Number Of Common Aspects Research Articles

Quality compliance in the development of cell-based medicines in non-pharma environments

Background Academic institutions and transfusion centres are positioned to lead the development of novel cell-based therapeutics up to early-stage clinical trials (and further seeking marketing authorisation) or, alternatively, its use under the hospital exemption clause [1,2]. Existing structures, including blood and tissue bank facilities, translational medical programs and skilled personnel experienced in cell culture technologies and transplantation, equips these non-commercial entities to translate research-grade cell materials into safe and commercially viable products suitable for human use. However, developers must negotiate the complex regulatory and quality requirements involving the compulsory compliance of Good Scientific Practice (GxP) regulations in the development of advanced therapy medicinal products (ATMP) [3]. Originally designed for corporate environments, implementation of GxP in non-pharmaceutical institutions may consume a considerable level of effort (particularly in terms of funding and human resources). In non-pharmaceutical environments, current quality management structures for cell therapies are highly specific for blood and bone marrow-related products, including programs administered by JACIE, NetCord, FACT, AABB, or focused upon more global quality objectives, such as ISO guidelines (particularly ISO9001). The adaptation of such either general or specific quality assurance programs into GxP may appear as a substantial effort. However, many of the requirements are common across standards and the existence of any of them in a given institution can suit up to some extent to some of the aspects covered by the GxP. Rather than focusing on each certification separately, product developers and manufacturers in all environments would benefit from a single quality management system incorporating the most convenient tools available from different standards. In the present work, we analysed the GxP requirements and those in voluntary quality accreditation schemes already present in any blood and tissue bank. A number of common aspects were found, therefore offering an opportunity to avoid duplicities in the implementation process. Our work aims at serving as a guide for the optimisation of resources available and contributes to moving towards a single quality assurance system that integrates others, thus improving efficiency.

Theory and practice at the psychoanalytic psychotherapy »site« - an attachment perspective

In sum, the psychoanalytic »site« can be defined by a number of common aspects. A therapeutic relationship, the task of meaning-making in which the client begins to make sense of problematic or symptomatic experiences and behaviours and the therapeutic action or change, which helps to promote the client's capacity to »mentalise« his own feelings and actions and those of others, which assists the reintegration of the clients repressed, disowned or projected affects or parts of the self with resulting greater sense of vitality, efficacy and »real-ness« and enhances the emotional articulacy, including mourning and processing past losses and traumata. Features characteristic of psychoanalytic psychotherapy include the above, but in addition encompass: Acknowledging from the outset with the limitations of reality, working with extra-transferential material, theoretical eclecticism, awareness of contributions from related disciplines, embracing transparency and the need for research, both qualitative and quantitative, to guide and improve outcomes for their clients, accepting the phases of the therapist's developmental process, from early naïve enthusiasm, through the 'straight and narrow' of training and strict model-adherence, to more mature, relaxed and creative integrationism. This paper started with considering the problematic relationship between theory and practice in psychoanalysis. With its emphasis on relationship rather than putative intra-psychic mechanisms, and on what can be observed rather than inferred, attachment theory has a significant contribution to make to this new field.

A comparison of bereavement services provided in hospice and palliative care settings in Australia, the UK and the USA

Bereavement support services are recognised as an integral part of hospices and palliative care services. Exploratory surveys on the nature of such services have been conducted in recent years in several countries, including the USA, UK and Australia. The purpose of this paper is to compare the main findings of these surveys and to offer preliminary suggestions on how to improve this component of care both within and across these three countries. Through this comparison, a number of common aspects of service delivery were highlighted. Common difficulties were also found, including low numbers of paid staff, variations in specialist training, insufficient levels of funding, and the lack of the use of validated bereavement assessment tools. Bereavement support is an important aspect of hospice and palliative care service delivery. In all countries, further research and policy development is required to address the common difficulties.

Modes of Moral Thought

Abstract This paper reviews current theories of moral development and points out a number of common aspects which appear to lack full empirical support. An alternative theory of moral development, proposed by Norman Williams, is tested here and its main conclusions receive tentative support. These are that moral development is cumulative rather than linear in nature and that it takes place within four separate modes ‐‐ expedient, altruistic, intuitive and heteronomous ‐‐ in parallel. It is suggested that this classification scheme provides a valuable research tool for investigating the relationship between moral thought and variables such as age, sex, intelligence and social class, but that confirmation of its basic hypotheses is essential before further research can be undertaken.