International regulatory considerations pertaining to the development of stem cell-based veterinary medicinal products.

Stem cell-based products (SCPs) are an emerging field of veterinary medicine that focuses on the regeneration, repair, or replacement of damaged tissues or organs. However, there are some issues in applying the traditional regulatory guideline for the approval of SCPs as veterinary medicinal products. This article describes the positions of Korea, US, and EU regarding SCPs, and compares the regulatory guidelines of each country for their safety evaluation. Although there are some differences in the regulatory guidelines, similar considerations in identifying the quality of SCPs and their safety has adopted. Overall, these guidelines need to be harmonized among countries.

Intention to adopt Electronic Animal Movement Permit (e-GTA) systems in Rio Grande do Sul, Brazil / Intenção de adoção de Guia de Trânsito Animal Eletrônica (e-GTA) no Rio Grande do Sul, Brasil

Control of livestock and their movement has long been recognized as a crucial for the prevention and control of diseases. In Brazil, the control of livestock movement established in 1934. Since 1995 is regulated based on the Animal Movement Permit (GTA). Since then, the process has been improved and updated on its legal framework and strategies, including the use of emerging technological alternatives, which made possible the launching of the electronic Animal Movement Permit (e-GTA) in 2011. From a broader perspective, the e-GTA is inserted in a global context of the development of Information and Communication Technology (ICT) which since the early 1980s enabled governments worldwide to drive policies for the development of electronic government systems (e-government). After that, at a global level, there was an expansion and improvement of e-government services; however, discrepancies among countries persisted. Nonetheless, the levels of adoption of e-government by citizens have been lower than those expected by government authorities, which has attracted the attention of researchers in the area. In this context, studies of this nature that used theoretical antecedents related to the adoption of ICT have exposed peculiarities of the process of adoption of e-government, demanding research efforts directed to the structuring of specific models for this area. In Brazil, studies of this nature are still at an early stage, although government actions aimed at e-government date back to the 1990s. The objective of this article was to investigate, in an exploratory way, influence factors on the adoption intention of e-government related to animal health, having the e-GTA as the object of research. The conceptual framework was defined based upon the e-Government Adoption Model (GAM) For this objective, an online questionnaire oriented to intention to adopt e-GTA was applied to equine owners of Rio Grande do Sul not users of this system. Results indicated that respondents positively evaluated the quality of their computers and cellphones, as well as their efficacy to operate them, while quality of the internet connection was considered regular. In this context, the availability of computer and cellphone resources and computer self-efficacy did not influence the intention to adopt e-GTA. Moreover, aspects related to compatibility of e-GTA with users lifestyle have a positive association with the intention to adopt e-GTA. Also the study indicated that public information campaigns could contribute to the improvement of adoption of the e-GTA. Additionally, the authors suggested that further investigations considering other livestock sectors and variables, as well as the continuity of use after the adoption, could contribute to the expansion of the knowledge on this field.(AU)

O controle dos estoques e de movimentações de animais pecuários há muito tempo é reconhecido como um fator crucial para a prevenção e resposta para a introdução e disseminação de doenças animais ou zoonóticas. No Brasil, o controle de movimentação animal foi inicialmente estabelecido em 1934 e, desde 1995, é regulamentado com base na Guia de Trânsito Animal (GTA). Desde então, o processo foi aprimorado e atualizado em seu arcabouço legal e estratégias, inclusive no uso de alternativas tecnológicas emergentes, que possibilitaram o lançamento em 2011 da Guia de Trânsito Animal Eletrônica (e-GTA). Considerado desde uma perspectiva mais abrangente, o e-GTA está inserido em um contexto global de desenvolvimento da Tecnologia da Informação e Comunicação (TIC), que desde o início dos anos 80 permite que governos em todo o mundo conduzam políticas para o desenvolvimento de sistemas de governo eletrônico (governo eletrônico). Posteriormente, a disponibilidade do governo eletrônico tem estado em expansão de qualidade e de amplitude dos serviços oferecidos, embora este processo seja permeado por desigualdades entre os países. No entanto, os níveis de adoção do governo eletrônico pelos cidadãos têm sido inferiores aos esperados pelas autoridades governamentais, o que tem atraído a atenção dos pesquisadores da área. Nesse contexto, estudos dessa natureza, que utilizaram antecedentes teóricos relacionados à adoção das TIC expuseram idiossincrasias do processo de adoção do governo eletrônico, exigindo que esforços de pesquisa sejam direcionados à estruturação de modelos específicos para essa área. No Brasil, estudos dessa natureza ainda estão em estágio inicial, embora as ações governamentais direcionadas ao governo eletrônico datem dos anos 90. Dessa forma, o objetivo deste artigo foi investigar, de forma exploratória, fatores de influência na intenção de adoção do governo eletrônico relacionado à saúde animal, tendo o e-GTA como objeto de pesquisa. A estrutura conceitual foi definida com base no Modelo de Adoção de Governo Eletrônico (GAM). Para esse objetivo, um questionário online dirigido à intenção de adoção do e-GTA foi aplicado a proprietários de equinos do Rio Grande do Sul que não eram usuários deste sistema. Os resultados indicaram que os entrevistados avaliaram positivamente a qualidade de seus computadores e telefones celulares, bem como sua eficácia em operá-los, enquanto a qualidade da conexão de internet foi considerada regular. Nesse contexto, a disponibilidade de recursos informáticos e de celulares, bem como a capacidade de operação dos mesmos não influenciaram a intenção de adoção do e-GTA. Além disso, aspectos relacionados à compatibilidade do e-GTA com o estilo de vida do usuário têm uma associação positiva com a intenção de adoção do e-GTA. Além disso, o estudo indicou que as campanhas de informação pública poderiam contribuir para o incremento na adoção efetiva do e-GTA. Finalmente, o estudo identificou oportunidades para o desenvolvimento de investigações adicionais, considerando distintas variáveis, setores produtivos e sistemas de governo eletrônico dirigidos à saúde animal, o que poderia contribuir para a expansão do conhecimento nesta área.(AU)

