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Strategies from Pfizer & Pacific Bridge
October 04, 2007
In a session about two of the most promising pharmaceutical markets (for both sales and clinical trials) the 2007 Regulatory Affairs Professionals Society conference had well-travelled speakers to a variety of countries. We happened to hear two presentations that were designed to spare the audience the pain of easy mistakes in those developing markets. One of them was Pfizer’s head of regulatory policy in Latin America, Anthony Ventura. “I want to give you an idea of who you should be talking to,” he said. International harmonization efforts to align the rules in different countries are coming along, he said, but more likely to affect the lives of his children than the immediate future. In Latin America, Ventura said, “there are no two registration dossiers alike. The requirements are becoming less and less harmonized and more demanding as we move on.” Booming Brazil Brazil is the key nation to watch, Ventura said.…more...