Clinical Trials in Latin America: A Virtual Summit Agenda
SESSION 1: 10:00 a.m. – 10:15 a.m. | Introduction and Explanation of How a Virtual Conference Works |
SESSION 2: 10:15 a.m. – 11:00 a.m. |
The Top 5 Latin-American Countries for Clinical Trials: Understanding Regulations in Brazil, Argentina, Mexico, Peru and Chile Elizabeth Fernandes, Associate Lawyer, Bioethics, Biotechnology and Environment, BKBG Attorneys at Law The number of clinical trials in Latin American countries has increased substantially. Countries such as Brazil, Mexico, Argentina, Chile and Peru offer many advantages to the industry. For example, they offer a large number of untapped research subjects, a capable work force, well-functioning health systems and reduced costs. There is ample value in conducting clinical trials in Latin America. The first and most important step to develop successful clinical trials in Latin America is to understand and recognize countries’ individual regulations. Attendees will:
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11:00 a.m. – 11:30 a.m. |
Break |
SESSION 3: 11:30 a.m. – 12:15 P.m. |
The Tipping Point: Ethical Challenges in Conducting Clinical Trials in Countries With Fewer Healthcare Resources — An Alternative to Medical Care? Pedro Garbes-Netto, MD, MSc, Regional Director of Clinical Development, Latin America, Sanofi Pasteur Conducting clinical trials in low health resourced countries poses real challenges when determining the differences between healthcare and clinical development. Regulators are increasingly concerned about dual ethics standards when conducting trials in developing countries. One example has been the oncology setting in which the standard care in control groups for several lung cancer trials offers much better care than those offered by public health systems throughout Latin America. Although clinical trial settings are separated from healthcare in most developed countries with clinical research activities, in Latin America these settings live side by side. Attendees will:
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SESSION 4: 12:15 p.m. – 1:00 p.m. |
Using Internal and External Resources to Develop Efficient Site Selection Teams Oscar Garcia, Dir. Clinical Research, Sanofi-Aventis Choosing which sites will enroll the required number of patients on time and on budget is crucial to the success of clinical trials. Sponsors need to build teams of varied skill sets that can properly vet and select trial sites. Drawing the required talents from multiple departments is important to assure all study requirements are met. Once sites are selecte comprehensive planning strategies are necessary to assure sites are functioning according to study protocols and regulatory guidelines. Attendees will:
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1:00 p.m. – 2:00 p.m. | Lunch Break |
SESSION 5: 2:00 p.m. – 2:45 p.m. |
Preparing Clinical Trial Sites — Vetting Everything From Couriers to Labs to Translation Services Edilson Uiechi, Clinical Research Associate, Novartis Biociencias S.A. Clinical trial sites in Latin America present challenges related to the cultures, languages and previous or lack of experience with clinical research. The most important piece of appropriate site selection, laboratories and couriers is to understand key strategies that produce high-quality and trustworthy clinical research results. Attendees will:
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2:45 p.m. – 3:15 p.m. |
Break |
SESSION 6: 3:15 p.m. – 4:00 p.m. |
Working With Investigators: Approaches to Strengthen the Sponsor-Investigator Relationship Tatiana Vogel, Independent Consultant, Clinical Research Partners Ltd., Chile, Former Associate Director Clinical Research Operations for Latin America and Research Director, Chile, Merck This session will focus on how sponsors must remain sensible to the challenges investigators face to build a stronger sponsor-investigator commitment and increase performance. Attendees will:
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SESSION 7: 4:00 p.m. – 4:45 p.m. |
Successfully Working With IRBs and Regulatory Authorities to Prevent Clinical Trial Delays Michele Barabash, Associate Director, Clinical Project Manager, Pfizer Institutional Review Boards (IRBs) and regulatory authorities can be described as both exciting to work with and downright depressing. Building a productive relationship is paramount to successful Latin American clinical trials. Trial delays can take many forms, but putting in the work upfront with IRBs and regulatory bodies pays important dividends down the road. Attendees will:
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