Workshop on good clinical practices in clinical trials and post-marketing surveillance
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AbstractThe WHO South-East Asia Region (SEAR) is emerging as a major producer and supplier of vaccines to the global and regional markets. India, Indonesia and to some extent Thailand, the three South-East Asia vaccine producing countries, are expected to increasingly take over the supply of traditional EPI vaccines and new combination vaccines to meet the regional and global vaccine demands. At the same time, these countries are investing in the research and development of new vaccines. Vaccine production requires a strong regulatory system to monitor safety, quality and efficacy, and clinical trials during the different phases of vaccine development are important and critical activities. Furthermore, vaccine manufacturers in industrialized countries are increasingly looking at developing countries to conduct clinical trials, to produce or finalize vaccines (filling, packaging) and to distribute vaccines worldwide. Different approaches are taken such as joint ventures and installation of facilities by such manufacturers in developing countries. Joint ventures have already been established in India, Thailand, Indonesia and in Myanmar. In this context, national regulatory authorities (NRAs) in developing countries are faced with the challenge of fully regulating vaccines to ensure their safety, quality and efficacy, including the oversight of clinical trials that may be conducted. Developing countries are expected to establish accredited scientific and technical review committees as well as research ethics committees to ensure compliance with principles of Good Clinical Practice (GCP) consistent with international ethics norms and a monitoring system for Adverse Events Following Immunization (AEFI) in the post-licensing era of vaccine. While some Member Countries in the Region have developed capacity, most either do not have such regulatory processes in place or there are not often implemented adequately. Therefore, assisting Member Countries in strengthening capacity in this area is a priority activity for IVD.
World Health Organization, Regional Office for South-East Asia. (2007). Workshop on good clinical practices in clinical trials and post-marketing surveillance. WHO Regional Office for South-East Asia. http://www.who.int/iris/handle/10665/206147
Gov't Doc #SEA-Immun-46
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