Impact of regulatory assessment on clinical studies in Brazil

Autor: Russo, Luis Augusto Tavares, Eliaschewitz, Freddy Goldberg, Harada, Vitor, Trefiglio, Roberta Pereira, Picciotti, Raffaella, Machado, Paula Goulart Pinheiro, Kesselring, Gustavo Luiz Ferreira

Publikováno v: Revista da Associação Médica Brasileira, Volume: 62, Issue: 5, Pages: 447-453, Published: AUG 2016

SUMMARY Introduction: Despite the recent expansion of clinical studies allocated to Brazil, the delay of local regulatory deadlines directly impacts their completion. Objective: This article examines the allocation process of clinical studies to Braz

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Impact of regulatory assessment on clinical studies in Brazil.

Autor: Russo LA; PhD - Director of Centro de Pesquisas e Análises Clínicas (CCBR), Rio de Janeiro, RJ, Brazil., Eliaschewitz FG; MD, Researcher - Director of Centro de Pesquisas Clínicas. President of the Medical Research Committee of Sociedade Brasileira de Endocrinologia e Metabolismo (SBEM), São Paulo, SP, Brazil., Harada V; MD - Pharmacist and Lecturer of the Medical Research Graduate Program at Faculdade de Ciências Médicas da Santa Casa de São Paulo. Director of Quintiles, São Paulo, SP, Brazil., Trefiglio RP; Pharmacist and MSc in Health Economics - Partner/Owner of Idealclinops - Advisory services in Medical Research and Pharmacoeconomics, São Paulo, SP, Brazil., Picciotti R; Pharmacist and MBA - Medical Integrated Hospital and Intensive Care Division at Novartis Pharmaceuticals, São Paulo, SP, Brazil., Machado PG; MD, PhD and MBA. Head of the Medical Integrated Hospital and Intensive Care Division at Novartis Pharmaceuticals, São Paulo, SP, Brazil., Kesselring GL; MD - Director of Instituto Vis Research. Member of the Board, Sociedade Brasileira de Medicina Farmacêutica. Representative of Associação Médica Brasileira, São Paulo, SP, Brazil.

Publikováno v: Revista da Associacao Medica Brasileira (1992) [Rev Assoc Med Bras (1992)] 2016 Sep-Oct; Vol. 62 (5), pp. 447-53.