Perspetiva atual e futura da nova regulamentação da investigação clínica

A investigação clínica na Europa, e em particular em Portugal, tem vindo a perder competitividade, uma situação preocupante face aos benefícios que a investigação representa para os doentes, instituições, profissionais de saúde e comunidade científica. O quadro regulamentar da investigação clínica em Portugal sofreu alterações significativas em 2014 com a implementação da Lei n.º 21/2014. Adicionalmente, o Regulamento UE n.º 536/2014, publicado no mesmo ano, será implementado a partir de maio de 2016, entrando diretamente em vigor nos países membros. Esta nova regulamentação contribuiu positivamente para o desenvolvimento da investigação clínica em Portugal. No entanto é fundamental colocar em prática todas a medidas promulgadas para que haja um crescimento sustentado do número de estudos clínicos em Portugal.

Refocusing regulatory exclusivities: Regulatory data protection and marketing exclusivity as forms of pharmaceutical innovation policy

Protection of innovation in the pharmaceutical industry has traditionally been realised through protection of inventions via patents. However, in the European Union regulatory exclusivities restricting market entry of generic products confer tailored, industry specific protection for final, marketable products. This paper retraces the protection conferred by the different forms of exclusivity and assesses them in the light of recent transparency policies of the European Medicines Agency. The purpose of the paper is to argue for rethinking the role of regulatory data as a key tool of innovation policy and for refocusing the attention from patents to the existing regulatory framework. After detailed assessment of the exclusivity regime, the paper identifies key areas of improvement calling for reassessment so as to promote better functioning of the regime as an incentive for accelerated innovation. While economic and public health analysis necessarily provide final answers as to necessity of reform, this paper provides a legal perspective to the issue, appraising the current regulatory framework and identifying areas for further analysis.

Is there a case to be made for a global patent system? The example of plant biotechnology

The assessment of patterns of patentability in plant biotechnology on the basis of existing statistics shows a considerable concentration of patents to a few countries, in particular the United States, Australia, Japan, China, Mexico, Brazil, Germany, Canada, New Zealand, South Korea, India, Spain and Hungary. These patterns suggest that there is a clear relationship between the choice of patent jurisdictions and the biotechnology regulatory framework. This observation of the geographic distribution of biotechnology patents lends credence to maintaining a system of territorial rights that allow for regulatory competition, but continuing the process of substantive patent law harmonization which potentially minimize trade barriers.

Making Board Meetings More Secure and Efficient: Purging the Paper

The Division of Professional and Occupational Licensing is an administrative unit within the Department of Labor, Licensing, and Regulation that provides support to 40 professional and occupational regulatory boards. All board members need documents to review during the meeting. Some boards use a fleet of dated laptops during the meetings to give board members the meeting materials in PDF format; however many of boards still print the meeting materials and put them into binders. .In today's age, there has to be a more efficient way to conduct meetings without all of the paper. This paper explores alternatives to paper and laptops for use at these meetings. It was concluded that a tablet with a Windows Operating System would be the best way to go.

El efecto de la definición regulatoria de banda ancha sobre la difusión y la competencia del mercado de servicios de Internet fijo en Colombia

A partir de la dinámica evolutiva de la economía de las Tecnologías de la Información y las Comunicaciones y el establecimiento de estándares mínimos de velocidad en distintos contextos regulatorios a nivel mundial, en particular en Colombia, en el presente artículo se presentan diversas aproximaciones empíricas para evaluar los efectos reales que conlleva el establecimiento de definiciones de servicios de banda ancha en el mercado de Internet fijo. Con base en los datos disponibles para Colombia sobre los planes de servicios de Internet fijo ofrecidos durante el periodo 2006-2012, se estima para los segmentos residencial y corporativo el proceso de difusión logístico modificado y el modelo de interacción estratégica para identificar los impactos generados sobre la masificación del servicio a nivel municipal y sobre las decisiones estratégicas que adoptan los operadores, respectivamente. Respecto a los resultados, se encuentra, por una parte, que las dos medidas regulatorias establecidas en Colombia en 2008 y 2010 presentan efectos significativos y positivos sobre el desplazamiento y el crecimiento de los procesos de difusión a nivel municipal. Por otra parte, se observa sustituibilidad estratégica en las decisiones de oferta de velocidad de descarga por parte de los operadores corporativos mientras que, a partir del análisis de distanciamiento de la velocidad ofrecida respecto al estándar mínimo de banda ancha, se demuestra que los proveedores de servicios residenciales tienden a agrupar sus decisiones de velocidad alrededor de los niveles establecidos por regulación.

