Education Sessions

E-IN2
Pandemic Flu Preparedness

5 November 13.15-17.00 Track: Innovation

ISPE CEUs: 0.3

Gain an understanding for the US Government’s regulatory requirements for existing and new facilities related to vaccines in general, and to the Pandemic Influenza Plan in specific

The US Department of Human Health and Services (HHS) Pandemic Influenza Plan has received $5.6 billion in FY06 appropriations for pandemic preparedness and response activities. Review the status of HHS Pandemic Vaccine (H5N1) programs in the areas of advanced development, stockpiling, and infrastructure building.

Discussions include H5N1 vaccine stockpiling (egg based), H5N1 vaccine development (cell based, antigensparing, next generation recombinant) and expansion of domestic influenza vaccine manufacturing surge capacity.

Take Back to Your Job

  • Understand the Pandemic Influenza Vaccine manufacturing challenge
  • Know programs developed to meet the challenge and the successes achieved to date
  • Know current guidance from the various US Government Agencies concerning the regulation of Pandemic Influenza Vaccine manufacturing and Department of Human Health and Services Programs/ Contracts for manufacturing novel Pandemic Influenza Vaccines

Who Should Attend

All persons interested in the Department of Human Health and Services Pandemic Influenza Preparedness programs/contracts and their impact on the vaccine manufacturing community.

Agenda Topics

  • The pandemic influenza threat and pandemic influenza vaccine manufacturing challenge
  • Programs/contracts developed to meet the pandemic influenza vaccine manufacturing challenge and the success achieved to date
  • New Department of Human Health and Services programs/contracts for manufacturing novel pandemic influenza vaccines
  • The current guidance from the various US Government Agencies concerning the regulation of pandemic influenza vaccine manufacturing
  • Question and answer with panel

Session Leaders

  • Robin Robinson, Director, HHS/OS/ASPR/BARDA
  • Thomas Warf, Program Manager, HHS/BARDA

Session Speakers

  • Armen Donabedian, Sr. Program Manager, Vaccines, HHS/OS/ASPR/BARDA
  • Robert Huebner, Senior Program Manager, HHS/OS/ASPR/BARDA
  • George Robertson, Principal, Tunnell Consulting

 

Sponsors