Therapeutic uses of metronidazole and its side effects: an update.

OBJECTIVE: Metronidazole is an antibiotic widely used in different medical conditions such as trichomoniasis, amoebiasis, and giardiasis among others. Its use has been associated with toxicity; however, it is not well characterized. In this review, we discuss the different therapeutic uses of metronidazole and its side effects in order to aid future investigation in this field. MATERIALS AND METHODS: Relevant information, original research articles, clinical trials, and reviews were collected from PubMed to know the state of the art of the different therapeutic uses of metronidazole and the reported side effects. RESULTS: Metronidazole was used by the first time in 1959, to treat an infection caused by Trichomonas vaginalis; subsequently, new therapeutic properties were discovered. Nowadays, Metronidazole is used to treat infections caused by Bacteroides, Fusobacteria and Clostridia, rosacea, oral and dental infections, bone and joint infections, gynecologic infections, endocarditis, septicemia, and respiratory tract infections. It also can be used to treat Crohn´s disease or even like prophylaxis, before surgical procedures. Metronidazole is well tolerated with mild to moderate side effects such as nausea, abdominal pain, and diarrhea. Nevertheless, serious neurotoxicity, optic neuropathy, peripheral neuropathy, and encephalopathy have been reported in rare cases. Their genotoxic effects observed in animal models are controversial in humans. CONCLUSIONS: The therapeutic use of metronidazole had increased worldwide. Even though it is widely used, metronidazole has been associated with neurotoxicity and genotoxicity; however, its side effects are not well established. Conversely, its veterinary use is restricted in some countries because of its tumor association. Subsequently, further studies are needed to discover the secure use of metronidazole and describe new usages for this drug.

OIE twinning programme for veterinary education.

Building capacity is synonymous with sustaining development. Both are required to fuel progress and propel efforts towards heightening health and security. The urgency to build capacity has been catalysed by an increasing number of sanitary crises, threats, and disease outbreaks that have spanned countries, regions and continents. Education has often bridged the gaps in learning, but it has also divided the ways in which learning is practised. Differing cultural, religious and political beliefs, together with alternate economic priorities, have meant that countries have been advocating for education to meet their own specific needs, and not necessarily those of the international community. The varying contents of veterinary curricula around the world do not always demonstrate that the initial education of veterinary students provides them with the necessary skill sets to fulfil their responsibilities as key actors in the private and public sectors of national Veterinary Services. This has resulted in discrepancies in the competencies acquired by veterinarians and their capacities to uphold good veterinary governance and practices. To address this educational imbalance, the World Organisation for Animal Health (OIE) has drafted recommendations and guidelines to assist Veterinary Education Establishments worldwide with improving the breadth and depth of their veterinary curricula in order to strengthen their national Veterinary Services. The OIE has, furthermore, developed a twinning programme for Veterinary Education Establishments, under which learning opportunities for teaching staff and students are created and shared. Twinning has, to date, proved to be an effective and powerful mechanism through which developments in veterinary education through mutual capacity and confidence-building can be sustained.

