International Alliance for Biological Standardization2-5 November, 2020 - VIRTUAL MEETING
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 will be held virtually.
Meeting rescheduled - New Date December 1-2, 2020 - Académie Royale des Sciences, Brussels, Belgium
Cross learning experience human and animal vaccine licensure
based on technology platforms
A Joint CEPI / IABS-EU Workshop
Registration and information about the Meeting
MEETING RESCHEDULED
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.
Meeting rescheduled - New Date - June 8-9, 2021, Ottawa, Canada
Maintaining the quality of vaccines through the use of references standards
Current challenges and future opportunities
Due to the uncertainties concerning the evolution
of the Covid-19 pandemic, the meeting is once again rescheduled
and will now take place on
June 8-9, 2021
Registration and information about the meeting
Read more: Meeting rescheduled - New Date - June 8-9, 2021, Ottawa, Canada
Meeting rescheduled NEW DATE_March 16-18, 2021 - Munich, Germany
Autogenous Vaccines:
Quality of production and movement in a common market
Ludwig Maximilian University of Munich
registration and information about the meeting
Read more: Meeting rescheduled NEW DATE_March 16-18, 2021 - Munich, Germany
IABS Webinar SARS-CoV-2 - May 27, 2020
IABS Webinar
Update on SARS-CoV-2
May 27th, 2020 : 14:00 CEST
IABS has been asked to organize several webinars in order to share scientific information on SARS-CoV-2.
As science is evolving day after day, it is important for many people to have an overview of the actual knowledge at a specific moment in time.
The first IABS webinar that took place Wednesday May 27th from 14:00-16:00 CEST gave you an insight to what is known about SARS-CoV-2, the epidemiology worldwide, the disease from an immunology viewpoint and where we are today with the development of vaccines against the virus.
This webinar is the first in a series of webinars to inform our network on what is known about the virus, the disease, and how to cope with it.
The recording of the webinar is available below:
February 4 - 5, 2020 - Tokyo, Japan
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
Implementing Nonanimal Approaches to Human and Veterinary Vaccine Testing
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**).
Read more: Implementing Nonanimal Approaches to Human and Veterinary Vaccine Testing
October 22, 2019 - Paul-Ehrlich-Institut, Langen, Germany
Quality Requirements for Challenge Agents
An IABS-EU Meeting
Information about the meeting here
Read more: October 22, 2019 - Paul-Ehrlich-Institut, Langen, Germany
February 26-28, 2020 - IABS To Celebrate 65th Anniversary with a Conference about infectious diseases
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
4th Cell Therapy Conference
Manufacturing and Testing of Pluripotent Stem Cells
Organized by
The International Alliance for Biological Standardization
IABS
with support from and in collaboration with the
California Institute for Regenerative Medicine
CIRM
Los Angeles, California
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.
December 2-3, 2019 - Rockville, Maryland
2nd Setting Specifications for Biological Products: A Pathway to Harmonization
4th Statistical and Data Management Approaches for Biotechnology Drug Development
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
February 6-7, 2020 - Pembroke College - Oxford, United Kingdom
3rd Human Challenge Trials in Vaccine Development
Registration for this meeting is closed
November 2-3, 2016 - London, United Kingdom
3rd IABS CONFERENCE on CELL THERAPY
MANUFACTURING AND TESTING
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
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.
December 3-4, 2019 - Bangkok, Thailand
Animal Testing for Vaccines
Implementing Replacement, Reduction and Refinement:
Challenges and Priorities
Information about the meeting here
October 26-27, 2017 - USP Pharmacopeia, Rockville, Maryland
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.
November 13-14, 2019 - Het Pand, University of Ghent, Belgium
2nd Conference on Next Generation Sequencing
for Adventitious Virus Detection in
Human and Veterinary Biologics
An IABS-EU Meeting
Information about the meeting here
Read more: November 13-14, 2019 - Het Pand, University of Ghent, Belgium
September 28-30, 2017 - Rockville, Maryland, USA
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
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 ?