The Regulatory Review Process in South Africa: Challenges and Opportunities for a New Improved System.

BACKGROUND: The aims of this study were to assess the regulatory review process in South Africa from 2015 to 2017, identify the key milestones and timelines; evaluate the effectiveness of measures to ensure consistency, transparency, timeliness, and predictability in the review process; and to provide recommendations for enhanced regulatory practices. METHODS: A questionnaire was completed by the Medicines Control Council (MCC) to describe the organization of the authority, record key milestones and timelines in the review process and to identify good review practices (GRevPs). RESULTS: Currently, the MCC conducts a full assessment of quality, efficacy, and safety data in the review of all applications. The overall regulatory median approval time decreased by 14% in 2017 (1411 calendar days) compared with that of 2016, despite the 27% increase in the number of applications. However, the MCC has no target for overall approval time of new active substance applications and no targets for key review milestones. Guidelines, standard operating procedures, and review templates are in place, while the formal implementation of GRevPs and the application of an electronic document management system are planned for the near future. CONCLUSIONS: As the MCC transitions to the newly established South Africa Health Products Regulatory Authority, it would be crucial for the authority to recognize the opportunities for an enhanced regulatory review and should consider models such as abridged assessment, which encompass elements of risk stratification and reliance. It is hoped that resource constraints may then be alleviated and capacity developed to meet target timelines.Peer reviewedFinal Published versio

Finding Temporally Consistent Occlusion Boundaries in Videos using Geometric Context

We present an algorithm for finding temporally consistent occlusion boundaries in videos to support segmentation of dynamic scenes. We learn occlusion boundaries in a pairwise Markov random field (MRF) framework. We first estimate the probability of an spatio-temporal edge being an occlusion boundary by using appearance, flow, and geometric features. Next, we enforce occlusion boundary continuity in a MRF model by learning pairwise occlusion probabilities using a random forest. Then, we temporally smooth boundaries to remove temporal inconsistencies in occlusion boundary estimation. Our proposed framework provides an efficient approach for finding temporally consistent occlusion boundaries in video by utilizing causality, redundancy in videos, and semantic layout of the scene. We have developed a dataset with fully annotated ground-truth occlusion boundaries of over 30 videos ($5000 frames). This dataset is used to evaluate temporal occlusion boundaries and provides a much needed baseline for future studies. We perform experiments to demonstrate the role of scene layout, and temporal information for occlusion reasoning in dynamic scenes.Comment: Applications of Computer Vision (WACV), 2015 IEEE Winter Conference o

Gravity Data Interpretation Using Different New Algorithms: A Comparative Study

Gravity data interpretation is useful in exploring regions that have different geological structures, which contain minerals, ores and oil deposits. There are different numerical methods for the model parameters (depth (z), origin location (xo), shape parameter (q) and amplitude coefficient (A)) evaluation of a covered structure such as gradient method, particle swarm optimization technique and Werner deconvolution method. In this study, application of these methods is utilized to appraise the model parametric quantity of the covered structures. The application of these methods was demonstrated by different engineered data without and with various range of noise (5%, 10%) and applied for a real example from Egypt. The result values of each method were compared together and with those published and drilling information

Introductory Chapter: Mineral Exploration from the Point of View of Geophysicists

International audienc

Persepsi Wisatawan Mengenai Kawasan Konservasi Penyu Perairan Kota Pariaman Provinsi Sumatra Barat

Tourism in Pariaman City this year to year continue to increase because of local city government in the effort of development of tourism sector, Pariaman City has a sloping beach with beautiful charm, now tourist resort has been fixed by the government of Pariaman City. In Kota pariaman there is also a turtle conservation area located on the edge of the beach gig in the village apar. Therefore, this research is conducted to find out how Tourist Perception Regarding Marine Water Turtle Conservation Area of West Sumatra Province Pariaman.This study aims to find out how the marine turtle conservation area and know how Tourist Perception Regarding Marine Water Turtle Conservation Area of West Sumatra Province Pariaman. This study uses quantitative descriptive method to examine the issues raised by analyzing the gaze of tourists who come to visit the Conservation Area. The questionnaires were distributed as many as 30 people. While data collection techniques in this study using observation, interviews, questionnaires, and documentation.Turtle Conservation of Pariaman City conducts operational activities by monitoring the location of turtle nesting habitat located along the coastline including island owned by Pariaman City. Its main function is to protect the life of diversity of flora and fauna and sustainable us

Workers’ Remittances in Yemen: Macroeconomic Determinants and Impact on Economic Growth

