* IABS-EU       * IABS-NA

“No question is so difficult to answer as that to which the answer is obvious.”
G.B. Shaw (1856-1950)

Upcoming events and News

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 workshop coming soon.

26-27 October, 2017 - USP, Rockville, Maryland

SAVE THE DATE

Next Generation Sequencing
USP Pharmacopeia, Rockville, Maryland
October 26-27, 2017

 

In  October 2017, IABS will organize in close collaboration with regulatory bodies and industry a Next-Generation Sequencing (NGS) conference. This conference will discuss current perspectives on NGS for adventitious virus detection in biologics with focus on applications for viral vaccines, including human and animal vaccines. The meeting will bring together representatives from industry, academia, service providers, and regulatory bodies for developing a scientific consensus regarding applications of NGS for virus detection in biologics. 

 

 More information about this conference 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.

    Press release

    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

  • Emerging infectious diseases of animals

    Slides from Budapest workshop now posted in Past Conferences or folder here

  • New WHO Letter October 2016

    The new Letter from WHO (October 2016) is now available in the WHO section or here.

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Latest news

  • Vac2Vac

    New website is online

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

    Press release: http://www.bprc.nl/download/BPRC_VAC2VAC.pdf

    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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