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x c v b r g HIV Vaccine Research:

Ethical and Regulatory Issues

I N T E R

N A T I O

N A L

(2)

RobeRt HecHt

International AIDS Vaccine Initiative - IAVI

William Saad HoSSne

National Commission on Ethics in Research/NHC/ MOH

diRceu RapoSode mello National Health

Surveillance Agency -MOH

WalteR colli

National Technical Commission of Biosafety - MST

(3)

iii HiV Vaccine ReSeaRcH: etHicaland RegulatoRy iSSueS

8:00 - 8:15 am - Registration 8:15 - 9:30 am - Official Opening

9:30 - 10:30 am - Opening Panel:

HIV Vaccine Research: Ethical and Regulatory Issues

Coordinator: Ivo Brito - National STD and AIDS Program - SHS/MOH Panelists:

10:30 - 11:00 am - Discussion 11:00 - 11:30 am - Lecture:

HIV Vaccine Development: International Scenario and Brazilian Perspectives

Panelist: Alberto Duarte

HIV Vaccine Technical Advisory Committee - National STD and AIDS Program - SHS/MOH

Fabiano geRaldo pimenta

JúnioR

Health Surveillance Department - SHS/MOH

maRiângela batiSta galVão

Simão

National STD and AIDS Program - SHS/MOH

Saladin oSmanoV

World Health Organization - WHO

antonio HoRacio toRo

ocampo

Pan-American Health Organization - PAHO

RobeRt HecHt

International AIDS Vaccine Initiative - IAVI

William Saad HoSSne

National Commission on Ethics in Research/NHC/

MOH

diRceu RapoSode mello National Health

Surveillance Agency -MOH

WalteR colli

National Technical Commission of Biosafety - MST

Saladin oSmanoV

World Health Organization - WHO RobeRt HecHt

International AIDS Vaccine Initiative - IAVI

cRiStinade albuqueRque poSSaS

National STD and AIDS Program - SHS/

MOH

P r o g r a m

Day 1

(4)

11:30 - 12:00 am - Lecture: Ethics in Research with Human Subjects Panelist: William Saad Hossne

National Commission on Ethics in Research - National Health Council - MOH 12:00 -12:15 am- Discussion - Moderator: Albanita Viana de Oliveira - State University of Rio de Janeiro

12:15 - 2:00 pm- Lunch

2:00 - 3:00 pm - Panel 1: Ethical Issues in HIV Vaccine Research

Coordinators: Eduardo Barbosa- National STD and AIDS Program - SHS/MOH Roberto Chateaubriand - Aids Support and Preventive Group of Minas Gerais - GAPA/MG

Panelists:

3:00 - 3:30 pm - Discussion Panel 1

3:30 - 4:30 pm - Panel 2: Brazilian Experiences in Collaborative and Preventive Multicentric Studies: Present Situation and Ethical Issues Coordinator: Márcio de Sá - National STD and AIDS Program - SHS/MOH Panelists:

coRina bontempo

National Commission on Ethics in Research/NHC/

MOH

Volnei gaRRaFa

Brazilian Bioethics Society mônica baRboSa

Federal University of Rio de Janeiro

JoRge beloqui

Group for Life Initiative - GIV

maRiza moRgado Oswaldo Cruz Institute - FIOCRUZ/MOH

paulo FeiJó

Federal University of Rio de Janeiro

diRceu baRtolomeu gReco Federal University of Minas Gerais

aRtuR olHoVetcHi KalicHman State STD and AIDS Program- São Paulo

(5)

v HiV Vaccine ReSeaRcH: etHicaland RegulatoRy iSSueS

4:30 - 5:00 pm - Discussion Panel 2

5:00 - 5:45 pm- Panel 3: National Experiences and Challenges in the Development of New Preventive and Therapeutic Technologies

Coordinator: Reynaldo Dietze - Technical Advisory Committee for

Technological Development - National STD and AIDS Program-SHS/MOH Panelists:

