6th IABS Statistics Workshop:
Approaches for Improving Statistical Partnership in CMC Development,
Manufacturing, and Regulation of Biologicals

U.S. Pharrmacopeia
Rockville, Maryland

Due to restrictions associated with the SARS-COVID-2 pandemic, the 6th IABS Statistics Workshop
originally scheduled November 23-24 at USP Headquarters in Rockville, MD
will be held virtually on the same dates.  Preliminary program information is available
on the IABS website and registration updates will be posted as soon as available


Information about the Meeting

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Cross learning experience human and animal vaccine licensure
based on technology platforms

A Joint CEPI / IABS-EU Workshop

Registration and information about the Meeting



The difficult situation we are facing currently in Europe
and the uncertainties concerning the evolution

of the Covid-19 pandemic
has led us to once again postpone
the CEPI / IABS-EU Workshop. 

The NEW date is now December 1-2, 2020
at the Académie Royale des Sciences.


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Maintaining the quality of vaccines through the use of references standards
Current challenges and future opportunities

Library & Archives Canada
Ottawa, Canada

Registration and information about the Meeting

September 9-10, 2020


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Autogenous Vaccines:
Quality of production and movement in a common market

Ludwig Maximilian University of Munich

registration and information about the meeting

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5th IABS Cell Therapy Conference
Towards international convergence of basic technical requirements
and evaluation of human cell therapy products

Muromachi Mitsui Hall & Conference
Tokyo, Japan

Organized by: International Alliance for Biological Standardization (IABS)
With the support from: Osaka University Graduate School of Medicine

Registration and information about the meeting


Workshop: Implementing Non-animal Approaches to Human and Veterinary Vaccine Testing:

Achieving Scientific and Regulatory Success for Rabies and Beyond

October 16-17, 2018
National Institutes of Health, Bethesda, Maryland



The workshop agenda as well as speaker and poster abstracts are included in the e-book. The e-book and speaker slides are posted on the web (e-book* and slides**).

Quality Requirements for Challenge Agents
An IABS-EU Meeting


  Information about the meeting here


 New paths for sustainable solutions to tackle global and emerging infectious threats


IABS celebrated its 65th Anniversary on February 26-28, 2020, in Lyon, France.


4th Cell Therapy Conference
Manufacturing and Testing of Pluripotent Stem Cells

   Organized by
The International Alliance for Biological Standardization
with support from and in collaboration with the
California Institute for Regenerative Medicine
Los Angeles, Cal
June 5-6, 2018



Objectives and Expected Outcomes

The 2018 Cell Therapy conference will identify key unresolved issues that need to be addressed for the manufacture and testing of pluripotent stem cell-based therapies and provide scientific consensus on selected aspects to inform the drafting of future national and international guidance. The meeting will bring together representatives from industry, academia, health services and regulatory bodies.

The overall goal of the conference is to provide the target audience with an appreciation of the importance of a well-controlled manufacturing process for cell therapies that are in development, and to highlight specific areas that should be considered during early product development in order to avoid issues in later stages. The target audience includes those individuals and organizations actively pursuing research and development of cell therapies with the intent of achieving pluripotent stem cell therapy products that meets regulatory requirements for approval, thus becoming generally available to treat patients with unmet medical needs. 

We will build on previous meetings that generally addressed broader themes of cell therapy studies and manufacturing issues. In addition to reviewing information on the state-of-the-art and recently generated data, this conference ill drill down to key practical issues facing cell therapy developers and regulators to expedite the safe and efficient introduction of new treatments for important diseases where unmet medical needs exist.

More specifically, the conference is expected to provide a basis for new and/or additional guidance on regulatory expectations for developing acceptable pluripotent cell therapy products including testing requirements during manufacture. Concrete conclusions and recommendations will be important outcomes, which are expected to stimulate the field to move forward in a transparent and coordinated manner.

2nd Setting Specifications for Biological Products: A Pathway to Harmonization

Information about the meeting here

4th Statistical and Data Management Approaches
for Biotechnology Drug Development

Venue: USP Pharmacopeia, Rockville, Maryland
October 30 - November 1, 2017


This meeting is to bring together regulators, and scientists, or those interested in statistics from academia and industry, who have a background in statistics, to help resolve 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.

Click here to  learn more about the meeting


3rd Human Challenge Trials in Vaccine Development

Registration for this meeting is closed

Information about the meeting



This meeting provided an important update on the
Regulation and Standardization of Cell Therapies

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


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.

  folder Slides are available here


5th Statistical Approaches for CMC Development and
Lifecycle Management of Biotherapeutics and Vaccines

  November 26-28, 2018
Venue: US Pharmacopeia
Rockville, Maryland


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.


