* 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.

Letter from WHO 07/2016

Dear colleagues,

 

We would like to inform you that a public consultation on several documents for the WHO Expert Committee on Biological Standardization (ECBS) is now open. 

 

Based on WHO consultations with regulators, manufacturers and other experts the following documents were prepared and have been posted on the WHO biologicals web site http://www.who.int/biologicals/en/

for public comments:

 

  1. BS 2279 – Guidelines on the quality, safety and efficacy of Ebola vaccines (proposed new guidelines)

http://www.who.int/biologicals/Ebola_Guidelines_BS.2016_2279_TZ_5_July_2016.pdf?ua=1

Comment form:   pdf Guidelines on the quality, safety and efficacy of Ebola vaccines (175 KB)

Comments should be sent to the Responsible Officer: Dr Tiequn Zhou at email: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

  1. BS 2280 – Labelling information of inactivated influenza vaccines for use in pregnant women

http://www.who.int/biologicals/BS2280_MI_Flu_LINE_NOs_14_July_2016.pdf?ua=1

Comment form:   pdf Labelling information of inactivated influenza vaccines for use in pregnant women: WHO/BS/2016.2280 (21 KB)

Comments should be sent to the Responsible Officer:  Dr Hye-Na Kang at email: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

  1. BS 2287 –  Guidelines on clinical evaluation of vaccines: regulatory expectations

http://www.who.int/biologicals/BS2287_Clinical_guidelines_final_LINE_NOs_20_July_2016.pdf?ua=1

Comment form:   pdf Guidelines on clinical evaluation of vaccines: regulatory expectations (BS2016.2287) (275 KB)

Comments should be sent to the Responsible Officer: Dr Ivana Knezevic at email: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

  1. BS 2289 -  Guidelines on regulatory preparedness for licensing human pandemic influenza vaccines in non-vaccine-producing countries

http://www.who.int/biologicals/BS2289_PIP_non-producer_guide_LINE_NOs.pdf?ua=1

Comment form:   pdf Guidelines on regulatory preparedness for licensing human pandemic influenza vaccines in non-vaccine-producing countries (BS2016.2289) (29 KB)

Comments should be sent to the Responsible Officer: Dr Dianliang Lei at email: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

  1. BS 2290 – Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs)

http://www.who.int/biologicals/BS2290_mAb-SBP_DB_Kai_LINE_NOs_20_July_2016.pdf?ua=1

Comment form:   pdf Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) WHO/BS/2016.2290 (15 KB)

 

We would be grateful if you could provide feedback in your capacity as a member of the Expert Advisory Panel on Biological Standardization and other relevant Panels.  Also, please share this information with your colleagues who may be interested in the topics mentioned above.

All comments received by published deadlines on the website will be considered in the preparation of the discussion at the ECBS meeting to be held from 17 to 21 October 2016. 

Thank you.

With best regards,

Ivana

 

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

  • 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

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Latest news

  • 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

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. IABS-EU heads the Work Package on Regulatory issues - - WP 6 - - in this project.

Press Release…


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
Les Acacias-Geneva
CH-1227
Switzerland
+ 41 22 301 10 36
+ 41 22 301 10 37
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