Conducting Observational studies in Latin America: Academia, Ethical Committees & Pharmaceutic Industry

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Brianne Simmons
5 years ago
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1 Conducting Observational studies in Latin America: Academia, Ethical Committees & Pharmaceutic Industry

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. Drug Information Association 2

3 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

4 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 Government- Academia-Pharmaceutical Industry collaboration can bring to scientific knowledge. 4

5 Need for data Local Epidemiologic & pharmacoepidemiologic data support public health policies support clinical decision tailored to each country/region population 5

6 Need for data Government, Academia and Pharmaceutical Industry Design, fund and conduct Observational studies Country, Regional or Global 6

7 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? 7

8 Challenges

9 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 9

10 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

11 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 ( ) Coordinator for Estudo Longitudinal de Saúde do Adulto (ELSA-SP). Multicentric prospective study with participants Scietific Director at São Paulo Medical Association ( ) Author "Epidemiologia: uma abordagem prática, Isabela Bensenor "Medicina de Ambulatório, Isabela Bensenor et al. "Hipertensão Arterial, Robespierre Ribeiro

12 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.

GDUFA: 2 ½ years later Impact & Importance

GDUFA: 2 ½ years later Impact & Importance Georgia Hizon Manager, Regulatory Publications Fresenius Kabi USA, LLC Disclaimer The views and opinions expressed in the following PowerPoint slides are those