This study aims to examine the determinants of workers’ remittances and their impact on economic growth in Yemen. Autoregressive Distributed Lag (ARDL) bounds test to co-integration and error correction model (ECM) were applied on data covering the period from 1990 to 2014. According to the model of remittances determinants, workers’ remittances in Yemen respond to the macroeconomic conditions of both the home and host countries. It is found that, in the long-run, migrant stock and income level at the host countries are positively and strongly influence remittances level, with a feeble impact of domestic inflation rates. The effect of the home country’s income seems to be positive but insignificant in explaining the behaviour of remittances level. The model of economic growth suggests that, in the long run, the impact of workers’ remittances appears to be positive and moderate with positive and stronger influences observed for financial development and official development assistance. Accordingly, it is recommended that a lesser weight should be given to remittances in the strategic planning process, taking into consideration the increasing potentials of the conditions in the neighbouring host countries to be changed. In addition, using remittances as a means of economic growth can be enhanced by encouraging migrants to direct their savings towards productive investment activities, and via formal channels

EFFECT OF ANGIOSPERMIC EPIPHYTES ON THE RELATIVE STATUS OF ERGOSTEROL AND ELECTROLYTE LEAKAGE IN FUNGAL PATHOGENS

Objective: In the present study, emphasis has been made to assay the antifungal activity of some angiospermic epiphytes like Cuscuta reflexa, Viscum orientale, Cymbidium bicolor, Bulbophyllum propinquum, Hoya ovalifolia and Dendrophthoe falcata. Methods: The antifungal activity due to epiphytes extracts was expressed in term of reduction in dry biomass of fungi based on the relationship of ergosterol content and electrolyte leakage in fungal pathogens viz., Colletotrichum dematium, Drechslera oryzae, Fusarium oxysporum and Fusarium solani treated with epiphytes extract. Results: Treated fungi showed increased in ergostesrol content and increased electrolyte leakage confirmed the pathetic situation of fungi; hence there was fungistatic effect, which was dose-dependent. Conclusion: The angiospermic epiphytes of selected species chosen for the study could be serves an alternative eco-friendly source to synthetic fungicides

Can the optimum artificial tear treatment for dry eye disease be predicted from presenting signs and symptoms?

PURPOSE: To assess dry eye treatment with four preservative-free dry eye artificial tear treatments to facilitate evidence-based prescribing. METHODS: A randomised, single masked crossover trial of Clinitas Soothe, Hyabak, Tears Again and TheraTears artificial tears was conducted on 50 symptomatic dry eye patients, aged 60.8±14.2years. At baseline and after trialling each treatment for 4 weeks, signs and symptoms were assessed using the Ocular Surface Disease Index (OSDI), non-invasive tear break-up time, fluorescein tear break-up time, tear meniscus height (TMH), Phenol Red test, lid-parallel conjunctival folds (LIPCOF), ocular surface staining, and lipid layer grading and osmolarity (baseline visit only). RESULTS: OSDI (p=0.002), LIPCOF (p=0.014) and conjunctival staining (p<0.001) significantly improved from baseline, however, the impact of each dry eye treatment on ocular symptoms and signs was similar. Clinitas Soothe and Hyabak were preferred by 34%/30% of participants, but only subjective comparison with the other drops influenced this choice. TheraTears was preferred (by 24%) by those with a lower baseline tear volume (p=0.01) and Tears Again (by 12%) by those with a thinner baseline lipid layer (p=0.04). The treatment that afforded the greatest improvement in clinical signs did not consistently match each individual's preferred treatment. CONCLUSIONS: If prescribed to a general dry eye population, the artificial tears performed similarly, improving symptoms and conjunctival signs. However, osmolarity balanced artificial tears were the preferred treatment in individuals with low baseline tear volume and lipisomal spray for individuals with a baseline lipid layer deficiency

A finite element simulation for orthogonal cutting of UD-CFRP incorporating a novel fibre - matrix interface model

AbstractThe rapid increase in industrial utilisation of carbon fibre reinforced plastic (CFRP) composites in recent years has led to growing interest in numerical modelling of material behaviour and defect formation when machining CFRP. The inhomogeneous/anisotropic nature of CFRP however presents considerable challenges in accurately modelling workpiece defects such as debonding between the matrix and fibre phase following cutting operations. Much of the published literature has involved the use of zero thickness cohesive elements to represent the fibre-matrix interface, despite the inability of such elements to model compressive stresses. This paper details a new approach for characterising the interface region in a two-dimensional explicit finite element simulation when orthogonal machining unidirectional (UD) CFRP laminates. A cohesive zone model based on a traction-separation law is applied to small thickness (0.25μm) interface elements in order to accommodate compressive failure, which is implemented via a bespoke user subroutine. Fibre fracture is based on a maximum principal stress criterion while elastic-plastic behaviour to failure is used to represent matrix damage. The influence of varying fibre orientations (45°, 90°, 135°) on predicted cutting and thrust forces were validated against published experimental data. While the former was generally within 5% of experimental data for workpieces with 90° and 135° fibre directions, predicted thrust forces were typically underestimated by ∼30-60%. The corresponding chip formation mechanisms and sub-surface damage due to the different material phases were also investigated. The proposed model was able to predict composite behaviour and defect formation that was comparable to experimental high speed camera images outlined in the literature