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

Optimized Confinement of Fermions in Two Dimensions

One of the challenging features of studying model Hamiltonians with cold atoms in optical lattices is the presence of spatial inhomogeneities induced by the confining potential, which results in the coexistence of different phases. This paper presents Quantum Monte Carlo results comparing meth- ods for confining fermions in two dimensions, including conventional diagonal confinement (DC), a recently proposed 'off-diagonal confinement' (ODC), as well as a trap which produces uniform den- sity in the lattice. At constant entropy and for currently accessible temperatures, we show that the current DC method results in the strongest magnetic signature, primarily because of its judicious use of entropy sinks at the lattice edge. For d-wave pairing, we show that a constant density trap has the more robust signal and that ODC can implement a constant density profile. This feature is important to any prospective search for superconductivity in optical lattices

Modelling Animal Systems Paper: Update of the Dutch protein evaluation system for ruminants: the DVE/OEB2010 system

In the current Dutch protein evaluation system (the DVE/OEB1991 system), two characteristics are calculated for each feed: true protein digested in the intestine (DVE) and the rumen degradable protein balance (OEB). Of these, DVE represents the protein value of a feed, while OEB is the difference between the potential microbial protein synthesis (MPS) on the basis of available rumen degradable protein and that on the basis of available rumen degradable energy. DVE can be separated into three components: (i) feed crude protein undegraded in the rumen but digested in the small intestine, (ii) microbial true protein synthesized in the rumen and digested in the small intestine, and (iii) endogenous protein lost in the digestive processes. Based on new research findings, the DVE/OEB1991 system has recently been updated to the DVE/OEB2010 system. More detail and differentiation is included concerning the representation of chemical components in feed, the rumen degradation characteristics of these components, the efficiency of MPS and the fractional passage rates. For each chemical component, the soluble, washout, potentially degradable and truly non-degradable fractions are defined with separate fractional degradation rates. Similarly, fractional passage rates for each of these fractions were identified and partly expressed as a function of fractional degradation rate. Efficiency of MPS is related to the various fractions of the chemical components and their associated fractional passage rates. Only minor changes were made with respect to the amount of DVE required for maintenance and production purposes of the animal. Differences from other current protein evaluation systems, viz. the Cornell Net Carbohydrate and Protein system and the Feed into Milk system, are discussed

Crystallographic Oxide Phase Identification of Char Deposits Obtained from Space Shuttle Columbia Window Debris

Analyzing the remains of Space Shuttle Columbia has proven technically beneficial years after the vehicle breakup. This investigation focused on charred deposits on fragments of Columbia overhead windowpanes. Results were unexpected relative to the engineering understanding of material performance in a reentry environment. The TEM analysis demonstrated that the oxides of aluminum and titanium mixed with silicon oxides to preserve a history of thermal conditions to which portions of the vehicle were exposed. The presence of Ti during the beginning of the deposition process, along with the thermodynamic phase precipitation upon cool down, indicate that temperatures well above the Ti melt point were experienced. The stratified observations implied that additional exothermic reaction, expectedly metal combustion of a Ti structure, had to be present for oxide formation. Results are significant for aerospace vehicles where thermal protection system (TPS) breaches cause substructures to be in direct path with the reentry plasma.

