Conducting Observational
studies in Latin America:
• Academia,
Ethical Committees
& Pharmaceutic Industry
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Session Chairs & Speakers
Laura Luchini, MD, PhD
Clinical Study Unit Director
sanofi-aventis, Brazil
João Toniolo, MD, PhD
Professor, Geriatric Division
UNIFESP, Brazil
Soledad Suarez Ordoñez,MD
Registry Associate Latin America
Chiltern, Argentina
Paulo Lotufo, MD, PhD
Director of Hospital Universitário,
São Paulo University, Brazil
Damian Del Percio, Lawyer
President at CECIC, Argentina
Coordinator of the Regulatory Affairs Commission at FECICLA, Argentina
Learning objectives
• Recognize challenges related to observational
studies conduct in Latin America.
• Improve knowledge about Regulations and
Ethics analysis in the region.
• Acknowledge the contribution that GovernmentAcademia-Pharmaceutical Industry
collaboration can bring to scientific knowledge.
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Need for data
Local Epidemiologic
& pharmacoepidemiologic data
support public
health policies
support clinical
decision
tailored to each
country/region population
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Need for data
Government, Academia and
Pharmaceutical Industry
Design, fund and conduct
Observational studies
Country, Regional or Global
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Need for data
• Why and how are Observational studies
conducted?
• How is the regulatory/ethics revision
environment?
• What challenges are faced?
• What solutions are implemented?
• Which results have been obtained?
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Challenges
Sharing views
Organization of Observational Studies
in Latin America
• Ethics Committee
Damian Del Percio, Lawyer
• Academia
Paulo A Lotufo, DrPH, MD, MPH
• Pharmaceutical Industry
Soledad Suarez, MD, MS
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Speakers
• Prof Damian Del Percio:
– Lawyer
– Fellow at Fogarty Program for Ethics in Clinical Research
– Post graduation on Clinical and Pharmacoly Evaluation and on Health Right
– Legislator assessor at “Comisiones de Asuntos Constitucionales y
Derechos Humanos de la Legislatura de la Ciudad de Buenos Aires”
– Member of Estudio Maglio y Asociados
– President at CECIC, Argentina
– Coordinator of the Regulatory Affairs Commission at FECICLA (“Fundación
Ética y Calidad en la investigación Clínica Latinoamericana”), Argentina
– Co-Author
• Papers on bioethics and clinical investigation
Speakers
• Prof Paulo Lotufo:
– Director of Hospital Universitario, São Paulo University since 2003
– Master and PhD at Public Health Faculty of São Paulo University
– Post Doc at Harvard Medical School (1997-99)
– Coordinator for Estudo Longitudinal de Saúde do Adulto (ELSA-SP).
Multicentric prospective study with 15.000 participants
– Scietific Director at São Paulo Medical Association (1999-2005)
– Author
• "Epidemiologia: uma abordagem prática“, Isabela Bensenor
• "Medicina de Ambulatório“, Isabela Bensenor et al.
• "Hipertensão Arterial“, Robespierre Ribeiro
Speakers
• Dr Soledad Suarez Ordoñez
– Gynecologist and Obstetrician, University of Buenos Aires.
– Master´s degree candidate in Clinical Pharmacology Research.UAI,
Buenos Aires.
– Experience in LSDs & Breast Pathology registries.
– Registry Associate, Chiltern International
– Author:
• Evaluation of patients with locally advanced breast carcinoma that received neoadyuvant
chemotherapy.
• Evaluation of bilateral carcinomas with a view to the search for any clinical, morphological or
biological marker that can help predict the onset of the second tumour.
• Very low birth weight, perinatological results.