ABSTRACT Purpose: Research about how creative economy grew considerably in last years, mainly by the increase of representation that this sector has in the global economy. It is believed that creative economy's organizations have some characteristics that differentiate them for the traditional areas where creativity is relevant in the innovation process. Thus, this paper aims to analyse the process of innovation in the creative economy organizations. Originality/gap/relevance/implications: Due to still early literature in the Brazilian context, we expect to contribute to it in the business studies field. Key methodological aspects: We conducted an exploratory qualitative research study on four micro enterprises that are part of the creative industries. The theoretical approach was about innovation in creative organizations, so as it was possible to realize an analysis of innovation in the investigated business from three categories identified in the literature: organization, technology options and customers. Summary of key results: It was found that these organizations have some characteristics that differ from traditional sectors of the economy, both in the type of innovation and in the way the innovation process is managed. However, it is questionable whether the flexibility that both aids in the flow of ideas and information would be a reality in larger companies. Key considerations/conclusions: As contributions, this article raised a reflection on creativity and innovation in this segment and also on innovation in creative microenterprises.
Introduction: In 2014, Brazil has joined the growing list of countries to ban cosmetic products from being tested on animal models. The new legislation comes into force in 2019. As a result, the interest for validated alternative testing methods for safety assessment has been increasing in academia, industry and associations. However, the lack of specific legislation on the use of biological material of human origin for toxicological tests makes the access to alternative in vitro models difficult. Furthermore, importation to Brazil is not possible on timely manner. Method: In this article, we report the implementation process of a Reconstructed Human Epidermis (SkinEthic™ RHE), an alternative model internationally accepted by OECD, through a technology transfer from EPISKIN® Lyon to Brazil. Regulatory evolution has been motivating the implementation and wide use of alternative methods to animal testing in several industry segments including cosmetic and pharmaceutical. Results: Protocol has been shown to be robust and highly reproducible. Quality control parameters (histological analysis, barrier function test and tissue viability) were performed on 24 batches assembled in Brazil. SkinEthic™ RHE model use allows the full replacement of animal test methods for skin hazards identification. It has regulatory acceptance for several toxicological endpoints, such as the Draize test for skin irritation and corrosion. It allows the reduction and refining of pre-clinical protocols through tiered strategies. Implementation of SkinEthic™ RHE protocol is just a first and important step towards a new approach of toxicological safety testing in Brazil. Conclusion: The implementation was successfully done and reported here. However, in order to follow completely the new legislation up to 2019, the availability of validated models is essential. Quality control tests done on RHE batches produced in Brazil demonstrate that the model met OECD acceptance criteria and therefore can be used for reliable prediction of irritation and corrosion classification. ; TÍTULO PT: Implementação, disponibilidade e contexto regulatório de um modelo de Epiderme Humana Reconstruída no Brasil aceito pela OECDIntrodução: Em 2014, o Brasil aderiu à crescente lista de países a banir testes de produtos cosméticos em modelos animais. A nova legislação entra em vigor em 2019. Como resultado, o interesse em métodos de testes alternativos validados para avaliação de segurança tem aumentado na academia, indústria e associações. No entanto, a falta de legislação específica sobre o uso de material biológico de origem humana para testes toxicológicos dificulta o acesso aos modelos alternativos in vitro. Além disso, a importação no Brasil não é possível em tempo hábil. Método: Neste artigo, relatamos o processo de implementação de um modelo de Epiderme Humana Reconstruída (SkinEthic™ RHE) internacionalmente aceito pela OECD, através de uma transferência tecnológica da Episkin Lion para o Brasil, bem como discutimos a evolução regulatória que tem motivado a implementação e a ampla utilização de métodos alternativos à experimentação animal em diversos segmentos além do cosmético e farmacêutico. Resultados: O protocolo de fabricação dos tecidos mostrou-se robusto e altamente reprodutível, considerando os parâmetros de controle de qualidade (análise histológica, função barreira e viabilidade tecidual) analisados em 24 lotes fabricados no Brasil. Conclusões: A implementação do modelo SkinEthic™ RHE é apenas um primeiro e importante passo em direção a uma nova abordagem para testes de segurança toxicológica no Brasil, realizada com êxito e aqui relatada. No entanto, para seguir plenamente a nova legislação até 2019, a disponibilidade de modelos validados é essencial. Os testes de controle de qualidade realizados nos lotes RHE produzidos no Brasil demonstram que o modelo atende aos critérios de aceitação da OCDE e, portanto, pode ser usado para uma previsão confiável de irritação e classificação de compostos corrosivos.
