Drug Information Association, Sheraton Buenos Aires Hotel, Buenos Aires, Argentina
Nov 20 2008
OPENING LECTURE “Trends in Global Clinical Trials: The Role of the Emerging Markets” Ronald D. Fitzmartin, Immediate Past President, DIA Board of Directors PLENARY SESSIONS Pharmacogenetic/pharmacogenomic studies. FDA guidelines on pharmacogenetics and pharmacogenomics. Ethical and legal aspects for personal data protection and the informed consent in pharmacogenetic/ pharmacogenomic studies. Industry-sponsored pharmacogenetic studies. Future trends on the regulations in Latin America. Where are they going to? Regulatory authorities from Peru, Mexico, Chile, Brazil, Argentina. Regulatory framework for clinical trials in Latin America. FDA requirements for conducting clinical trials in foreign countries. Update on new FDA requirements. Inspections in Latin America - ANMAT. Receiving an FDA inspection (round table with investigators – Argentina, Chile and Brazil). Pediatric clinical trials in Latin America. International framework of guidelines and regulations. Conducting clinical trials in Latin America. Industry/CRO experience (vaccines). Challenges in running pediatric clinical trials. A PI perspective. Guidelines for running pediatric clinical trials in Latin America.
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