Separation Assurance and Scheduling Coordination in the Arrival Environment

Separation assurance (SA) automation has been proposed as either a ground-based or airborne paradigm. The arrival environment is complex because aircraft are being sequenced and spaced to the arrival fix. This paper examines the effect of the allocation of the SA and scheduling functions on the performance of the system. Two coordination configurations between an SA and an arrival management system are tested using both ground and airborne implementations. All configurations have a conflict detection and resolution (CD&R) system and either an integrated or separated scheduler. Performance metrics are presented for the ground and airborne systems based on arrival traffic headed to Dallas/ Fort Worth International airport. The total delay, time-spacing conformance, and schedule conformance are used to measure efficiency. The goal of the analysis is to use the metrics to identify performance differences between the configurations that are based on different function allocations. A surveillance range limitation of 100 nmi and a time delay for sharing updated trajectory intent of 30 seconds were implemented for the airborne system. Overall, these results indicate that the surveillance range and the sharing of trajectories and aircraft schedules are important factors in determining the efficiency of an airborne arrival management system. These parameters are not relevant to the ground-based system as modeled for this study because it has instantaneous access to all aircraft trajectories and intent. Creating a schedule external to the CD&R and the scheduling conformance system was seen to reduce total delays for the airborne system, and had a minor effect on the ground-based system. The effect of an external scheduler on other metrics was mixed

Self-managing postoperative pain with the use of a novel, interactive device: a proof of concept study

Background: Pain is commonly experienced following surgical procedures. Suboptimal management is multifactorial. Objectives. The primary objective was to assess whether patients used a device (Navimed) to self-report pain over and above a normal baseline of observations. Secondary outcome measures included comparison of pain scores and patient use of and feedback on the device. Methods: In a prospective randomized controlled trial, elective gynaecological surgery patients received standard postoperative pain care or standard care plus the Navimed, which allowed them to self-report pain and offered interactive self-help options. Results: 52 female patients, 26 in each of device and standard groups, did not differ in the frequency of nurse-documented pain scores or mean pain scores provided to nurses. The device group additionally reported pain on the device (means 18.50 versus 11.90 pain ratings per day, t(32) = 2.75, p < 0.001) that was significantly worse than reported to nurses but retrospectively rated significantly less anxiety. 80% of patients found the device useful. Discussion and Conclusion: This study demonstrates that patients used the Navimed to report pain and to help manage it. Further work is required to investigate the difference in pain scores reported and to develop more sophisticated software

Exploring the Dynamics and Impacts of Failed Teamwork on the Flight Deck: A Case Study

This study examined the dynamics and impacts of failed leadership and teamwork on the flight deck through a case study analysis of seven aircraft accidents from 2000 to 2022. Using a qualitative methodology, this research focused on accidents involving Part 121 and Part 135 operators where human factors, particularly breakdowns in Crew Resource Management (CRM), contributed to safety events leading to aircraft damage, and serious injuries and or fatal outcomes. Through a review of National Transportation Safety Board (NTSB) reports and relevant literature, the study identified common themes such as poor communication, inadequate leadership, and lack of situational awareness as contributing factors to the accidents. Case studies, including Comair Flight 5191, Colgan Air Flight 3407, and UPS Flight 1354 revealed that lapses in teamwork and CRM practices were critical factors contributing to these accidents. Recommendations for mitigating these failures are proposed, emphasizing the need for enhanced CRM training, improved leadership development, and fatigue management programs. This research aims to provide insights into improving flight safety by addressing the systemic issues related to failed leadership and teamwork in aviation

Exploring the Dynamics and Impacts of Failed Teamwork in the Flight Deck: A Case Study Analysis of Contributing Factors and Mitigation Strategies

Crew Resource Management (CRM) is a crucial concept in aviation, emphasizing the coordinated use of all available resources, including human, equipment, and information, to ensure safe and efficient flight operations. CRM aims to enhance communication, decision-making, and situational awareness among flight crew members, thus reducing errors, mitigating risks, and improving overall operational efficiency. The CRM competencies include leadership, teamwork, and decision-making. The National Transportation Safety Board has determined poor teamwork was a contributing factor of major aircraft accidents. This ongoing project aims to investigate the teamwork competency within the operational hierarchies of Part 121 and Part 135 operations by examining accidents that occurred between the years 2000 and 2022. The study will delve into the dynamics of teamwork within regulatory frameworks and previous literature to identify patterns, challenges, and potential areas for improvement. By understanding the intricacies of teamwork within these operational structures, the goal is to enhance safety standards to help mitigate risks in the aviation industry