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Workshop on International Regulatory Capacity Enhancement for Influenza Vaccines (WIRCEIV)

Sao Paulo, Brazil

8-10 June 2011



The World Health Organization (WHO), the U.S. Department of Health, and Human Services (HHS) and other like-minded organizations and governments are committed to assisting in the creation of regionally-based, independent and sustainable vaccine production capacity in developing and emerging economy countries through capacity building and technology transfer.  As a means of initiating a coordinated discussion among the international community regarding this shared goal, WHO and HHS convened the Sustainable Influenza Vaccine Production Capacity Stakeholders’ Workshop in Washington D.C. in January 2010.  A key theme that emerged during the workshop discussions was the fact that sustainable vaccine production capacity cannot be achieved in the absence of robust national regulatory systems.  A robust regulatory system is one the exhibits the capability to perform their regulatory functions with consistency under a wide range of conditions.  There is a need to increase the current investment by WHO in strengthening regulatory oversight in parallel with improving manufacturing facilities.

Building upon the Stakeholders’ Workshop, WHO and HHS hosted the Workshop on International Regulatory Capacity Enhancement for Influenza Vaccines (WIRCEIV).  International regulatory capacity enhancement is defined as any efforts related to the development, utilization and enforcement of international scientific regulatory standards that help assure the efficacy, safety and quality of a regulated product.  This follow-up workshop differed from the Stakeholders’ Workshop in that it focused on regulatory issues and expanded the scope beyond influenza vaccines.  The workshop brought together regulatory experts and policy makers to identify current needs and gaps in vaccine regulatory oversight in developing countries; discuss the development of a coordinated approach to address needs and gaps; generate ideas for leveraging existing resources; discuss the roles and responsibilities of stakeholders; and delineate potential policy issues and options for the short, medium, and long-term.

The WIRCEIV informed the review and refinement of the implementation plan of the WHO Global Pandemic Influenza Action Plan to Increase Vaccine Supply (GAP), as part of the formulation of a GAP-2 in 2011.  The new implementation plan will align a timeline to stakeholder roles and responsibilities in the creation of sustainable influenza vaccine production capacity worldwide.


  • Identify current needs and gaps in vaccine regulatory capacity that must be addressed in order to meet the needs of developing countries.
  • Identify drivers and obstacles to develop sustainable vaccine regulatory capacity, as well as recommendations to overcome challenges.
  • Explore comparability between regulatory challenges associated with influenza vaccine production and regulatory challenges faced by other vaccines.
  • Discuss roles and responsibilities of stakeholders including government agencies and ministries, international organizations, the private sector, and non-governmental organizations.
  • Provide an opportunity for regulators and policy makers and in low, mid and high income nations to foster partnerships.
  • Delineate policy issues and options for the short-, medium-, and long-term.


Executive Summary

Executive Summary(PDF - 136kb)


Workshop Co-Chairs

Mr. Lahouari Belgharbi
World Health Organization

Dr. Endang Woro
Developing Countries' Vaccine Regulators Network

Dr. Daniel Miller
U.S. Department of Health and Human Services



Final Agenda(PDF - 195kb)



Workshop Hosted by:

The Brazilian National Health Surveillance Agency (ANVISA)






Networking Models Contributing to Regulatory Capacity Building-Influenza Vaccines

Regulatory Bodies Contributing to International Regulatory Capacity Building 


WHO Website for presentations and additional information

Contact Information

Alexandra Ganim, MPH
International Influenza Unit, Office of Global Affairs
U.S. Department of Health and Human Services