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

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

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

Design of miniaturized wireless sensor mote and actuator for building monitoring and control

In this paper, a wireless sensor network mote hardware design and implementation are introduced for building deployment application. The core of the mote design is based on the 8 bit AVR microcontroller, Atmega1281 and 2.4 GHz wireless communication chip, CC2420. The module PCB fabrication is using the stackable technology providing powerful configuration capability. Three main layers of size 25 mm2 are structured to form the mote; these are RF, sensor and power layers. The sensors were selected carefully to meet both the building monitoring and design requirements. Beside the sensing capability, actuation and interfacing to external meters/sensors are provided to perform different management control and data recording tasks. Experiments show that the developed mote works effectively in giving stable data acquisition and owns good communication and power performance

A study of the RF characteristics for wireless sensor deployment in building environment

In this paper, The radio Frequency (RF) Monitoring and Measurement of the Environmental Research Institute (ERI) located in Cork city will be monitored and analyzed in both the Zigbee (2.44 GHz) and the industrial, scientific and medical (ISM 433 MHz). The main objective of this survey is to confirm what the noise and interferences threat signals exist in these bands. It was agreed that the surveys would be carried out in 5 different rooms and areas that are candidates for the Wireless Sensors deployments. Based on the carried on study, A Zigbee standard Wireless Sensor Network (WSN) will be developed employing a number of motes for sensing number of signals like temperature, light and humidity beside the RSSI and battery voltage monitoring. Such system will be used later on to control and improve indoor building climate at reduced costs, remove the need for cabling and both installation and operational costs are significantly reduced

Developing wireless measurement system for building deployed capacitive sensors with optimized RF front end circuit

In this paper, a prototype of miniaturized, low power, bi-directional wireless sensor node for wireless sensor networks (WSN) was designed for doors and windows building monitoring. The capacitive pressure sensors have been developed particularly for such application, where packaging size and minimization of the power requirements of the sensors are the major drivers. The capacitive pressure sensors have been fabricated using a 2.4 mum thick strain compensated heavily boron doped SiGeB diaphragm is presented. In order to integrate the sensors with the wireless module, the sensor dice was wire bonded onto TO package using chip on board (COB) technology. The telemetric link and its capabilities to send information for longer range have been significantly improved using a new design and optimization process. The simulation tool employed for this work was the Designerreg tool from Ansoft Corporation

Development of miniaturized wireless sensor nodes suitable for building energy management and modelling

Buildings consume 40% of Ireland's total annual energy translating to 3.5 billion (2004). The EPBD directive (effective January 2003) places an onus on all member states to rate the energy performance of all buildings in excess of 50m2. Energy and environmental performance management systems for residential buildings do not exist and consist of an ad-hoc integration of wired building management systems and Monitoring & Targeting systems for non-residential buildings. These systems are unsophisticated and do not easily lend themselves to cost effective retrofit or integration with other enterprise management systems. It is commonly agreed that a 15-40% reduction of building energy consumption is achievable by efficiently operating buildings when compared with typical practice. Existing research has identified that the level of information available to Building Managers with existing Building Management Systems and Environmental Monitoring Systems (BMS/EMS) is insufficient to perform the required performance based building assessment. The cost of installing additional sensors and meters is extremely high, primarily due to the estimated cost of wiring and the needed labour. From this perspective wireless sensor technology provides the capability to provide reliable sensor data at the required temporal and spatial granularity associated with building energy management. In this paper, a wireless sensor network mote hardware design and implementation is presented for a building energy management application. Appropriate sensors were selected and interfaced with the developed system based on user requirements to meet both the building monitoring and metering requirements. Beside the sensing capability, actuation and interfacing to external meters/sensors are provided to perform different management control and data recording tasks associated with minimisation of energy consumption in the built environment and the development of appropriate Building information models(BIM)to enable the design and development of energy efficient spaces