* IABS-EU       * IABS-NA

“It always seems impossible until its done”
Nelson Mandela

Upcoming events and News

28-30 September, 2016 - Budapest, Hungary

 

Registration Open

Emerging Diseases in Animals:
Strategies in Surveillance, Control and Eradication

Budapest, Hungary
28 - 30 September 2016

 

Co-organized by

  • IABS

  • Paul-Ehrlich-Institut

  • Hungarian National Food Chain Safety Office


Budapest, Hungary

REGISTER HERE

 

Emerging animal diseases challenge the health of domestic and wild animals. These highly contagious or transmissible diseases may spread easily, irrespective of political and geographic borders. This spread is fostered by the increased global movement of domestic animals and food produced from animals, as well as by vectors such as man, wild animals, intermediate hosts, and contaminated materials of all kind. This spread is also influenced by other factors such as changes in climate.

Outbreaks of diseases in livestock have a negative impact on economies, individuals’ livelihood and quality of life, as well as global safety of food produced by animals.

Although there is permanent progress in the development of new vaccines against a wide range of diseases, emerging infections and transboundary spread pose specific challenges in terms of surveillance and prophylactic interventions.

The goal of this meeting, to be held in 2016, is to update current experience in the identification, tracking, and control of these animal diseases. This includes experience thus far with licensing of vaccines required for emergency situations or scenarios. An additional area of discussion will focus on fostering rapid availability of vaccines.

More information and registration here.

11-12 October, 2016 - USP, Rockille, Maryland

 

Registration Open

3rd Statistical and Data Management Approaches
for Biotechnology Drug Development

USP Headquarters, Rockville, Maryland
October 11-12, 2016

Co-organized by IABS and FDA

REGISTER HERE

 

The 3rd annual stats & data management meeting will bring together regulators, and scientists, or those interested in statistics from academia and industry, who have a background in statistics, to continue exploring how best to resolving existing challenges in ensuring the quality of biotechnology medicinal products and to bring high quality medicines to patients. Guidance on how to use statistics for a variety of activities required during biotechnology product development such as method development, improvement and replacement, product comparability, biosimilarity exercises and stability program development will be provided by the speakers and panel members. In addition, the complexity of the types of data and the volume being analysed is ever increasing and how best to manage such data will be discussed. The meeting will bring the right experts together to discuss the issues and through roundtables attempt to reach conclusions that will be valuable globally to public health.

 

More information and registration here.

November 2-3, 2016 - London, United Kingdom

 

Registration Open

CELL THERAPY 2016

November 2-3, 2016
The Wellcome Collection
London, United Kingdom

REGISTER HERE

 

The 2016 Cell Therapy conference will identify the key issues to be addressed for the manufacture of cell therapies and provide scientific consensus on selected aspects to inform the drafting of future guidance. The meeting will bring together representatives from industry, academia, health services and regulatory bodies.

It is intended that the conference output should provide core elements that will be useful in establishing international consensus on the requirements for manufacture of cell based medicines and enable progress towards a potential future WHO endorsed guidance.

 

More information and registration here.

21-22 March, 2017 - Geneva, Switzerland

Save The Date

Future Development and Scientific Considerations of Biotechnology Reference Standards

co-organized by IABS and IFPMA March 21-22, 2017
Centre International de Conférences Geneva, Switzerland

 

Goal and outcomes of the meeting

The goal of the meeting is to discuss the current relevance and scientific utility of biological reference standards in the development of biotechnology products, biosimilars and biological assays. Biological reference standards can take the form of in-house manufacturer’s standards, World Health International Standards, NIBSC reference reagents, Pharmacopoeia standards and other public standards such as NIST standards. The ways in which these material are used, how they are calibrated and the use of any associated unitages will be discussed. The scientific and regulatory considerations for the creation and use of these materials will also be included.

More information coming soon

2nd Human Challenge Trials Conference - Rockville, Maryland

Save The Date

2nd Human Challenge Trials Workshop
US Pharmacopeia - Rockville, Maryland
March 15-17, 2017

Our world needs safer, more effective drugs and vaccines to prevent and treat infectious diseases.  Controlled human infections (CHIs) have served as an effective tool to promote this objective. For example, CHIs have led to progress in developing interventions against respiratory pathogens, enteric pathogens, and parasites. The most frequent application is the conduct of human challenge trials (HCTs), which can safely assess the value of novel or improved drugs and vaccines much more rapidly and efficiently than field trials, particularly if efficacy against CHI bridges to the field.  Progress against an infectious threat is greatly hampered when the field lacks a supporting human challenge model, such as is the case for human immunodeficiency virus and Mycobacterium tuberculosis.