Reviewing psychologists’ qualifications for career development practice in Australia

Vocational psychology and the practice of career development are important dimensions of the psychology discipline. This paper contains an overview of the Australian career development industry in light of recent trends, particularly the formalisation of professional career development practice. Given the advent of the Professional Standards for Career Development Practitioners, an audit of postgraduate degrees in organisational, developmental and educational, and counselling psychology was conducted to determine their alliance with the competencies of the Standards. The audit revealed significant areas of consistency on generic competencies, however there was a serious lack of training specific to career development. The implications of the audit results are discussed in light of the evolution of the career development industry and the threat to psychologists’ standing in this field.

Stepping out into the real world of education : an introduction

‘Stepping out into the real world of Education’ has been written to complement ‘Transitioning to the real world of Education’ (Millwater & Beutel, 2008). Both books are aimed at strategising the transition you are experiencing, from preservice teacher to professional educator, through issues that you will face as early career teachers from any specialist teaching strand - early childhood, primary, middle or secondary. ‘Transitioning to the real world of Education’ (Millwater & Beutel, 2008) addressed the particularities and practicalities of professional standards, life-long learning, teaching for diversity, values-education, teacher/student relationships, teaching in a digital age and teacher burnout. This text aligns with these and explores other areas, in recognition that your early career phase is the pivotal point of how much you commit to being a teacher in the long term.

Property and valuation education : an analysis of UWS property students from 1994 to 2006

The valuation and property is an evolving industry and the participants within the industry are also changing. This change is due to improved technology and construction, global nature of business today, professional standards, legal and accounting issues and environmental matters. Throughout this change in the property industry, there has also been significant change in the structure and content of tertiary property courses in Australia. Over the past thirteen years each first year cohort commencing study in the property program at the University of Western Sydney have been surveyed in relation to their background, reasons for course selection and job expectations. This paper will review this annual survey and the profile of all first year students who commenced their studies in the Bachelor of Business (Property) degree [formerly Bachelor of Commerce (Property Economics) and Bachelor of Commerce (Land Economy)] for years commencing 1994 to 2006. The paper will also provide a detailed analysis of the type of student entering the property industry and their exposure to the valuation and property sectors prior to commencing their studies.

Changing face of property students : an analysis of UWS property students from 1994 to 2003

Property is an evolving industry and the participants within the industry are also changing. This change is due to improved technology and construction, global nature of business today, professional standards, legal and accounting issues and environmental matters. Throughout this change in the property industry, there has also been significant change in the structure and content of tertiary property courses in Australia. Over the past ten years each first year cohort commencing study in the property program at the University of Western Sydney have been surveyed in relation to their background, reasons for course selection and job expectations. This paper will review the annual survey and the profile of all first year students who commenced their studies in the Bachelor of Business (Property Economics) degree [formerly Bachelor of Commerce (Property Economics) and Bachelor of Commerce (Land Economy)] for years commencing 1994 to 2003.

If teams are so good.. : science teachers' conceptions of teams and teamwork

The focus of this study is the phenomenon of teams and teamwork. Currently the Professional Standards of Queensland’s teachers state that teams are critical to teachers’ work. This study uses a phenomenographic approach to investigate science teachers’ conceptions of teams and teamwork in the science departments of fifteen Queensland State secondary schools. The research identifies eight conceptions of teams and teamwork. The research findings suggest that the team represents a collective of science teachers bounded by the Science Department and their current timetabled subject. Collaboration was found in the study to be an activity that occurred between teachers in the same social space. The research recognises a new category of relationship between teachers, designated as ‘ask-and-receive’. The research identifies a lack of teamwork within the science department and the school. There appears to be no teaming with other subject departments. The research findings highlight the non-supportive team and teamwork policies, procedures and structures in the schools and identify the lack of recognition of the specialised skills of science teachers. The implications for the schools and science teachers are considerable, as the current Professional Standards of Education Queensland and the Queensland College of Teachers provide benchmarks of knowledge and practice of teams and teamwork for teachers. The research suggests that the professional standards relating to teams and teamwork cannot be achieved in the present school environment.

