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Workshop on International Regulatory Capacity Enhancement for Influenza Vaccines (WIRCEIV): Day 3 Agenda

June 10, 2011 - Sao Paulo, Brazil
Agenda: DAY 1 | DAY 2 | DAY 3

8:30 AM - 11:00 AM

Session 9
Inventory of Regulatory Models

Moderator: Dr. Maria Luz Pombo, PAHO

  1. European Medicines Agency (EMA): a model for the coordination of networking National Agencies (25 min)
    Dr Marie-Hélène Pinheiro, EMA

     

  2. Capacity building models to address needs/gaps

     

    • Overview of WHO Department of Immunization, Vaccines and Biologicals & How the WHO and its regional offices support Regulatory Capacity Building in developing countries (15 min)
      Mr. Lahouari Belgharbi, WHO

       

    • Case Study: PAHO support to Regulatory activities in Latin American and Caribbean countries

       

      • Brief introduction to PAHO assessment tool (10 min)
        Dr. Maria Luz Pombo, PAHO

         

      • Roundtable Discussion (60 min)

         

        • Representative of a Regulatory Agency approved as functional by WHO/PAHO
          • Mrs. Laura Castanheira Laura Castanheira, ANVISA, Brazil
        • PANDRH Vaccines Working Group Coordinator
          • Dr. Olga Lidia Jacobo, CECMED, Cuba
        • Coordinator of the Regional Network of Quality Control of Vaccines Laboratories (RRLNCCV)
          • Dr. Ana Agaton, INHRR, Venezuela
        • Representative of a Regulatory Agency of Regional Reference in the process of being approved as functional by WHO/PAHO.
          • Dr. Marina Rossi, ANMAT, Argentina

     

  3. Q&A and Discussion (30 min)

 

10:50 AM - 11:20 AM

Morning Break

 

11:20 AM - 12:30 PM

Session 10
WHO-Supported Regulatory Capacity Building Networks in Vaccine Trials in Developing Countries

Moderator: Dr. Liliana Chocarro, LC Plus Consulting

  • Overview of WHO-supported regulatory capacity building networks (10 min)
    Dr. Liliana Chocarro, LC Plus Consulting

     

  • DCVRN (15 min)
    Dr. Endang Woro, DCVRN

     

  • AVAREF (15 min)
    Dr. Aaron Glyn Sosola, Pharmacy, Medicines & Poisons Board, Malawi

     

  • Q&A and Discussion (30 min)

 

12:20 PM - 1:20 PM

Lunch

 

1:20 PM - 2:35 PM

Session 11
Case Studies: Mentoring Partnerships Between Regulators

Moderators: Ms. Cathy Parker, Health Canada

  1. Health Canada and the Central Drugs Standard Control Organization of India (15 min)
    Ms. Cathy Parker, Health Canada

     

  2. Thai FDA/Australian TGA Formal training (15 min)
    Dr. Yupin Lawanprasert, Thai FDA

     

  3. South-South Cooperation: Mentoring model (20 min)
    Mrs. Laura Castanheira, ANVISA, Brazil and Mrs. Olga Lidia Jacobo, CECMED, Cuba

     

  4. Q&A and Discussion (25 min)

 

2:35 PM - 4:00 PM

Session 12
Outcomes from Breakout Sessions

  1. NRAs (15 min)
    Rapporteur

     

  2. Regions (30 min)
    Rapporteur

     

  3. Policy Makers (15 min)
    Rapporteur

     

  4. Q&A and Discussion (25 min)

 

4:00 PM - 4:20 PM

Afternoon Break

 

4:20 PM - 5:00 PM

Session 13
The Path Forward: The Global Action Plan to Increase Supply and Use of Influenza Vaccines of Assured Quality

  1. Summary of key policy issues and options (10 min)
    Dr. Daniel Miller, HHS/OGHA

     

  2. Summary of key strengths and gaps (10 min)
    Dr. Endang Woro, DCVRN

     

  3. Next steps (10 min)
    Mr. Lahouari Belgharbi, WHO

     

  4. Closing remarks by Brazilian National Health Surveillance Agency (ANVISA) (10 min)
    Mr. Jaime César de Moura Olivera, ANVISA

Last revised: August 16, 2011