5:45 - 6:15 pm - Discussion Panel 3

P r o g r a m

JoSéda RocHa caRValHeiRo

Health Innovation Project - FIOCRUZ/

MOH

célio lopeS SilVa

University of São Paulo luiS cláudio aRRaeSde alencaR Aggeu Magalhães Research Center - FIOCRUZ/MOH

(6)

8:30 - 9:00 am - Lecture: The role of ANVISA in health regulation and pro- motion of social welfare

Panelist: Dirceu Raposo de Mello - National Health Surveillance Agency - ANVISA/MOH

9:00 - 10:00 am - Panel 1: National Experience: The role of the regulatory agencies in research, technological development, production, research material importation and approval of new products

Coordinator: Esper Kallás - Federal University of São Paulo Panelists:

10:00 - 10:30 am - Discussion Panel 1

10:30 - 11:30 am - Panel 2: International Experience: The role of the regulatory agencies in research, technological development, production, research material importation and approval of new products

Coordenador: Alexandre Menezes - International AIDS Vaccine Initiative - IAVI

Panelists:

alan Fix

National Institutes of Health - NIH

ingRid callieS

French National Agency for Research on Aids and Viral Hepatites - ANRS

SéRgio niSHioKa

Developing Countries’ Vaccine Regulators Network - DCVRN noRbeRto RecH

National Health Surveillance Agency/

MOH

aKiRa Homma Biomanguinhos - FIOCRUZ/MOH

JaiRon alciR SantoSdo naScimento

National Technical Commission of Biosafety/MST

gonzalo Vecina University of São Paulo

Day 2

(7)

P r o g r a m

vii HiV Vaccine ReSeaRcH: etHicaland RegulatoRy iSSueS

11:30 - 12:00 pm - Discussion Panel 2 12:00 - 2:00 pm - Lunch

2:00 - 4:00 pm- Panel 3: HIV Vaccine Research in IBSA countries: Ethical and Regulatory Issues

Coordenator: Ana Tapajós - International Relations Division of the Ministry of Health

Panelists:

4:00 - 4:30 pm - Discussion Panel 3 4:30 - 4:45 pm - Synthesis

Ivo Brito - National STD and AIDS Program - SHS/MOH

Cristina Câmara - Consultant for the National STD and AIDS Program - SHS/

MOH

4:45 - 5:30 pm - Perspectives and Future Procedures

Coordinator: Raldo Bonifácio - Herbert de Souza Psychosocial Care Center

5:30 pm - Conclusion

alan Fix

National Institutes of Health - NIH

ingRid callieS

French National Agency for Research on Aids and Viral Hepatites - ANRS

SéRgio niSHioKa

Developing Countries’ Vaccine Regulators Network - DCVRN

cRiStinade albuqueRque poSSaS National STD and AIDS Program – SHS/

MOH - Brazil

VaSantHa mutHuSWamy

Indian Medical Research Council–

India

catHeRine SlacK

HIV/AIDS Vaccine Ethics Group – South Africa

cRiStinade albuqueRque poSSaS

National STD and AIDS Program- SHS/MOH

coRina bontempo

National Commission on Ethics in Research/

NHC - MOH

noRbeRto RecH

National Health Surveillance Agency/MOH

JaiRon alciR SantoSdo

naScimento

National Technical Commission of Biosafety/

MST noRbeRto RecH

National Health Surveillance Agency/

MOH

aKiRa Homma Biomanguinhos - FIOCRUZ/MOH

JaiRon alciR SantoSdo naScimento

National Technical Commission of Biosafety/MST

gonzalo Vecina University of São Paulo

(8)

Sponsorship:

Support:

Ministério da Saúde

Secretaria de Vigilância em Saúde Programa Nacional de DST e Aids www.aids.gov. br

Disque Saúde: 0800 61 1997

Organization:

References

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