Based on the premise that optimal use of CHIs is one of the best, most efficient ways to achieve rapid progress against infectious diseases, IABS is hosting a workshop to review the use of HCTs to promote the development of new drugs and vaccines, the benefits and risks of this approach, the regulatory framework within which HCTs are conducted, and novel CHI applications that would open new translational pathways.  This workshop follows two and a half years after the first such workshop hosted by IABS in Strasbourg, France, September 2014.

More information about this work coming soon.

In Brief

  • A few words from the President

    On June 3 2016, the presidency of IABS was passed over to me in agreement with the IABS election process.
    Above all, I thank John Petricciani for his exceptional leadership and wise advice.
    Read more

  • IABS Communication Committee

    Recognizing the need for improving the communication process, the IABS Board of Directors established a Communication Committee at the June 2016 Board meeting in Lyon, France. 

    Learn more here

  • 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

  • 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

  • Harmonized Safety Monitoring of Immunization in Pregnancy

    The important Harmonized Safety Monitoring of Immunization in Pregnancy International Consensus Conference was recently held at the NIH in Bethesda, Maryland and highlighted progress to date in harmonizing safety monitoring of immunization in pregnancy.

    Learn more about the Harmonized Safety Monitoring of Immunization in Pregnancy ICC here

  • Scientific Committees

    IABS scientific activities are the responsibility of the Scientific Conference Committees, representing special interests within the fields of Human Biologicals and Veterinary Biologicals.
    The Scientific Conference Committees are responsible for the organization of scientific conferences.

    Human Vaccine Committee
    Chairpersons:

    Human Cell & Gene Therapy Committee
    Chairperson: Takao Hayakawa (Japan)

    Human Biotherapeutics Committee
    Chairperson: Anthony Mire-Sluis (USA)

    Veterinary Biologicals Committee
    Chairperson: Carmen Jungbäck (Germany)


    Please find all the biosketches in the Documents section

  • MoU

    IABS has signed an MoU with the following organization:

    Fondation Mérieux

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Latest news

  • Vac2Vac

    New website is online

    We are pleased to inform you that the VAC2VAC website is online now.

    You can access the site using the following link: www.vac2vac.eu.

    Read more at www.vac2vac.eu .

  • IABS-NA

    IABS Launches its North American Affiliate: IABS-NA

    This is another landmark event in the history of lABS, and will open the way for greater participation on scientific activities with partners in Canada, Mexico, and the USA. The objectives of IABS-NA are to support the mission and projects of IABS, to enhance its image, and to develop an outreach within North America. IABS-NA will contribute to the scientific and medical advancement of biologicals by facilitating communication among those who develop, produce and regulate biological products for human and animal health. More specifically, it will focus on issues concerning the regulation and standardization of biological products that are intended for marketing within this region. As a neutral meeting point for the major stakeholders - regulators, academia, and industry- IABS-NA will consider the impact of regulatory requirements on innovation, with the objective of identifying issues that may require further consideration and possible modification.

    Discussions are already underway regarding a conference topic that will meet that objective, and that will complement and enhance IABS-EU activities.

    IABS-NA is officially recognized by USA authorities as a charitable organization [501(c)(3) designation].  

    Read More
  • ZAPI

    IABS-EU leads regulatory work package in the IMI Call Zoonosis Anticipation and Preparedness Initiative (ZAPI)

    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.

    This, however, creates an unforeseen regulatory situation: how to proceed in an emergency situation?

    In order to respond to this question, IABS-EU has become a facilitator in the elaboration of new regulatory processes. It has created a group of experts composed of regulatory agencies and members of the consortium to address specific issues in emergency situations to ensure that these new tools become quickly available.

    ZAPI is a 5 years collaborative partnership between more than 20 European partners, including leading human and veterinary research institutions, non-governmental organizations, regulatory agencies, expert academic groups, and vaccine and biotech manufacturers. With more than 22 million euros in funding, ZAPI is the first true “One Health” project within the scope of IMI and unites experts in animal health and human health.


  • Gaia

    Harmonized Safety Monitoring of Immunization in Pregnancy

    The important Harmonized Safety Monitoring of Immunization in Pregnancy International Consensus Conference was recently held at the NIH in Bethesda, Maryland and highlighted progress to date in harmonizing safety monitoring of immunization in pregnancy.

    Learn more about the GAIA conference by visiting:
    IABS Past Conferences


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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 :

Read more:

International Alliance for Biological Standardization


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Contact Info

IABS, Route des Jeunes 9
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CH-1227
Switzerland
+ 41 22 301 10 36
+ 41 22 301 10 37
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