Who is a journalist? : journalism in the age of blogging

As part of the first-ever World Journalism Education Congress (WJEC), attracting 440 journalism and mass communication educators and professionals from 44 countries, and held in Singapore on June 26-28, 2007, panelists Alan Knight, Cherian George, and Alex Gerlis presented a lively debate on “Who Is a Journalist.” Knight argued that Journalism paradigms are in transition. Bloggers are providing competition through their often eye-witness reports. Quality blogs are influencing journalism practices. Knight argued that journalists must adapt to and embrace the Internet. Gerlis proposed that when we now ask “Who Is a Journalist”, the answer is no longer anyone who is employed as journalist. The answer is that potentially, anyone and everyone can be a journalist. George warns again uncritically invoking professional standards as the dividing line that separates journalists from non-journalists

Encryption safe harbours and data breach notification laws

Data breach notification laws require organisations to notify affected persons or regulatory authorities when an unauthorised acquisition of personal data occurs. Most laws provide a safe harbour to this obligation if acquired data has been encrypted. There are three types of safe harbour: an exemption; a rebuttable presumption and factor-based analysis. We demonstrate, using three condition-based scenarios, that the broad formulation of most encryption safe harbours is based on the flawed assumption that encryption is the silver bullet for personal information protection. We then contend that reliance upon an encryption safe harbour should be dependent upon a rigorous and competent risk-based review that is required on a case-by-case basis. Finally, we recommend the use of both an encryption safe harbour and a notification trigger as our preferred choice for a data breach notification regulatory framework.

Embracing Philosophy and Raising the Standard of Pre-service Teacher Education Programs

In this chapter, a rationale is developed for incorporating philosophy into teacher training programs as a means of both preparing quality teachers for the 21st century and meeting the expectations detailed in the professional standards established by the statutory authority that regulates the profession in Queensland, the Queensland College of Teaching is presented. Furthermore, in-service teachers from Buranda State School, a Brisbane primary school that has been successfully teaching philosophy to its students for over 10 years, shares their experiences of teaching philosophy and how it has enhanced student learning and the quality of teaching and professionalism of the teachers. Finally, the implications of embedding philosophy into teacher training programs are explored in terms of developing the personal integrity of beginning teachers.

Embracing diversity : empowering preservice teachers for teaching gifted and talented students