Animal Testing for Vaccines
Implementing Replacement, Reduction and Refinement:

Challenges and Priorities

Information about the meeting here

View the Speaker Slides

Next Generation Sequencing for
Adventitious Virus Detection in Biologics

Venue: USP Pharmacopeia, Rockville, Maryland
October 26-27, 2017



The 2017 NGS conference will discuss current perspectives on NGS for adventitious virus detection in biologics with focus on applications for human vaccines and lessons learnt from veterinary vaccines. The meeting will include data presentations and discussions for developing a scientific consensus to draft points for consideration for using NGS for virus detection in selected applications of biologics.  The meeting will bring together representatives from industry, academia, service providers, and regulatory bodies.




2nd Conference on Next Generation Sequencing
for Adventitious Virus Detection in
Human and Veterinary Biologics

An IABS-EU Meeting

Information about the meeting here

2nd Human Challenge Trials Conference

Venue: Hilton Hotel, Rockville, Maryland
September 28-30, 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.



Narcolepsy and Pandemic Influenza Vaccination
What we know and what we need to know before the next Pandemic

 March 26-27, 2018
Eurostation II, Place Victor Horta
Brussels, Belgium

In partnership with
Federal Agency for Medicines and Health Products (FAMHP)
Vaccine Center of Excellence

This meeting will be held under Chatham House Rule


Influenza Pandemics occur when an influenza strain circulates that humans have not been exposed to before. This may lead to widespread circulation and a high case fatality rate.

In 2009 pandemic, several H1N1 vaccines were developed against the new H1N1 virus and were extensively used. In Finland and Sweden an increase in narcolepsy was noted after the mass vaccination with one of these vaccines.  Disparate results were seen in other countries with other vaccines.  In addition, an increase of narcolepsy has been reported in countries in Asia following wild type influenza infection.

The goal of this meeting is to be prepared for the next pandemic:

  • What are the latest data on the risk of narcolepsy following exposure to 2009 pandemic vaccines?
  • What scientific data are available and what data are lacking to explain the phenomena that was seen in 2009-10?
  • What additional work is needed to prepare for potential use of adjuvanted vaccines for a future pandemic ?  

 View the Agenda   

Towards Rabies Elimination in Asia-Pacific – From Theory to Practice


Meeting objectives
The meeting aims at snowballing efforts and achieving substantial progress in rabies control in the Asia-Pacific region of the world in the near future. As the key focus is placed on canine rabies the meeting will be an important contribution to the initiative of the United Against Rabies collaboration of the World Health Organization (WHO), World Organisation for Animal Health (OIE), Food and Agriculture Organization of the United Nations (FAO), and Global Alliance for Rabies Control (GARC) of ending human dog-mediated rabies by 2030. Recognized international and local experts will give insights into state-of-the art intersectoral One Health approaches, standards, available tools and guidelines developed by international organizations and institutions and best-practice examples from the region on how to prevent human rabies by eliminating rabies at its animal source. As such the meeting provides a platform for health and veterinary services, managers of national and local rabies eliminations programs, researchers and other people interested in advancing knowledge of rabies surveillance, prevention and control, to meet each other, to share their experience and also to discuss challenges to overcome. The meeting is considered to be a starting point for a continuous professional exchange on the way to a rabies free Asia-Pacific.

Scientific Committee :

Dr Charung Muangchana Director, National Veterinary Institute, Thailand
Dr Karoon Chanachai, Department of Livestock Development (DLD), Thailand
Dr Thomas Müller, Chair Friedrich-Loeffler-Institut, Germany
Dr Conrad Freuling, Friedrich-Loeffler-Institut, Germany
Dr Bernadette Abela-Ridder, World Healandh Organization
Dr Ivana Knezevic, World Health Organization
Dr Gregorio Torres, World Organization for Animal Health (OIE)
Dr Katinka de Balogh, Food and Agricultural Organization of the UN (FAO)
Dr Carmen Jungbäck, International Alliance for Biological Standardization (IABS)
Dr Gowri Yale, Mission Rabies
Prof. Louis Nel,Global Alliance for Rabies Control
Dr Ryan Wallace, Centres for Disease Control and Prevention, USA


International Alliance for Biological Standardization

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IABS, Rue de la Vallée, 3
CH-1204 Geneva

+ 41 22 301 10 36
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