Qualified Person Learning Programme Development: An Example of the Tempus Joint Project Activity

The role of Qualified Person (QP) is a pivotal one in Quality Assurance within the pharmaceutical industry. The competences required are usually achieved through work experience and more formal forms of learning, such as postgraduate MSc and/or relevant short-term courses. Duties of QP in the pharmaceutical sector in Serbia used to be performed by expert pharmacists with the relevant industrial experience and a Postgraduate Specialization Degree in Drug Analysis and Quality Control. However, it has been recognized that the learning needs of QPs should be extended to include knowledge of drug formulation and manufacturing processes. Taking into account the pre-accession status of Serbia, harmonization with EU practice and policies has been emphasized. In particular, compliance with EU directives 2001/82/EC and 2001/83/EC, which detail the role of, and academic qualifications required by a QP will be necessary. In order to respond to this need which has been highlighted within the sector, the Faculty of Pharmacy, University of Belgrade took responsibility for establishing the relevant postgraduate course, and set this as one of the priorities of the current Tempus PQPharm Project. The aim of this work is to provide an example of an outcomes-based interactive approach to curriculum development performed through an international joint-project collaboration activity

<i>In vitro - in vivo </i>relations for the parenteral liposomal formulation of Amphotericin B:A clinically relevant approach with PBPK modeling

In vitro release testing is a useful tool for the quality control of controlled release parenteral formulations, but in vitro release test conditions that reflect or are able to predict the in vivo performance are advantageous. Therefore, it is important to investigate the factors that could affect drug release from formulations and relate them to in vivo performance. In this study the effect of media composition including albumin presence, type of buffer and hydrodynamics on drug release were evaluated on a liposomal Amphotericin B formulation (Ambisome®). A physiologically based pharmacokinetic (PBPK) model was developed using plasma concentration profiles from healthy subjects, in order to investigate the impact of each variable from the in vitro release tests on the prediction of the in vivo performance. It was found that albumin presence was the most important factor for the release of Amphotericin B from Ambisome®; both hydrodynamics setups, coupled with the PBPK model, had comparable predictive ability for simulating in vivo plasma concentration profiles. The PBPK model was extrapolated to a hypothetical hypoalbuminaemic population and the Amphotericin B plasma concentration and its activity against fungal cells were simulated. Selected in vitro release tests for these controlled release parenteral formulations were able to predict the in vivo AmB exposure, and this PBPK driven approach to release test development could benefit development of such formulations.</p

Adverse obstetric and perinatal outcomes following treatment of adolescent and young adult cancer: A population-based cohort study

Objective - To investigate obstetric and perinatal outcomes among female survivors of adolescent and young adult (AYA) cancers and their offspring. Methods - Using multivariate analysis of statewide linked data, outcomes of all first completed pregnancies (n = 1894) in female survivors of AYA cancer diagnosed in Western Australia during the period 1982–2007 were compared with those among females with no cancer history. Comparison pregnancies were matched by maternal age-group, parity and year of delivery. Results - Compared with the non-cancer group, female survivors of AYA cancer had an increased risk of threatened abortion (adjusted relative risk 2.09, 95% confidence interval 1.51–2.74), gestational diabetes (2.65, 2.08–3.57), pre-eclampsia (1.32, 1.04–1.87), post-partum hemorrhage (2.83, 1.92–4.67), cesarean delivery (2.62, 2.22–3.04), and maternal postpartum hospitalization>5 days (3.01, 1.72–5.58), but no excess risk of threatened preterm delivery, antepartum hemorrhage, premature rupture of membranes, failure of labor to progress or retained placenta. Their offspring had an increased risk of premature birth (<37 weeks: 1.68, 1.21–2.08), low birth weight (<2500 g: 1.51, 1.23–2.12), fetal growth restriction (3.27, 2.45–4.56), and neonatal distress indicated by low Apgar score (<7) at 1 minute (2.83, 2.28–3.56), need for resuscitation (1.66, 1.27–2.19) or special care nursery admission (1.44, 1.13–1.78). Congenital abnormalities and perinatal deaths (intrauterine or ≤7 days of birth) were not increased among offspring of survivors. Conclusion - Female survivors of AYA cancer have moderate excess risks of adverse obstetric and perinatal outcomes arising from subsequent pregnancies that may require additional surveillance or intervention

