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Audio Conference | ||||||||||||
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Register for this Audio Conference Along with Asia Pacific, Latin America is one of the hottest emerging biopharmaceutical and medical device product development regions, offering access to patients and an increasingly skilled clinical trial labor base. Additionally, it offers expanded sales opportunity for branded and non-branded products as regional government and health policies evolve to meet market demands. Currently more than 80% of the regional market share of pharmaceutical sales and growth rates is distributed among Argentina, Mexico and Brazil. But with proper planning and a risk-managed approach, there is also plenty of opportunity to be found in the so called non-traditional Latin America countries for clinical trial success for both in-country and ROW marketing approvals. These countries include: Costa Rica, Dominican Republic, Ecuador, Guatemala, Panama and Venezuela. In this presentation, our speakers will draw upon extensive first-hand knowledge and experience as they discuss the pros and cons of conducting clinical research in these non-traditional countries. This audio conference will address:
About our speakers: Dr. Alberto Grignolo, Corporate Vice President and General Manager, PAREXEL Consulting, is responsible for managing a consulting staff operating throughout Europe, North America, and Japan. Dr. Grignolo oversees regulatory and development strategy consulting, regulatory submissions management, and Regulatory Authority relationship management consulting in all regions. With more than 23 years of experience in regulatory affairs, Dr. Grignolo has worked with bio/pharmaceutical companies on regulatory strategy, development programs, and in preparations and meetings with the FDA and other regulatory agencies. He has handled negotiations with regulatory agencies along the full continuum of drug development and across a range of therapeutic areas. Dr. Grignolo represents ACRO on the Executive Board of the Clinical Trials Transformation Initiative (CTTI), established by FDA in collaboration with Duke University to increase the quality and efficiency of clinical studies. Diego Glancszpigel, Vice President, Latin American Operations, PAREXEL International, has 16 years of experience in Clinical Research with a focus on assisting ccompanies in developing regulatory strategies for clinical trials in Latin America, and budget planning for investigational projects in phase I, II, III and IV in therapetuic areas including Cardiology, Infectology, Women Health, CNS and Oncology. He has leadership responsibilties for PAREXL's Latin American Operations including presence in 7 Latin American Countries. Mr. Glancszpigel is currently President of the Argentinean CRO Association. Graciela Carlota Rácaro is Senior Director, Clinical Operations and Peri-Approval Clinical Excellence (PACE), Latin America at PAREXEL International. She is responsible for all clinical and regulatory activities in Latin America. Ms. Rácaro has expertise in drug development and non-clinical and clinical research. Her clinical experience includes clinical trial monitoring, site evaluation and initiation, data collection and quality control, and compliance with FDA/EMEA regulations and GCP guidelines. Her background includes serving as clinical lead and project manager for Latin America projects as well as global programs. She has expertise across a broad range of therapeutic areas. Ms. Rácaro holds BCh. and Pharm. degrees from the College of Pharmacy and Biochemistry at the University of Buenos Aires, and completed her Master in Clinical Research and Clinical Trials Monitoring at the University Maimónides College of Medicine in Buenos Aires. Ms. Rácaro has received scientific production awards for her work on drug development teams and has spoken at numerous scientific association meetings and congresses and published many scientific papers. Who Should Attend?
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