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Universidad Autonoma de Ciudad Ju√?¬°rez, M√?¬©xico
Scientific Tracks Abstracts: J Clin Trials
The globalization of R&D into emerging regions has continue to grow more in the last decade in Latin America, driven by many factors including improved regulatory environment, commercial markets, favorable economics with lower relative costs, access to highly skilled professional and a large pool of patients in the region. But, now with a better established atmosphere and a strong healthcare infrastructure, Latin America offers a number of advantages as a location for clinical trials, and at the same time, the region presents other challenges particularly related to the industry that must be anticipated and managed appropriately, because we still confronting significant logistical battles and delays in implementing clinical trials in the region due to improper planning of the developments by the industry, that potentially could interfere with any new regional improvements and potentially interrupt results. If the clinical research industry is willing to take the moment and better understand their processes adapting new approaches to support an efficient global drug development program in the region, the results can be notable on time and manner. This session is intended to analyze key issues, opportunities (Good), challenges (Bad) and the unknown of doing clinical trials implementation in Latin America, and to review and understand a better planning when selecting the Latin American region to participate in a Global Clinical Trial.
Sergio Guerrero received his Medical Degree from the School of Medicine of the Universidad in Juarez, Mexico. He initiated his Medical research career in Bethesda, MD (USA) participating in the transplant research technology that later lead him to manage the operation according to the Food and Drug Administration of the United States. In the last 20 years, he dedicated to the organization, managing and conducting clinical trials in the US and Latin American region for the international pharmaceutical industry on new drug/medical devices development according to US FDA, ICH/GCP guidelines, EMA, and local regulations. For numerous years, he worked as Director of a Clinical Research Center in Mexico where he managed a multispecialty medical group and investigators in the conduct of clinical trials phase I-IV. Presently, he is responsible for the Operations of a CRO in Mexico.