Le renforcement des capacités est synonyme de développement durable. L'un comme l'autre sont indispensables pour alimenter le progrès et canaliser les efforts vers un niveau optimal de santé et de sécurité. Le renforcement des capacités est devenu une nécessité urgente du fait du nombre croissant de crises sanitaires, de menaces et de foyers de maladies qui se propagent dans différents pays, régions et continents. L'offre éducative permet souvent de remédier à des savoirs lacunaires mais elle peut aussi créer des fractures quant aux manières d'apprendre. Les différentes croyances culturelles, religieuses et politiques mais aussi les priorités économiques successives ont souvent induit des politiques éducatives qui visent à répondre aux besoins spécifiques d'un pays plutôt qu'à satisfaire ceux de la communauté internationale. Les variations de contenu des programmes d'enseignement de la médecine vétérinaire dans le monde ne permettent pas toujours de garantir que la formation initiale des jeunes diplômés les dote des compétences requises pour exercer pleinement leurs responsabilités en tant qu'acteurs essentiels des composantes tant privées que publiques des Services vétérinaires. Cela se traduit par un écart entre les compétences acquises par les vétérinaires et les capacités requises pour soutenir une bonne gouvernance et des bonnes pratiques vétérinaires. Afin de remédier à cette disparité des contenus d'enseignement, l'Organisation mondiale de la santé animale (OIE) a préparé des projets de recommandations et de lignes directrices visant à aider les établissements d'enseignement de la médecine vétérinaire dans le monde à dispenser une formation plus étendue et approfondie, dans le but de renforcer les Services vétérinaires nationaux. En outre, le programme de jumelages entre établissements d'enseignement de la médecine vétérinaire mis en place par l'OIE offre de nouvelles perspectives pédagogiques, tant aux enseignants qu'aux étudiants. Le jumelage s'est révélé jusqu'à présent un mécanisme efficace et performant : par le renforcement mutuel des capacités et de la confiance qu'il induit, il pérennise dans les pays participants les effets de la modernisation de l'enseignement vétérinaire.

Refuerzo de capacidades es sinónimo de desarrollo sostenible. Ambos elementos son necesarios para alimentar el progreso e impulsar una labor que permita mejorar los niveles de salud y seguridad. El creciente número de crisis o amenazas sanitarias y de brotes infecciosos que se han extendido por países, regiones y continentes ha puesto de manifiesto que urge dotarse de más sólidos medios de acción. La enseñanza ha servido a menudo para aportar al alumno conocimientos que le faltaban, pero a la vez ha consagrado diferentes maneras de aprender. El distinto bagaje cultural, religioso y político y las dispares prioridades económicas de los países han llevado a una situación en que cada país apuesta por un tipo de enseñanza adaptado a sus propias necesidades específicas, y no necesariamente a las de la comunidad internacional. Los heterogéneos programas de estudios veterinarios que se siguen en el mundo no siempre sirven para que el estudiante de veterinaria salga de la facultad provisto del conjunto de aptitudes necesarias para cumplir la función que le incumbe como pieza básica de los Servicios Veterinarios nacionales, ya sea desde el sector privado o desde el público. Ello da lugar a una gran disparidad en cuanto a las competencias que adquieren los veterinarios y a su capacidad para secundar las buenas prácticas y el buen gobierno veterinarios. Con el objetivo de resolver estas discordancias en la enseñanza, la Organización Mundial de Sanidad Animal (OIE) ha elaborado recomendaciones y directrices que ayudan a establecimientos de formación veterinaria de todo el mundo a conferir más amplitud y profundidad a sus programas de estudios y, con ello, a fortalecer los Servicios Veterinarios de su país. La OIE, además, tiene formulado un programa de hermanamiento dirigido a dichos establecimientos, que ofrecen así a profesores y alumnos la posibilidad de formarse o de hacer intercambios. Por lo observado hasta la fecha, el hermanamiento constituye un potente y eficaz mecanismo con el que respaldar el desarrollo de la formación veterinaria, gracias a la creación de lazos de confianza y al refuerzo recíproco de capacidades.

[Regulatory aspects of the development, licensing, and availability of immunological veterinary medicinal products]. / Regulatorische Aspekte der Entwicklung, Zulassung und Verfügbarkeit von immunologischen Tierarzneimitteln.

Vaccines constitute an essential tool for animal health management. In addition to applying traditional vaccine development strategies to new or changing pathogens, the use of innovative approaches in this area is increasing. Recombinant vaccines often have superior safety and efficacy profiles, due to their specific attenuation and the ability to serologically distinguish vaccinated from infected animals. The more detailed understanding of the immune system has also enabled the development of immune-based therapeutics, ranging from immunological castration to tumor therapy, and cell-based therapies for the treatment of cartilage or tendon injuries are increasingly used. In many of these cases, veterinary medicine applications provide important insights for future use in human patients. The associated regulatory challenges lie on the one hand in the integration of the innovative approaches in the existing national and EU legislative framework, and on the other hand in the development of appropriate criteria to evaluate their safety and efficacy. The promotion of innovative products has to be balanced with the safety of the target population as well as contact species and, in the case of food-producing animals, food safety. From the regulatory perspective, simplified licensing procedures represent an attractive alternative on the national level.