Masterarbeit

Conduct of Clinical Trials in Latin American Countries: Background, Regulatory Framework and Implementation of relevant EU Requirements ***

Marcus Schade (2013)

Summary
Language: English
Over the last decade and a half, Latin America has become ever more important in the conduct of clinical studies with medicinal products in humans. In times of increasing global competitiveness, factors such as easy access to comprehensive treatment naïve patient populations in major conurbations, virtually only two languages spoken in the region, advanced regulatory environment, availability of well-trained investigators and clinical staff, good infrastructure, and stable economic and political situation are among the main reasons for investment in clinical studies in this region. Essential principles and technical requirements for the registration of pharmaceuticals for human use defined by the International Conference on Harmonization (ICH) have been implemented in Latin America via the Pan American Network on Drug Regulatory Harmonization. However, experience in ICH Good Clinical Practice (GCP) is said to be good in general but there are also voices raised to assert that some further training might still be necessary.    
The largest economies, Brazil, Mexico and Argentina, plus Chile, account for the majority of all clinical trials performed in the region. Regulatory frameworks and essential requirements as well as additional specificities for the successful conduct of clinical investigations in these countries are presented and compared, showing fundamental similarities. However, different national specificities and requirements always need to be taken into consideration as well. Finally, the implementation of European requirements for the conduct of clinical trials exceeding ICH GCP has been critically examined to the extent possible.
Pages: 131
Annexes: 8 (pages: 16)