Fernández Ríos Danilo, Rubinstein Clara, Vicién Carmen
Facultad de Ciencias Exactas y Naturales, Universidad Nacional de Asunción, Asunción, Paraguay.
ILSI Argentina, Buenos Aires, Argentina - Monsanto Argentina, Buenos Aires, Argentina.
Front Bioeng Biotechnol. 2018 Apr 5;6:40. doi: 10.3389/fbioe.2018.00040. eCollection 2018.
The need for functional risk assessment bodies in general, and in the biosafety field in particular, demands continued efforts and commitment from regulatory agencies, if results that are sustainable in time are to be achieved. The lack of formal processes that ensure continuity in the application of state of the art scientific criteria, the high rotation in some cases or the lack of experienced professionals, in others, is a challenge to be addressed. Capacity building initiatives with different approaches and degrees of success have been implemented in many countries over the years, supported by diverse governmental and non-governmental organizations. This document summarizes some capacity building experiences in developing countries and concludes that risk assessors taking ownership and regulatory authorities fully committed to developing and retaining highly qualified bodies are a to achieve sustainable systems. To this end, it is essential to implement "in-house" continuing education mechanisms supported by external experts and organizations, and inter-institutional cooperation. It has to be noted that these recommendations could only be realized if policy makers understand and appreciate the value of professional, independent regulatory bodies.
总体而言,尤其是在生物安全领域,对功能风险评估机构的需求要求监管机构持续做出努力并承担责任,以便取得能够长期持续的成果。缺乏确保采用最新科学标准的连续性的正式程序、某些情况下人员更替频繁或缺乏经验丰富的专业人员,这些都是有待解决的挑战。多年来,在不同政府和非政府组织的支持下,许多国家实施了不同方法和不同程度成功的能力建设举措。本文件总结了一些发展中国家的能力建设经验,并得出结论:风险评估人员自主负责以及监管当局全力致力于发展和保留高素质机构,是实现可持续系统的关键。为此,必须实施由外部专家和组织支持的“内部”继续教育机制以及机构间合作。必须指出的是,只有政策制定者理解并重视专业、独立监管机构的价值,这些建议才能得以实现。