Good Clinical Practices (GCP) in Latin America: Prospects for Regional Harmonization: A Challenge for the Twenty-First C
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35, pp. 27-34, 2001 Printed in the USA. All rights reserved. Drug Information Journal. Vol.
GOOD CLINICAL PRACTICES (GCP) IN LATIN AMERICA: PROSPECTS FOR REGIONAL HARMONIZATION: A CHALLENGE FOR THE TWENTY-FIRST CENTURY NANCIBERGAMO, RPH Latin America Coordinator, Aventis Pharmaceuticals, Inc., Bridgewater, New Jersey
VIVIANDE TRESPALACIOS, PHARMD Director, Regulatory Affairs, Pfizer Pharmaceuticals, New York, New York
MARIAL. MARQUEZ,MD Regulatory Manager-Latin
America, Lilly Research Laboratories, A Division of Eli Lilly and Company, Indianapolis, Indiana
SILVIAPEREZ,MD Regulatory Specialist, Latin America Region, 3M Pharmaceuticals, St. Paul, Minnesota
SYLVIASAMANIEGO, MS, MBA Director, Regulatory Science, Bristol-Myers Squibb Company, Princeton, New Jersey
ERICVANDERELST,MD Chief Medical Officer, Quintiles Transnational Corp., Research Triangle Park, North Carolina The Latin America Regulatory Technical Advisory Committee (LARTAC) and Pharmaceutical Research and Manufacturing of America (PhRMA)
This position paper reviews the situation and prospects for the implementation of Good Clinical Practices (GCP) regulations in Latin America. Opportunities and challenges for clinical drug development are evaluated with particular emphasis on the existing technical and political barriers. Lack of harmonization of GCP regulations, processes, procedures, and related issues across countries and between agencies within some countries hamper the progress of overall regionalization, resulting in underdevelopment of clinical research. Moreover, there is a general consensus that shortage of knowledgeable regulators, investigators, GCP training programs, and scarcity of experienced professionals in clinical drug development continue to impair progress and prevent the regionfrom reaching its full potential. Solutions to increase the implementation of the International Conference on Harmonization (ICH) GCP standards are suggested with emphasis on training and effecting technical cooperation between the pharmaceutical industry, aca-
Reprint address: Eric Vander Elst, Chief Medical Officer, Quintiles Transnational, P.O. Box 13979, Research Triangle Park, NC 27709-3979.
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N. Bergamo, V. de Trespalacios, M. L. Marquez, S. Perez, S. Samaniego, and E. Vander Elst demic institutions, and health authorities. Implementation and regional harmonization of ICH GCP regulations become more important as the entire Latin American region evolves as part of a globalized world and enters the twenQ-jirst century with scientific and technical ambitions of becoming an effective partner in the drug development area. This harmonization process should be supported by and undertaken under the umbrella of the Pan American Health Organization (PAHO) which has the responsibiliry to foster initiatives to enhance economic and health care activities, in particular when these initiatives are based on internationally harmonized principles and standards. Key Words: Good Cl
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