This study investigated preservice teachers’ perceptions for teaching and sustaining gifted and talented students while developing, modifying and implementing activities to cater for the diverse learner. Participants were surveyed at the end of a gifted and talented education program on their perceptions to differentiate the curriculum for meeting the needs of the student (n=22). SPSS data analysis with the five-part Likert scale indicated these preservice teachers agreed or strongly agreed they had developed skills in curriculum planning (91%) with well-designed activities (96%), and lesson preparation skills (96%). They also claimed they were enthusiastic for teaching (91%) and understanding of school practices and policies (96%). However, 46% agreed they had knowledge of syllabus documents with 50% claiming an ability to provide written feedback on student’s learning. Furthermore, nearly two-thirds suggested they had educational language from the syllabus and effective student management strategies. Preservice teachers require more direction on how to cater for diversity and begin creating sustainable societies by building knowledge from direct GAT experiences. Designing diagnostic surveys associated with university coursework can be used to determine further development for specific preservice teacher development in GAT education. Preservice teachers need to create opportunities for students to realise their potential by involving cognitive challenges through a differentiated curriculum. Differentiation requires modification of four primary areas of curriculum development (Maker, 1975) content (what we teach), process (how we teach), product (what we expect the students to do or show) and learning environment (where we teach/our class culture). Ashman and Elkins (2009) and Glasson (2008) emphasise the need for preservice teachers, teachers and other professionals to be able to identify what gifted and talented (GAT) students know and how they learn in relation to effective teaching. Glasson (2008) recommends that educators keep up to date with practices in pedagogy, support, monitoring and profiling of GAT students to create an environment conducive to achieving. Oral feedback is one method to communicate to learners about their progress but has advantages and disadvantages for some students. Oral feedback provides immediate information to the student on progress and performance (Ashman & Elkins, 2009). However, preservice teachers must have clear understandings of key concepts to assist the GAT student. Implementing teaching strategies to engage innovate and extend students is valuable to the preservice teacher in focusing on GAT student learning in the classroom (Killen, 2007). Practical teaching strategies (Harris & Hemming, 2008; Tomlinson et al., 1994) facilitate diverse ways for assisting GAT students to achieve learning outcomes. Such strategies include activities to enhance creativity, co-operative learning and problem-solving activities (Chessman, 2005; NSW Department of Education and Training, 2004; Taylor & Milton, 2006) for GAT students to develop a sense of identity, belonging and self esteem towards becoming an autonomous learner. Preservice teachers need to understand that GAT students learn in a different way and therefore should be assessed differently. Assessment can be through diverse options to demonstrate the student’s competence, demonstrate their understanding of the material in a way that highlights their natural abilities (Glasson, 2008; Mack, 2008). Preservice teachers often are unprepared to assess students understanding but this may be overcome with teacher education training promoting effective communication and collaboration in the classroom, including the provision of a variety of assessment strategies to improve teaching and learning (Callahan et al., 2003; Tomlinson et al., 1994). It is also critical that preservice teachers have enthusiasm for teaching to demonstrate inclusion, involvement and the excitement to communicate to GAT students in the learning process (Baum, 2002). Evaluating and reflecting on teaching practices must be part of a preservice teacher’s repertoire for GAT education. Evaluating teaching practices can assist to further enhance student learning (Mayer, 2008). Evaluation gauges the success or otherwise of specific activities and teaching in general (Mayer, 2008), and ensures that preservice teachers and teachers are well prepared and maintain their commitment to their students and the community. Long and Harris (1999) advocate that reflective practices assist teachers in creating improvements in educational practices. Reflective practices help preservice teachers and teachers to improve their ability to pursue improved learning outcomes and professional growth (Long & Harris, 1999). Context This study is set at a small regional campus of a large university in Queensland. As a way to address departmental policies and the need to prepare preservice teachers for engaging a diverse range of learners (see Queensland College of Teachers, Professional Standards for Teachers, 2006), preservice teachers at this campus completed four elective units within their Bachelor of Education (primary) degree. The electives include: 1. Middle years students and schools 2. Teaching strategies for engaging learners 3. Teaching students with learning difficulties, and 4. Middle-years curriculum, pedagogy and assessment. In the university-based component of this unit, preservice teachers engaged in learning about middle years students and schools, and gained knowledge of government policies pertaining to GAT students. Further explored within in this unit was the importance of: collaboration between teachers, parents/carers and school personnel in supporting middle years GAT students; incorporating challenging learning experiences that promoted higher order thinking and problem solving skills; real world learning experiences for students and; the alignment and design of curriculum, pedagogy and assessment that is relevant to the students development, interests and needs. The participants were third-year Bachelor of Education (primary) preservice teachers who were completing an elective unit as part of the middle years of schooling learning with a focus on GAT students. They were assigned one student from a local school. In the six subsequent ninety minute weekly lessons, the preservice teachers were responsible for designing learning activities that would engage and extend the GAT students. Furthermore, preservice teachers made decisions about suitable pedagogical approaches and designed the assessment task to align with the curriculum and the developmental needs of their middle years GAT student. This research aims to describe preservice teachers’ perceptions of their education for teaching gifted and talented students.

Charity law reforms : overview of progress since 2001

In the UK, Singapore, Canada, New Zealand and Australia, as in many other jurisdictions, charity law is rooted in the common law and anchored on the Statute of Charitable Uses 1601. The Pemsel classification of charitable purposes was uniformly accepted, and together with a shared and growing pool of judicial precedents, aided by the ‘spirit and intendment’ rule, has subsequently allowed the law to develop along much the same lines. In recent years, all the above jurisdictions have embarked on law reform processes designed to strengthen regulatory processes and to statutorily define and encode common law concepts. The reform outcomes are now to be found in a batch of national charity statutes which reflect interesting differences in the extent to which their respective governments have been prepared to balance the modernising of charitable purposes and other common law concepts alongside the customary concern to tighten the regulatory framework.