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Workshop on International Regulatory Capacity Enhancement for Influenza Vaccines (WIRCEIV): Day 1 Agenda

June 8, 2011 - Sao Paulo, Brazil
Agenda: DAY 1 | DAY 2 | DAY 3

8:30 AM - 9:15 AM

Introduction and Welcoming Remarks

  • Workshop Co-Chairs (15 min)
    • Mr. Lahouari Belgharbi, WHO
    • Dr. Endang Woro, DCVRN
    • Dr. Daniel Miller, HHS

     

  • Brazilian National Health Surveillance Agency (ANVISA) (10 min)
    Dr. Dirceu Brás Aparecido Barbano, ANVISA, Brazil

     

  • Brazilian Ministry of Health (10 min)
    Dr. Zich Moysés, Brazilian Ministry of Health

     

  • U.S. Department of Health and Human Services (10 min)
    Dr. Bruce Gellin, HHS

 

9:15 AM - 10:30 AM

Session 1
Setting the Stage

Moderator: Dr. Daniel Miller, HHS

  1. Overview of Vaccine Capacity Building Stakeholders’ Workshop Series and path forward for GAP-2 (10 min)
    Dr. Daniel Miller, HHS

     

  2. Readout from International Vaccine Technology Workshop, 17-18 September, Hyderabad, India (10 min)
    Dr. Daniel Miller, HHS

     

  3. Readout from the First WHO NRA strategic forum of regulatory agencies for vaccines, 3-5 May 2011, Bangkok, Thailand (15 min)
    Mr. Lahouari Belgharbi, WHO

     

  4. Workshop goals and desired outcomes (10 min)
    Mr. Lahouari Belgharbi, WHO

     

  5. Q&A and Discussion (30 min)

 

10:30 AM - 11:00 AM

Morning Break

 

11:00 AM - 12:15 PM

Session 2
Keynote Addresses
Challenges of Enhancing Vaccine Regulatory Capacity in Developing Countries
Stakeholders’ Perspectives

Moderator: Mr. Lahouari Belgharbi, WHO

  1. WHO Perspective (15 min)
    Mr. Lahouari Belgharbi, WHO

     

  2. Perspectives of Policymakers (15 min)
    Dr. Zich Moysés, Brazilian Ministry of Health

     

  3. Perspectives of Technical Partners (15 min)
    Dr. Elwyn Griffiths, Health Canada

     

  4. Q&A and Discussion (30 min)

 

12:15 PM - 1:30 PM

Lunch

 

1:30 PM - 2:50 PM

Session 3
The role of WHO in Influenza Vaccine Oversight

Moderator: Mr. Lahouari Belgharbi, WHO

  1. WHO guidance on what constitutes a functional national regulatory authority (NRA) and national control laboratory (NCL) (15 min)
    Mr. Lahouari Belgharbi, WHO

     

  2. WHO strategy to facilitate regulatory decision making for licensing, marketing authorization and deployment of 2009 Pandemic Influenza vaccines world-wide (15 min)
    Dr. Claudia Alfonso, WHO

     

  3. WHO prequalification process (15 min)
    Dr. Laszlo Palkonyay, WHO

     

  4. Q&A and Discussion (30 min)

 

2:50 PM - 3:20 PM

Afternoon Break

 

3:20 PM - 4:50 PM

Session 4
Interactions between NRAs and Decision/Policy Making Government Bodies in Influenza Vaccine Preparedness

Moderators: Dr. Christoph Steffen, Agence de Medecine Preventive, the SIVAC Initiative

  1. Importance of the collaboration between National Regulatory Authorities (NRAs) and National Immunization Technical Advisory Groups (NITAGs) to ensure that vaccines are delivered adequately to the population (15 min)
    Dr. Christoph Steffen, Agence de Medecine Preventive, SIVAC Initiative

     

  2. PANEL DISCUSSION: Introduction of New Vaccines in Lower Income Countries without production capacity: decision making and respective roles of the Food and Drugs Board and the Ministry of Health and the EPI Manager (30 min)
    Mrs. Delese Mimi Darko, Food and Drugs Board, Ghana
    Dr. K.O. Antwi-Agyei, Ghana Health Service
    Mr. Samuel Boateng, Ministry of Health, Ghana

     

  3. PANEL DISCUSSION: Introduction of New Vaccines in Lower Income Countries with national production capacity: decision making and respective roles of the NIHE, Ministry of Health and the Regulatory authority (30 min)
    Dr. Nguyen Minh Hang, Ministry of Health, Viet Nam
    Ms. Nguyen Hong Nhung, Drug Administration of Viet Nam
    Dr. Nguyen Van Cuong, National Institute of Hygiene and Epidemiology, Viet Nam

     

  4. Q&A and Discussion (15 min)

 

4:50 PM - 5:00 PM

Summary and Wrap Up of Day 1

 

6:30 PM - 8:30 PM

Session 5
Working Dinner - Regional Breakout Sessions

 

Topics for discussion will include:

  1. Communications between NRAs in the Region
    • What are the most effective communication channels?
    • What efforts do exist to collaborate and share information?
    • What has worked well in relationships between NRAs in the region?

     

  2. Regulatory capacity in the Region
    • What are the critical regulatory capacity needs, gaps and strengths?
    • Were there any unique challenges faced by NRAs and policy makers in responding to the 2009 H1N1 influenza pandemic?

     

  3. Establishment of coordinating and networking regional regulatory authorities
    • Are there opportunities for approaches and/or harmonization for regional regulatory decision-making?
    • What would be the pros and cons of the EMA-like model for developing countries in the region?
    • Can NRAs serve as training centers with experts to aid train other regulators in the region?
    • Are there any regional resources that can be leveraged?

Moderators:

  • African & Eastern Mediterranean Region: Ms. Esnat Mwape, Pharmaceutical Regulatory Authority, Zambia
  • South East Asia Region: Dr. Dede Kusmiaty, National Agency of Drug and Food Control, Indonesia
  • Americas Region: Mr. Mario Matos Marcelo Moreira, ANVISA, Brazil
  • Western Pacific Region: Dr. Enver Yousuf, Medsafe, New Zealand
  • European Region: Dr. Michael Pfleiderer, Paul-Ehrlich-Institut, Germany

Last revised: August 11, 2011