Investigation of fMRI activation in the internal capsule

<p>Abstract</p> <p>Background</p> <p>Functional magnetic resonance imaging (fMRI) in white matter has long been considered controversial. Recently, this viewpoint has been challenged by an emerging body of evidence demonstrating white matter activation in the corpus callosum. The current study aimed to determine whether white matter activation could be detected outside of the corpus callosum, in the internal capsule. Data were acquired from a 4 T MRI using a specialized asymmetric spin echo spiral sequence. A motor task was selected to elicit activation in the posterior limb of the internal capsule.</p> <p>Results</p> <p>White matter fMRI activation was examined at the individual and group levels. Analyses revealed that activation was present in the posterior limb of the internal capsule in 80% of participants. These results provide further support for white matter fMRI activation.</p> <p>Conclusions</p> <p>The ability to visualize functionally active tracts has strong implications for the basic scientific study of connectivity and the clinical assessment of white matter disease.</p

Learning and digital inclusion: the ELAMP project

The Electronic Learning and Mobility Project (ELAMP) was a nationally funded project by the Department for Children, Schools and Families, which ran from 2004 to 2010. The main aim of ELAMP was to improve the education of Traveller children, particularly highly mobile learners. ELAMP focussed upon the use of mobile technology and distance learning to support, enhance and extend young Travellers’ educational and vocational opportunities. This article will reflect upon the learning and technological experiences and opportunities that the ELAMP project provided for Traveller children, young people and their families. In doing so it will critically consider the value of information technology in working with Traveller communities and advancing their educational opportunities. Reviewing ELAMP work will also demonstrate how the use of mobile technology can improve educational outcomes and Traveller families’ digital inclusion. Now that the project has ended, this article will question why we are not using what we learnt from ELAMP to move forward

Pay progression in routinised service sector work: navigating the internal labour market in a fast food multinational company

The United Kingdom's widespread use of low‐skill, low‐paid employment has been well documented. It has been argued internal labour markets (ILMs) benefit such workers, affording them with opportunities for progression. Relatively little is known, however, about the impact of ILMs on entry level workers undertaking routinised service sector work. Drawing on qualitative data, this article explores the prospects on offer in a market leading, fast food multinational company. Potential enabling features include on‐the‐job training, a transparent and integrated pay structure and a professed culture of progression. Occupational movements to positions above the low‐pay threshold are, however, relatively rare. We conjecture this contradiction is the result of the business context in which the firm operates. The findings suggest that in sectors where price leadership strategies dominate, escape from low pay is likely to be exceptional, even within large organisations featuring some of the classic characteristics of ‘pure’ or strong ILMs

National Survey of Sea Lice (Lepeophtheirus salmonis Krøyer and Caligus elongatus Nordmann) on Fish Farms in Ireland – 2019

Farmed stocks of Atlantic salmon in Ireland are inspected on 14 occasions throughout the year to monitor sea lice levels as part of a national programme. Sea lice are a naturally occurring parasite found on marine fish, including salmonids. They are small ecto-parasitic copepod crustaceans and there are approximately 559 species. The objectives of the National Sea Lice Monitoring Programme are: To provide an objective measurement of infestation levels on farms. To investigate the nature of infestations. To provide management information to drive the implementation of control and management strategies. To facilitate further development and refinement of this strategy. The sea lice control and management strategy has five principal components: Separation of generations. Annual fallowing of sites. Early harvest of two-sea-winter fish. Targeted treatment regimes, including synchronous treatments. Agreed husbandry practices

Spiral cracks in drying precipitates

We investigate the formation of spiral crack patterns during the desiccation of thin layers of precipitates in contact with a substrate. This symmetry-breaking fracturing mode is found to arise naturally not from torsion forces, but from a propagating stress front induced by the fold-up of the fragments. We model their formation mechanism using a coarse-grain model for fragmentation and successfully reproduce the spiral cracks. Fittings of experimental and simulation data show that the spirals are logarithmic, corresponding to constant deviation from a circular crack path. Theoretical aspects of the logarithmic spirals are discussed. In particular we show that this occurs generally when the crack speed is proportional to the propagating speed of stress front.Comment: 4 pages, 5 figures, RevTe