International Alliance for Biological Standardization
“I hold that a man should strive to the uttermost for his life’s set prize”
Robert Browning (7 May 1812 – 12 December 1889), English poet and playwright.
Upcoming events and News
Diagnostics in the Veterinary Field: The Role in Health Surveillance and Disease Identification
SAVE THE DATE
Diagnostics in the Veterinary Field: The Role in Health Surveillance and Disease Identification
Dorinth Pallas Hotel
Wiesbaden, Germany
15-17 May 2019
Diagnostics are an essential tool to ensure the health of domestic and wild animals for both endemic and emerging diseases. They allow animal health professionals to understand and manage the general health status of domestic animals. They are also important tools to support public health initiatives in the case of zoonotic disease control. The meeting will provide an overview of existing systems and approaches / strategies for the use of diagnostics and to discuss the currently available diagnostics. The advantages / benefits and disadvantages / gaps of the current methods and methodologies will be identified and discussed. Proposals on how to increase the quality, efficacy, and utility of the existing strategies and methods and those under development will be made.
Implementing Nonanimal Approaches to Human and Veterinary Vaccine Testing
REGISTRATION OPEN
Natcher Conference Center
National Institutes of Health
Bethesda, Maryland
October 16-17, 2018
The meeting is co-organized by the National Toxicology Program Interagency Center
for the Evaluation of Alternative Toxicological Methods
NICEATM
and the
International Alliance for Biological Standardization
North America Affiliate (IABS-NA)
More information about the meeting
5th Statistical Approaches for CMC Development and Lifecycle Management of Biotherapeutics and Vaccines
Register Now
5th Statistical Approaches for CMC Development and
Lifecycle Management of Biotherapeutics and Vaccines
November 26-28, 2018
Venue: US Pharmacopeia
Rockville, Maryland
Objectives
This meeting is to bring together regulators and scientists to discuss statistical approaches used to help develop and manage processes, which ensure the quality and availability of biotherapeutics and vaccines. Speakers and panel members will engage with meeting participants on challenges and solutions related to CMC development and lifecycle management of biologics. Areas of attention will include Quality by Design in process and analytical development, comparability and biosimilarity, stability study design and analysis, validation, and continuous process and analytical verification. Statistical challenges related to introduction of new technologies and Big Data will be discussed. Special emphasis will be devoted to collaboration and communication, between scientists and statisticians as well as industry and regulators. The meeting will bring experts together to discuss the issues and through roundtables attempt to reach conclusions that will add value to global public health.
More information about the meeting
Latest news
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IABS Presentation to the U.S. Veterinary Biologics Training Program
In May 2018, an overview of IABS’ mission and activities was presented at the U.S. Veterinary Biologics Training Program. The training program is co-sponsored by the USDA APHIS Center for Veterinary Biologics, the USDA APHIS National Veterinary Services Laboratories and the ISU College of Veterinary Medicine’s Institute for International Cooperation in Animal Biologics (IICAB). The IICAB was founded in 1995 by the USDA Animal and Plant Health Inspection Service and Iowa State University. In June 1998, the IICAB received designation as a component of the World Organization for Animal Health (OIE) Collaborating Centre for the Diagnosis of Animal Diseases and Vaccine Evaluation in the Americas. The designation is shared with the USDA APHIS National Veterinary Services Laboratories (NVSL) and Center for Veterinary Biologics (CVB).
The first Veterinary Biologics Training Program was held in June 1996 at the ISU College of Veterinary Medicine. The training program has been offered each year since then. More than 2600 individuals have attended the program including over 740 international participants from 90 different countries. More than 150 participants attended in 2018. The program is known worldwide as a premier training program in immunology and veterinary vaccines. Many individuals who have participated in the training continue to be actively involved with veterinary biologics issues and activities world-wide.
Training Program participants were keenly interested in IABS and had many questions. Complimentary IABS Membership for 2018-2019 was offered to participants. IABS is looking forward to some of the new members attending upcoming conferences and workshops and becoming more actively involved with our organization.
Respectfully submitted,
Rick Hill, IABS Communication Committee Chair
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Join CASSS for the first CASSS Cell & Gene Therapy Products meeting on July 10-12, 2018 at the Bethesda North Marriott Hotel & Conference Center, Rockville, MD.
We are very pleased to be launching the Symposium this July, continuing CASSS’ commitment to driving science forward and pushing through pre-conceived notions.
Learn more at http://www.casss.org/?page=CGTP1801
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IABS “3R” Conferences Highlighted in Presentation at the 10th World Congress on Alternatives and Animal Use in the Life Sciences.
August 24, 2017, an overview of IABS’ “3R” Conferences, Symposia and Workshops was included in a presentation at the vaccine session at the 10th World Congress on Alternatives and Animal Use in the Life Sciences in Seattle Washington (See Summary Slide below). The World Congress are periodic scientific meetings with emphasis on the latest technologies for reduction and replacement of animals and innovations in approaches to ethics, animal welfare and public policy. Interestingly, the World Congress’ first meeting was in 1993, within one year of the IABS’s first Langen Symposium. The 11th World Congress is scheduled for 2020 in the Netherlands.
In general, World Congress participants were aware of IABS’ leadership in the “3R” and Animal “Alternatives” arena and several inquired about the status of future IABS conferences. The meeting presented an opportunity to discuss IABS overall, but also the organizations strategic priority to host “3R” related meetings by the North American and European Affiliates.
Respectfully submitted,
Rick Hill, IABS Communication Committee Chair
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IABS is pleased to announce a valuable new book written by Board Member Dr. Rebecca Sheets titled Fundamentals of Biologicals Regulation: Vaccines & Biotechnology Medicines. Dec. 2017, published by Elsevier’s imprint Academic Press.
For more information, please see https://www.elsevier.com/books/fundamentals-of-biologicals-regulation/sheets/978-0-12-809290-3
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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.
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…
IABS-EU is officially recognized by French authorities as a nonprofit organization.
You will be hearing more about IABS-EU in the months ahead.
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Contact Info
CH-1204 Geneva
Switzerland