Register Here for the workshop

 

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 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 ?  

More information coming soon                                                 View the Agenda   

SAVE THE DATE

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 this meeting coming soon.

International Alliance for Biological Standardization


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