Ingelheim, France
Dean SMITH-IABS, Canada

Session 2: Industry perspective on phasing in non-animal testing and efforts to promote global alignment 
Moderators: Laura Viviani, SciEthiQ, Italy

Animal Testing Replacement: Global Human Vaccine Manufacturer Perspectives
Emmanuelle COPPENS
Sanofi, France

Slide

Implementation of non-animal testing and efforts to promote global alignment - An Industry Perspective
Sunil GOEL
Serum Institute of India, India

Slide

Implementing non-animal testing
Corinne PHILIPPE
Boehringer Ingelheim/HealthforAnimals, France

Slide

Panel discussion
Emmanuelle COPPENS - Sanofi, France
Sunil GOEL-Serum Institute of India, India
Corinne PHILIPPE-Boehringer Ingelheim/HealthforAnimals, France

Session 3: Regulatory perspective - Ongoing progress in methods acceptance
Moderators: Henk-Jan Ormel, Dutch Competent Authority for Animal Procedures, Netherlands

Brief Introduction of WHO Guidelines on the replacement or removal of animal tests for the quality control of biological products
Dianliang LEI 
WHO, Switzerland

Slide

EDQM’s support for the 3Rs – status update and insights into Ph. Eur. General Chapter 5.2.14
Mihaela BUDA
EDQM, France

Slide

VICH concept paper on principles for technical guidance for the transition to in-vitro methods for batch potency tests in veterinary immunologicals
Kota SATO
National Veterinary Assay Laboratory, Japan

Slide

Indian Pharmacopoeia perspectives on alternatives to animal methods in testing of vaccines for human and animal use
Muthusamy KALAIVANI
Indian Pharmacopeia Commission, India

Slide

Implementation of 3Rs to quality control of biologicals and lot release tests in Japan
Masaaki IWAKI
JIHS (Japan Institute for Health Security), Japan

Slide

ANVISA's regulatory perspectives on progress in alternative method acceptance
Evelin BALBINO
ANVISA, Brazil

Slide

Korea's Strategy for NAMs Adoption: Harmonizing Regulatory Science and Innovation
In-Sook PARK
Korea Regulatory Science Centre, South Korea

Slide

Advancing 3rs implementation:badan pom strategy for animal testing replacement in vaccine quality control
Fitra DELVIONA
BADAN POM, Indonesia

Slide

Workshop: How to build competence in new testing strategies in National Control Laboratories?
Moderators: Dean Smith, IABS, Canada, & Janette Turner, Humane World for Animals, UK

How to build competence in new testing strategies in National Control Laboratories? - A WHO perspective
Alexandrine MAES (remotely) 
Alan FAUCONNIER, WHO, Switzerland

Slide

Building competence in new testing strategies in National Control Laboratories
Sunil GOEL
Serum Institute of India, India

Slide

 EU OMCL network experience contributes to method implementation and reduced animal use
 Catherine MILNE
EDQM, France

Slide

How to Build NCL Competences? A Case Study from the Belgian National Control Laboratory
Lorenzo TESOLIN
Sciensano, Belgium

Slide

Building Competence in Non-Animal Testing Strategies for Vaccine Quality Control
Luca PORFIRI
FAO, Thailand

Slide

Session 4: A new pyrogenicity. How MAT and recombinant BET are changing the approach to pyrogenicity
Moderators: Juliana Gutierrez, bioMérieux, Japan

An EDQM update on pyrogenicity in European Pharmacopoeia
Mihaela BUDA
EDQM, France

Slide

Bacterial Endotoxin Testing:  Progressive Science and Sustainability
Jay BOLDEN
Eli Lilly & Company, USA

Slide

Transition from LAL test for endotoxin to rFC methods
Corinne PHILIPPE
Boehringer Ingelheim/HealthforAnimals, France

Slide

Navigating the Transition: Regulatory and Practical Perspectives on Implementing the Monocyte Activation Test
Bernhard ILLES
Microcoat, Germany

Slide

Advancing 3Rs in Quality Control of Immunobiologicals: Butantan’s Strategy for Implementing MAT and Recombinant Endotoxin Testing
Juliana GALVÃO DA SILVA
Fundação Butantan, Brazil

Slide

How Industry is Implementing in vitro Alternatives for Pyrogenicity testing
Emmanuelle COPPENS
Sanofi, France

Slide

Waive and Replace the Rabbit Pyrogen Test in Lifecycle Vaccine Release
Shahjahan SHAID
GSK (remote), Germany

Slide

Panel Discussion
Mihaela BUDA-EDQM, France
Jay BOLDEN-Eli Lilly & Company, USA
Corinne PHILIPPE-Boehringer Ingelheim/HealthforAnimals, France
Bernhard ILLES-Microcoat, Germany
Juliana GALVÃO DA SILVA-Fundação Butantan, Brazil
Emmanuelle COPPENS-Sanofi, France
Shahjahan SHAID-GSK (remote), Germany