Introduction Biologics have improved the treatment of rheumatic diseases, resulting in better outcomes. However, their high cost limits access for many patients in both North America and Latin America. Following patent expiration for biologicals, the availability of biosimilars, which typically are less expensive due to lower development costs, provides additional treatment options for patients with rheumatic diseases. The availability of biosimilars in North American and Latin American countries is evolving, with differing regulations and clinical indications. Objective The objective of the study was to present the consensus statement on biosimilars in rheumatology developed by Pan American League of Associations for Rheumatology (PANLAR). Methods Using a modified Delphi process approach, the following topics were addressed: regulation, efficacy and safety, extrapolation of indications, interchangeability, automatic substitution, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. Consensus was achieved when there was agreement among 80% or more of the panel members. Three Delphi rounds were conducted to reach consensus. Questionnaires were sent electronically to panel members and comments about each question were solicited. Results Eight recommendations were formulated regarding regulation, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. Conclusion The recommendations highlighted that, after receiving regulatory approval, pharmacovigilance is a fundamental strategy to ensure safety of all medications. Registries should be employed to monitor use of biosimilars and to identify potential adverse effects. The price of biosimilars should be significantly lower than that of reference products to enhance patient access. Biomimics are not biosimilars and, if they are to be marketed, they must first be evaluated and approved according to established regulatory pathways for novel biopharmaceuticals. Key Points • Biologics have improved the treatment of rheumatic diseases. • Their high cost limits access for many patients in both North America and Latin America. • Biosimilars typically are less expensive, providing additional treatment options for patients with rheumatic diseases. • PANLAR presents its consensus on biosimilars in rheumatology

The use of biosimilar drugs for multiple sclerosis (MS) has become widespread in Latin America, with the goal of reducing costs of treatments, promoting the sustainability of healthcare systems, and improving patient access to these therapies. There is currently a need to define and comply with requirements to guarantee the efficacy, safety, and quality of these drugs. Thus, the objective of the present study was to compile up-to-date information from each Latin American country assessed on (a) approval of biosimilar drugs by regulatory agencies; (b) use of biosimilar drugs, pharmacovigilance plans, risk management; and (c) update in the knowledge on different molecules. To do so, a group of experts from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Uruguay, and Venezuela met to discuss the current situation regarding good practices and risks associated with the use of biosimilar drugs in their respective countries. Regulation, risk management plans, and pharmacovigilance in the whole continent must guide the strategies on the commercialization and access of biosimilar drugs and copies of complex molecules. Current regulations must be implemented for the registration of biosimilar drug products and complex molecules. It is paramount to ensure that new products follow the best quality standards at all stages beyond being safe and efficient. Uncontrolled interchangeability between original biological and biosimilar should be avoided. Latin America requires the implementation and full use of strong pharmacovigilance programs. National and multinational clinical studies are required to demonstrate the similarity in safety, efficacy, and immunogenicity profiles of complex molecules, as well as biological and biosimilar products.Plain Language SummaryPlain language summary available for this article.

Research ethics committees in El Salvador possess a basic knowledge of locally relevant ethical principles, though they need more training to optimize the application of bioethical principles and models to their particular contexts. Challenges increase the value of collaborative exchanges with ethics committee members in the United States. Further research on facilitating communication between host country and sponsor country ethics committees can maximize local research ethics expertise, and thus raise the standard of protecting human participants involved in international research.

Introducción. La escritura es una herramienta que construye y modifica el conocimiento. Evaluar la tarea escritora espontánea no es tarea fácil. En este trabajo se han seleccionado y analizado una serie de indicadores de calidad para la evaluación de la escritura espontánea o productiva y se ha analizado su nivel de dificultad así como la relación que existe entre la aplicación de estrategias metacognitivas al escribir y la calidad en el escrito espontáneo.Método. Los participantes en esta investigación fueron 480 estudiantes de 5º y 6º de Educación Primaria y 1º y 2º de Educación Secundaria Obligatoria (40% mujeres y 60% hombres). Se administraron varias pruebas: una subprueba de PROESC, EVAPROMES y la escritura de una historia. Se recogieron, además, las calificaciones de la asignatura de Lengua Española del curso anterior.Resultados. La calidad de los escritos producidos de forma espontánea se relaciona con el rendimiento académico en Lengua Española, siendo la metacognición, medida mediante EVAPROMES, la variable subyacente que explica las diferencias en dificultad de los indicadores de calidad.Discusión y conclusiones. Las diferencias observadas en el análisis de los indicadores por etapas (Educación Primaria vs Educación Secundaria Obligatoria) parecen ser debidas a la metodología que los docentes emplean en las aulas así como al nivel de exigencia demandado. Por otro lado, implementar tareas de escritura espontánea que exijan la aplicación de estrategias metacognitivas (metaescritura) redundaría positivamente en el rendimiento académico de los alumnos.

RESUMENEl objetivo de este trabajo ha sido la validación del cuestionario CUTIC diseñado para medir la frecuencia y el ámbito de uso de las TIC con conexión a Internet, evaluando la utilidad que tienen y la emoción que genera su uso o no uso entre jóvenes universitarios. La muestra estuvo formada por 178 estudiantes (87.6% mujeres) que cursaban 1º grado de Trabajo Social en la Universidad Complutense de Madrid durante el año académico 2016-2017. El cuestionario inicial de 48 ítems quedó reducido a los 28 ítems que mostraban mejores propiedades psicométricas. Posteriormente se evaluó mediante técnicas factoriales la adecuación de los datos al modelo teórico concluyéndose que CUTIC-28 es una herramienta válida y fiable para conocer la frecuencia de uso de la tecnología.PALABRAS CLAVE: TIC, comportamiento digital, opinión digital, dispositivos móviles, ordenador, Internet. ABSTRACT