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Workshop on International Regulatory Capacity Enhancement for Influenza Vaccines (WIRCEIV): Day 2 Agenda

June 9, 2011 - Sao Paulo, Brazil
Agenda: DAY 1 | DAY 2 | DAY 3

8:30 AM - 10:00 AM

Session 6
The Regulatory Pathway and Unique Challenges for Influenza Vaccines

Moderators: Dr. Enver Yousuf, Medsafe, New Zealand & Dr. Jeewon Joung, FDA, Korea

  1. Assortment of vaccine technologies (e.g. killed virus, live attenuated, recombinant subunit, viral vector, VLP, egg-based, cell-based, adjuvanted) (15 min)
    Dr. Laszlo Palkonyay, WHO

     

  2. An overview of Seasonal and Pandemic Influenza Vaccine Production (including manufacturing processes) (15 min)
    Dr. Michael Pfleiderer, EMA

     

  3. An overview of clinical requirements and non-clinical considerations for influenza vaccines (15 min)
    Dr. Norman Baylor, US FDA

     

  4. Safety monitoring throughout the influenza vaccination cycle, including post-marketing surveillance (15 min)
    Dr. Robert Ball, US FDA

     

  5. Q&A and Discussion (30 min)

 

10:00 AM - 10:30 AM

Morning Break

 

10:30 AM - 12:10 PM

Session 7
Global Preparedness for Influenza Vaccines

Moderator: Othmar Engelhardt, NIBSC, UK

  1. The WHO Global Influenza Surveillance Network (GISN) (20 min)
    Dr. Varja Grabovac, WHO

     

  2. Perspectives from Essential Regulatory Laboratories (45 min)
    • Dr. Shigeyuki Itamura, National Institute of Infectious Diseases, Japan
    • Dr. Othmar Engelhardt, NIBSC, U.K.
    • Dr. William McCormick, US FDA

     

  3. Q&A and Discussion (35 min)

 

12:10 PM - 1:30 PM

Lunch

 

1:30 PM - 4:00 PM

Session 8A and 8B (Concurrent)
Breakout Sessions

 

Session 8A: Open only to participants from NRAs

Moderators: Elwyn Grifffiths, Health Canada and Mr. Mario Matos Marcelo Moreira, ANVISA, Brazil

Panel Participants:

  • Dr. Ding Lixia, SFDA, China
  • Mrs. Olga Lidia Jacobo, CECMED, Cuba
  • Dr. Jeewon Joung, FDA, Korea
  • Dr. Aaron Sosola, Pharmacy, Medicines & Poisons Board, Malawi
  • Dr. Enver Yousef, Medsafe, New Zealand
  • Dr. Tasanee Lorchaivej, Thailand Food and Drug Administration, Thailand

 

Topics for discussion:

  1. Communications between in country-NRAs and policy makers
    • What have constituted effective relationships and communication channels between NRA and policy makers in your country?
    • What efforts do exist to collaborate and share information between NRAs and policy makers?

     

  2. Challenges faced by NRAs and policy makers in responding to the H1N1 2009 influenza pandemic
    • Examples of how established decision-making practices and priorities were challenged by the 2009 pandemic vaccine license and deployment?
    • For those nations where the government is the influenza vaccine supplier, were there ways to enhance the NRA’s ability to have their own interpretation of data?

     

  3. Establishment of coordinating and networking between NRAs and policy makers at regional level:
    • Are there opportunities for approaches and/or harmonization for regional regulatory decision-and policy-making?
    • What would be the pros and cons of the EMA-like model for developing countries?
    • Can NRA and/or policy making body serve as training centers with experts to aid and train other regulators and policy makers in the region?

 

Session 8B: Open to all participants except NRA representatives

Moderators: Daniel Miller, HHS & Dr. Roman Prymula, Ministry of Health of the Czech Republic

Panel Participants:

  • Dr. Sandra Marie Deotti, Ministry of Health, Brazil
  • Mr. Samuel Boateng, Ministry of Health, Ghana
  • Dr. Masato Mugitani, Ministry of Health, Japan
  • Dr. Phan Trong Lan, Ministry of Health, Viet Nam

 

Topics for discussion will include:

  1. Communication and information sharing
    • What has worked well in relationships between NRAs and the policy makers in your countries?
    • What information do you use in your country to make policy decisions?
    • What information would it be beneficial for you to have in order to make policy decisions? Are you getting the information you need?

     

  2. Country’s experiences with WHO vaccine deployment during the 2009 H1N1 pandemic (donors and recipients)
    • For those nations where the government is the vaccine supplier, are there ways to enhance the NRA’s ability to have their own interpretation of data?
    • Examples of how established decision-making practices and priorities were challenged by the 2009 pandemic vaccine license and deployment
    • Implications of the public procurement process on vaccine capacity
    • Stewardship: the role of government in the face of market failure

     

  3. Establishment of coordinating and networking regulatory authorities and policy making authorities
    • What would be the pros and cons of the EMA-like model for developing countries?
    • The role of immunization advisory groups in promoting vaccine use
    • Public involvement in decision-making: enhancing the profile, credibility, and outreach of immunization advisory groups
    • National Preparedness Plans: explore the value of adding guidance for NRAs and vaccine campaign planning

Last revised: August 11, 2011