DAY 2

Presentation: In vitro Analytical Characterization based Quality and Potency Assessment of mRNA Vaccines
Moderators: Paul Sticking, MHRA, UK

In vitro Analytical Characterization based Quality and Potency Assesment of mRNA Vaccines
Gautam SANYAL
Vaccine Analytics, USA

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Session 5: Safety Testing: from development to implementation and regulatory acceptance
Moderators: Sarah Sheridan, Merck, UK

Safety tests for vaccines; Strategies to remove and replace animal tests in the European Pharmacopoeia 
Catherine Milne
EDQM, France

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Next Generation Sequencing (NGS)- An alternative to animal based neurovirulence testing (NVT) for polio vaccines
Kutub MAHMOOD
PATH, USA

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Next generation sequencing as an alternative to neurovirulence tests in animals for the quality control of live-attenuated viral vaccines
Javier MARTIN
MHRA, UK

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A cell-based assay for tetanus toxin as an alternative to animal models used in safety testing of tetanus toxoid  
Paul STICKINGS
MHRA, UK & Ciara DORAN, Sheffield University

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TABST/LABST waiver… and more in veterinary vaccines
Laure MARTINEZ
Virbac, France

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How industry is Phasing Out in vivo Safety Testing
Emmanuelle COPPENS
Sanofi, France

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Path To Remove and Replace Safety Testing In India
Pradip DAS
Biological E, India

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Panel discussion
All speakers

Session 6: Roles of global health stakeholders in funding, cost sharing for capital invesment, training and shaping global agendas
Moderators: Joris Vandeputte, IABS, Belgium

Panel Discussion
Dianliang LEI-WHO, Switzerland
Meenu BATOLAR-CEPI, Singapor
Ole OLESEN-Independent Expert, Belgium
Naree KETUSING-WOAH, Thailand

Session 7: Potency Testing: Achievements and next steps for implementation
Moderators: Heidemarie Schindl, AGES, Austria

Potency Testing for Adjuvanted Vaccines: Progress, Roadblocks and a Vision for Non Animal testing
Badiaa BOUZYA
GSK, Belgium (remote)

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Gyrolab-Based In Vitro Immunoassay for Potency and Quality Control of Chikungunya VLP Vaccine: A Sensitive Alternative to Animal Models
Katarzyna OSETEK-MÜLLER
Bavarian Nordic, Germany

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Replacing the in vivo potency test for human rabies vaccines: a global collaborative initiative
Jean-Michel CHAPSAL
Consultant & Project Manager BSP149, France

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From in vivo to in vitro Testing for DTaP (Diphtheria, Tetanus, acellular Pertussis) Potency Testing
Emmanuelle COPPENS
Sanofi, France

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Application of VP2 & VP4 mAb-based Indirect ELISA for Potency and Stability Assessment of Indian Trivalent Vaccine Formulations
Rabindra PRASAD SINGH
ICAR-National Institute on Foot and Mouth Disease, India (remote)

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The next challenge – a fully in vitro approach to ensure quality and consistency of whole-cell pertussis vaccines
Paul STICKINGS
MHRA, UK

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Panel Discussion
Badiaa BOUZYA-GSK, Belgium (remote)
Dieter PULLIRSCH-AGES, Austria
Katarzyna OSETEK-MÜLLER-Bavarian Nordic, Germany
Jean-Michel CHAPSAL-Consultant & Project Manager BSP149, France
Emmanuelle COPPENS-Sanofi, France
Rabindra PRASAD SINGH-ICAR-National Institute on Foot and Mouth Disease, India (remote)
Paul STICKINGS-MHRA, UK

Session 8: Availability of critical reagents and use of reference standards - lesson learnt and open challenges
Moderators: Dean Smith, IABS, Canada

Introduction: Setting the scene on critical reagents
Kutub MAHMOOD, PATH, USA
Paul STICKINGS, MHRA, UK

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Panel Discussion on Critical Reagents
Paul STICKINGS-MHRA, UK
Javier MARTIN, MHRA, UK
Kutub MAHMOOD, PATH, USA
Dianliang LEI, WHO, Switzerland
Mihaela BUDA, EDQM, France

Introduction: Setting the scene on use of reference standards
Dean SMITH 
IABS, Canada

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Panel Discussion on Use of Reference stadards
Paul STICKINGS, MHRA, UK
Javier MARTIN, MHRA, UK
Kutub MAHMOOD, PATH, USA
Dianliang LEI, WHO, Switzerland
Mihaela BUDA, EDQM, France