Upcoming IABS-EU events and News

November 13-14, 2019 - Het Pand, University of Ghent, Belgium

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Registration Is Open!

2nd Next Generation Sequencing
for Adventitious Virus Detection

Meeting objectives
T
his meeting will focus on the current scientific data and knowledge related to the use of next generation sequencing technologies for adventitious virus detection in biological products. Discussions will include ongoing efforts and future needs toward standardization and validation of the technical and bioinformatics steps involved in NGS for its applications in characterization and safety evaluation of biologics, including human and animal vaccines. The meeting will bring together representatives from industry, academia, technology providers, and international regulatory bodies for developing a scientific consensus regarding readiness of NGS for detection of adventitious viruses in biologics.

Scientific Committee

Dieter Deforce, Ghent University / Federal Agency for Medicines and Health Products of Belgium (FAMHP)
Sebastiaan Theuns, Ghent University
Arifa Khan, U.S. Food and Drug Administration (FDA)
Pieter Neels, International Alliance for Biological Standardization (IABS)
Sven Arnouts, Ghent University / PROVAXS
Johannes Blümel, Paul-Ehrlich Institut (PEI)
Bill Egan, Novartis Vaccines & Diagnostics
Carmen Jungbäck, International Alliance for Biological Standardization (IABS)
Ivana Knezevic, World Heath Organization (WHO)
Laurent Mallet, Sanofi Pasteur
Gerald Schumann, Paul-Ehrlich Institut (PEI)
Joseph Victoria, Boehringer-Ingelheim

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 More information about this IABS-EU meeting coming soon...

October 22, 2019 - Paul-Ehrlich-Institut, Langen, Germany

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Quality of Challenge Agent
An IABS-EU Meeting

Meeting Objectives
One of the proposed tools for faster development of new vaccines is CHIM: Controlled Human Infectious Models. These models can be used for early PoC (Proof of Concept) and as a basis for clinical  “Go/No Go” decisions, in particular if sporadic epidemiology impedes clinical development.
In these models researchers will use a challenge agent: a virus, bacterium or parasite. Frequently questions are raised on the quality of the agent. Should this agent be produced following GMP? What strain-related information is relevant?  Should it be attentuated or resemble the wild type?

These questions will be discussed during this symposium, more information will follow soon

 

 

IABS EU Projects

 IABS Europe Projects

 

 

Zoonoses Anticipation and Preparedness Initiative (ZAPI) - http://www.zapi-imi.eu The Zoonoses Anticipation and Preparedness Initiative (ZAPI), part of the Innovative Medicines Initiative (IMI) public-private partnership, aims to enable swift response to major new infectious disease threats in Europe and throughout the world by designing new manufacturing processes (up to large scale) for delivering effective control tools (vaccines, antibodies/antibody-like molecules) against (re-)emerging zoonotic diseases with pandemic potential within a few months after the occurrence of first cases

 

 

http://www.vac2vac.eu/    VAC2VAC is a wide-ranging collaborative research project funded by IMI2 which aims to develop and validate quality testing approaches for both human and veterinary vaccines using non-animal methods.   http://www.bprc.nl/download/BPRC_VAC2VAC.pdf

IABS-EU Heads Work Package in new IMI project: VAC2VAC

VAV2VAC is a wide-ranging collaborative research project funded by IMI2 which aims to develop and validate quality testing approaches for both human and veterinary vaccines using non-animal methods. The initiative that started on 1 March 2016 aims to provide the data to support the "Consistency Approach" for quality control of established vaccines, where current quality control approaches are often relying on in vivo methods.

VAC2VAC is a public-private consortium of twenty partners, involving experts from veterinary and human vaccine industry in a partnership with official medicines control laboratories, academia, translational research organisations, and vaccinology alliances. To achieve their goal, the project partners will develop, optimise and evaluate physico-chemical and immunochemical methods, cell-based and other assays for routine batch quality, safety and efficacy testing of vaccines. This will be done in collaboration and consultation with regulatory agencies. The ultimate goal of the project is to develop tests and approaches that will allow acceptance of the "Consistency Approach" for established vaccines by the regulatory agencies and thereby significantly reducing in the future the use of animals for batch testing in routine vaccine production.

Learn More

Press Release…

ZAPI

About ZAPI - The new Zoonoses Anticipation and Preparedness Initiative (ZAPI), part of the Innovative Medicines Initiative (IMI) public-private partnership, aims to enable swift response to major new infectious disease threats in Europe and throughout the world by designing new manufacturing processes (up to large scale) for delivering effective control tools (vaccines, antibodies/antibody-like molecules) against (re-)emerging zoonotic diseases with pandemic potential within a few months after the occurrence of first cases…

Learn more

 


IABS-EU is officially recognized by French authorities as a nonprofit organization.

You will be hearing more about IABS-EU in the months ahead.

Founding Members :

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International Alliance for Biological Standardization


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