Final Program DoH Regional Meeting SP 2023

AGENDA
FRIDAY, 24 FEBRUARY
09:00 – 9:10
Sao Paulo Medical Association (APM) Hall, Sao Paulo, Brazil
(Av. Brigadeiro Luiz Antônio, 278, Bela Vista)
24-25 February 2023
09:10 – 9:35
09:35 – 10:45
WORLD MEDICAL ASSOCIATION
DECLARATION OF
HELSINKI
2nd REGIONAL MEETING
Welcome
– Dr. Cesar E. Fernandes, President, Brazilian Medical
Association
– Dr. Carlos V. Serrano Jr., International Relations Director,
Brazilian Medical Association
An Introduction to the DoH
Dr. Jack Resneck Jr., President, American Medical
Association
Dr. Otmar Kloiber, Secretary General, World Medical
Association (WMA)
An Overview of the Ethical Principles of the
Use of Placebo
Dr. Roseli Nomura, Adjunct Coordinator of the
National Research Ethics Commission – Brazil (CONEP),
Adjunct Professor – Escola Paulista de Medicina – UNIFESP,
Associate Professor – Faculty of Medicine – University of
São Paulo, Advisor to the Scientific Director of the Brazilian
Federation of Gynecology and Obstetrics – FEBRASGO.
Participants:
Dr. Jose Humberto Fregnani, Superintendent of
Teaching and Research at the A.C. Camargo Cancer
Center; Former Member, National Research Ethics
Commission – Brazil (CONEP); Lecturer in the Graduate
Program at Hospital de Câncer of Barretos & A.C.
Camargo Cancer Center
Dr. Carla Saenz, Regional Ethics Advisor, Pan American
Health Organization
10:45 – 11:00
11:00 – 12:00
12:00 – 13:30
Break (15 min)
Discussion: The DoH & its Principles on the Use of Placebo
Dr. José Luiz G. do Amaral, President,
• Medical Association of Sao Paulo; Former President,
• World Medical Association Brazilian Medical Association.
Participants:
Dr. Kloiber
Dr. Resneck
Dr. Sergio Surugi de Siqueira, Professor &
Research Ethics Committee Member, Pontifical
Catholic University of Parana; External Member,
Research Ethics Committee of the Pan American
Health Organization
Lunch (1h 30min)
13:30 – 15:00 Discussion: Use of Placebo: Trial-design & Methodological
Best Practices
: Dr. Joao Massud Filho, Senior
• Consultant on Drug Development, Professor
• of Post-graduation Course on Pharmaceutical
• Medicine, Honorary Fellow- Faculty of Pharmaceutical
• Medicine, UK, Visiting Researcher and Professor At
• Aeronautics Technology Institute (ITA), Regulatory and
• Clinical Consultant – Beigene Brazil
Participants:
Dr. Zaida Arteta, President, Confederación Médica
Latinoamericana y del Caribe
Dr. Paulo A. Lotufo, Professor of Medicine/Center for Clinical
& Epidemiologic Research Director, University of Sao Paulo
Dr. Alfredo J. Mansur, Professor in Cardiology, University of
Sao Paulo, Director of Clinical Staff, Instituto do Coracao
(Heart Institute), Sao Paulo University Medical School;
Coordinator of the Ethics Committee, Hospital das Clinicas,
Sao Paulo University Medical School, Member & ad hoc &
CONEP
Dr. Jose C. Nicolau, Professor, University of Sao Paulo Medical
School; Director, Acute Coronary Diseases Unit, Heart Institute
Member, Steering/executive committees of & 70 multicenter
clinical trials
15:00 – 15:15 Break (15 min)
15:15 – 16:45 Discussion: Ethical Considerations for the Use of Placebo
• : Dr. Miguel R. Jorge, Member, Review
Committee of the WMA International Code of the
Medical Ethics (2022); Former President, WMA
Participants:
Dr. Dirceu Greco, Professor Emeritus, Infectious
Diseases and Bioethics, School of Medicine,
Federal University of Minas Gerais
Dr. Mariela Mautone, Professor & Coordinator of
the Bioethics Unit of the Faculty of Medicine,
University of the Republic (Udelar), Uruguay
Dr. Saenz
Dr. Dominique Sprumont, Founding Member,
Institute of Health Law of the University of
Neuchâtel; Executive Committee Member, Council
for International Organizations of Medical Sciences
(CIOMS)
16:45 – 17:00
Summary & Closing Remarks
Dr. Resneck
Dr. Serrano
19:30
NETWORKING DINNER
(Offered by AMB – Local TBD)
09:00 – 09:05
09:05 – 10:45
Opening Remarks
Dr. Resneck
A Conversation on Regional Regulatory Perspectives on the
Use of Placebo
: Dr. Resneck
Keynote Speakers & Discussion Participants:
Dr. Lais Souza Bonilha, Coordinator, CONEP
Dr. Hilary Marston, Chief Medical Officer,
United States Food and Drug Administration
10:45 – 11:00 Break (15 min)
SATURDAY, 25 FEBRUARY
11:00 – 11:40 Q&A: Aligning the DoH with the CIOMS Guidelines
on the Use of Placebo and Beyond
Dr. Dominique Sprumont
11:40 – 11:45 Summary & Closing Remarks
Dr. Resneck
11:45 – 13:45 Closed Workgroup Meeting (over lunch)
Only WMA DoH Workgroup members
11:45 – 13:45
13:45 – 14:00 Break (15 min)
Lunch
To all participants not on the Closed Workgoup Meeting
14:00 – 16:30 City Tour (Leaving from APM Hall and return to Hotel Porto Bay
and Canopy by Hilton)