The Role and Positioning of Clinical Trial Ethics Review under Pharmaceutical Innovation Strategy / 中国医学伦理学

Ethical review runs through the whole process of drug clinical trials, and is a critical step to ensure the rights and interests of subjects. This paper analyzed and discussed the role and positioning of ethical review in new drug clinical trials, cleared the principles of ethical review, identified the responsibilities of ethical review, and clarified the authority of ethical review approval documents. The ethical review should primarily focus on the ethics of the clinical trials, not replace other professional institutions to review the clinical trials’ legality and scientific nature. Ethical approval is only one of the necessary conditions for conducting clinical trials, not the only factor. It is recommended to strengthen the publicity and popularization of scientific and technological ethics awareness, improve the clinical trial approval mechanism, and optimize the phrasing of ethical review approval documents. It is warranted to further optimize the quality of ethical review, improve the construction of ethical review system, ultimately achieve the unity of promoting innovation and preventing risks, so as to effectively realize the benign interaction between high-quality development of scientific and technological innovation and high-level safety.

Políticas de inovação em nova chave / Innovation policies in new key

RESUMO A crise que corrói o Brasil dificulta a retomada do crescimento e a elevação do patamar de competitividade da economia. A situação se torna mais grave quando confrontada com o avanço tecnológico que toma corpo nos países avançados e em desenvolvimento e que prenunciam mudanças profundas nas economias e na organização da sociedade. É urgente que o Brasil tenha condições básicas para não se distanciar ainda mais desse novo ciclo tecnológico. Este artigo, com base na experiência internacional, defende que, paradoxalmente, nos momentos de crise é que os países e empresas mais precisam aumentar seu investimento em inovação. Mais ainda, sugere que o Estado precisa se articular com a iniciativa privada, de modo a formar uma coalização entre empresas, universidades e governo, para enfrentar os desafios tecnológicos que sacodem as economias pelo mundo afora. Essas novas tendências, ainda inacessíveis à maior parte dos países emergentes, apontam para a formação de uma nova economia, articulada em torno de três grandes pilares: digitalização, integração e automação. É urgente a definição de estratégias de longa duração para que o país recupere protagonismo internacional e se destaque por sua inteligência e capacidade de fazer CT&I de alta qualidade.

ABSTRACT The current Brazilian crisis undermines the country's economic recovery and its efforts to increase competitiveness. When confronted with technologies that are bringing about deep changes in the economy and in the organization of societies, the Brazilian situation seems to be even more disadvantageous. Brazil must urgently reduce the gap between its own technological capabilities and that of advanced countries. This article draws upon international experience and argues that, precisely in moments of crisis, countries and companies need to increase investment in innovation. Moreover, it suggests that the State must articulate with the private sector to form a coalition between enterprises, universities and government to face the technological challenges that are shaking economies around the world. These new trends, still inaccessible to most emerging countries, point to the formation of a new economy, based on three main pillars: digitization, integration and automation. Brazil must urgently define long-term strategies that push the country forward to regain international prominence and stand out for its intelligence and high quality science, technology and innovation.

Innovation Strategies of Management of the Licensed Pharmacists Associations in China / 中国药房

OBJECTIVE: To provide references for the improvement of innovation of the management of licensed pharmacists associations in China. METHODS: We analyzed the characteristics of licensed pharmacists associations, defined the connotation of "management innovation" and discussed the strategies for the management innovation of licensed pharmacists associations in China. RESULTS & CONCLUSIONS: The innovation strategies for the management of licensed pharmacists associations in China include idea innovation, system innovation, technological innovation and management mode innovation etc to maintain a sustainable development of organization.