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WHO

Second round of public consultation

Call for comments by 15 March 2016

1. Guidelines on the quality, safety and efficacy of Ebola vaccines

2. Guidelines on Clinical Evaluation of Vaccines: Regulatory Expectations

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Invitation to Join Brighton Collaboration

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International Alliance for Biological Standardization, Coordinated by Dodet Bioscience

The International Alliance for Biological Standardization (IABS), located in Geneva, Switzerland, is a non-profit association recognized as an NGO by WHO. The mission of IABS is to contribute to the scientific and medical advancement of biologicals by facilitating the communication among those who develop, produce and regulate biological products for human and animal health.

29-30 March, 2016 - Bethesda, Maryland PDF Print

 

REGISTRATION NOW OPEN 

 

 

GAIA

 

Global Alignment of

Immunisation Safety Assessment in Pregnancy

 

International Consensus Conference

 

 

REGISTER HERE

 

March 29-30, 2016

National Institutes of Health

Lister Hill Center Auditorium

Bethesda, Maryland, USA

 

Aim

The aim of this conference is to highlight progress in harmonizing safety monitoring of immunization in pregnancy and to develop consensus recommendations for a globally concerted approach.

Objectives

To discuss new safety data from immunization in pregnancy studies

To identify converging stakeholder needs and requirements for high quality data

To review new standards and tools for safety monitoring, including terminology

To build consensus on best practice guidance for monitoring vaccine safety in pregnancy

Outcomes

Shared understanding of the challenges of monitoring immunization in pregnancy

Shared understanding of potential solutions for a collaborative way forward

Consensus on the need for a globally concerted approach

Recommendations for a road map towards optimal safety data based on a globally harmonized approach

 

This conference is inspired by the work performed within the GAIA project by partners and volunteers worldwide. 

This meeting will bring together regulators, scientists, academia and industry experts to help resolve existing challenges of safety monitoring of immunization in pregnancy and to reach conclusions that will be valuable to a globally concerted approach.

 

REGISTER HERE

Provisional Agenda

Learn more about GAIA here

 
28-30 September, 2016 - Budapest, Hungart PDF Print

Save The Date

 

Emerging Diseases in Animals:

Strategies in Surveillance, Control and Eradication

 

Budapest, Hungary

28 - 30 September 2016

 

Co-organized by IABS and

The National Food Chain Safety Office Directorate of Veterinary Medicinal Products, Budapest, Hungary

 

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 coming soon.

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

SAVE THE DATE

 

3rd Statistical and Data Management Approaches for Biotechnology Drug Development

 

October 11-12, 2016

USP Headquarters, Rockville, Maryland

 

Co-organized by IABS and FDA

 

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 soon

 

 
WHO Second round of public consultation and comments PDF Print

 

WHO

Second round of public consultation

Call for comments by 15 March 2016

 

 

Dear colleagues,

 

The following documents have been posted on the WHO biologicals web site http://www.who.int/biologicals/en/ for a second round of public consultation and comments:

 

1. Guidelines on the quality, safety and efficacy of Ebola vaccines

http://www.who.int/biologicals/Ebola_Draft_6_(Ver_5_clean_for_2nd_PC)_25_Jan_2016_TZ.pdf?ua=1

Comment form

 

2. Guidelines on Clinical Evaluation of Vaccines: Regulatory Expectations

http://www.who.int/biologicals/Clinical_guidelines_27_January_2016.pdf?ua=1

Comment form

 

All comments received by the published deadline will be considered in the preparation of the discussion at the next meeting of the Expert Committee on Biological Standardization (ECBS) to be held from 17 to 21 October 2016.

 

Thank you for taking action on this.

 

With best regards,

Ivana

 

Dr Ivana Knezevic

Scientist, Technologies, Standards and Norms Team

Group Lead, Norms and Standards for Biologicals

Department of Essential Medicines and Health Products (EMP)

Health Systems and Innovation (HIS) Cluster

Office: L276

Phone: +41 22 791 3136

Fax: +41 22 791 4971

Email: knezevici@who.int

Biological standardization website: www.who.int/biologicals

Immunization website: www.who.int/immunization

 

Assistant:

Joanna McMahon (Mrs)

Assistant to Group Lead

HIS/EMP/TSN

Tel. direct: +41 22 791 2427

Fax direct: +41 22 791 4167

E-mail: mcmahonj@who.int

 

 
IABS-EU - April 2015 PDF Print

IABS announces the participation of its European affiliate IABS-EU

in the IMI Call

Zoonosis anticipation and preparedness initiative (ZAPI)

 

IABS-EU, the European affiliate of the International Alliance for Biological Standardization (IABS) is pleased to announce its participation in the IMI call “Zoonoses Anticipation and preparedness Initiative (ZAPI)”.

This is the first time that technical platforms have been put in place. Involving different ‘actors’, these platforms will be used in the event of a pandemic or a major health threat.

The results of these technical platforms will serve to develop vaccines and antibodies, thereby allowing for optimal response should a pandemic or major threat of zoonoses occur.

This, however, creates an unforeseen regulatory situation: how to proceed in an emergency situation to ensure that these totally new tools become quickly available?

In order to respond to this question, IABS-EU will become a facilitator in the elaboration of new regulatory processes. To this end, IABS-EU has created a group of experts composed of regulatory agencies and members of the consortium who will identify as quickly as possible the specific issues that must be taken into consideration. Additionally, IABS-EU and its ZAPI partners will strive to avoid any and all regulatory hurdles that could hamper the rapid availability of vaccines and antibodies that have been developed via these new technical platforms.

 
IABS-EU - July 2014 PDF Print

IABS launches its European affiliate: IABS-EU

This is a landmark event in the history of IABS and will open the way for greater participation with EU partners in scientific activities. The objective of the Association IABS-EU is to support the mission and projects of the International Alliance for Biological Standardization and to enhance its image and develop its outreach within the European Union. The Association will contribute to 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 market use.

A unique feature of IABS is that it acts as a neutral meeting point for the major stakeholders - regulators, academia, and industry- to consider the impact of regulatory requirements on innovation, with the objective of identifying sections that may require modification.

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

 

Founding Members :

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IABS has signed an MoU with the following organizations:

Fondation Mérieux

Brighton Collaboration

Learn more about:

 

 

World Organization for Animal Health

http://www.oie.int/en/

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International Alliance for Biological Standardization, Coordinated by Dodet Bioscience