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

Isentropic Curves at Magnetic Phase Transitions

Experiments on cold atom systems in which a lattice potential is ramped up on a confined cloud have raised intriguing questions about how the temperature varies along isentropic curves, and how these curves intersect features in the phase diagram. In this paper, we study the isentropic curves of two models of magnetic phase transitions- the classical Blume-Capel Model (BCM) and the Fermi Hubbard Model (FHM). Both Mean Field Theory (MFT) and Monte Carlo (MC) methods are used. The isentropic curves of the BCM generally run parallel to the phase boundary in the Ising regime of low vacancy density, but intersect the phase boundary when the magnetic transition is mainly driven by a proliferation of vacancies. Adiabatic heating occurs in moving away from the phase boundary. The isentropes of the half-filled FHM have a relatively simple structure, running parallel to the temperature axis in the paramagnetic phase, and then curving upwards as the antiferromagnetic transition occurs. However, in the doped case, where two magnetic phase boundaries are crossed, the isentrope topology is considerably more complex

A PTSD symptoms trajectory mediates between exposure levels and emotional support in police responders to 9/11: A growth curve analysis

Exposure to the terrorist attack on the World Trade Center (WTC) on 9/11/2001 resulted in continuing stress experience manifested as Posttraumatic Stress Disorder (PTSD) Symptoms in a minority of the police responders. The WTC Health Registry has followed up a large number of individuals, including police officers, at three waves of data collection from 2003 to 2011. This analysis examines the relationship between initial exposure levels, long-term PTSD symptoms, and subsequent emotional support among police responders

Rare-Earth-Doped Materials with Application to Optical Signal Processing, Quantum Information Science, and Medical Imaging Technology

Unique spectroscopic properties of isolated rare earth ions in solids offer optical linewidths rivaling those of trapped single atoms and enable a variety of recent applications. We design rare-earth-doped crystals, ceramics, and fibers with persistent or transient “spectral hole” recording properties for applications including high-bandwidth optical signal processing where light and our solids replace the high-bandwidth portion of the electronics; quantum cryptography and information science including the goal of storage and recall of single photons; and medical imaging technology for the 700-900 nm therapeutic window. Ease of optically manipulating rare-earth ions in solids enables capturing complex spectral information in 105 to 108 frequency bins. Combining spatial holography and spectral hole burning provides a capability for processing high-bandwidth RF and optical signals with sub-MHz spectral resolution and bandwidths of tens to hundreds of GHz for applications including range-Doppler radar and high bandwidth RF spectral analysis. Simply stated, one can think of these crystals as holographic recording media capable of distinguishing up to 108 different colors. Ultra-narrow spectral holes also serve as a vibration-insensitive sub-kHz frequency reference for laser frequency stabilization to a part in 1013 over tens of milliseconds. The unusual properties and applications of spectral hole burning of rare earth ions in optical materials are reviewed. Experimental results on the promising Tm3+:LiNbO3 material system are presented and discussed for medical imaging applications. Finally, a new application of these materials as dynamic optical filters for laser noise suppression is discussed along with experimental demonstrations and theoretical modeling of the process

Chronic Physical Health Consequences of Being Injured During the Terrorist Attacks on World Trade Center on September 11, 2001

Few studies have focused on injuries from the World Trade Center disaster on September 11, 2001. Severe injury has health consequences, including an increased mortality risk 10 years after injury and the risk of mental health problems, such as posttraumatic stress disorder (PTSD). The World Trade Center Health Registry identified 14,087 persons with none of a selected group of preexisting chronic conditions before 2002 who were present during and soon after the World Trade Center attacks, 1,980 of whom reported sustaining 1 or more types of injury (e.g., a broken bone or burn). Survey data obtained during 2003−2004 and 2006−2007 were used to assess the odds of reporting a diagnosis of chronic conditions (heart disease, respiratory disease, diabetes, cancer) up to 5–6 years after the attacks. Number of injury types and probable PTSD were significantly associated with having any chronic conditions diagnosed in 2002–2007. Persons with multiple injuries and PTSD had a 3-fold higher risk of heart disease than did those with no injury and no PTSD, and persons with multiple injuries and with no PTSD had a 2-fold higher risk of respiratory diseases. The present study shows that injured persons with or without comorbid PTSD have a higher risk of developing chronic diseases. Clinicians should be aware of the heightened risk of chronic heart and respiratory conditions among injured persons

Symposium: THE MULTINATIONAL ENTERPRISE AS GLOBAL CORPORATE CITIZEN

The word globalization finds its way into many commentaries these days, in different ways and different connotations. Sometimes it is thought to be beneficial, and sometimes it\u27s thought to be harmful. We have here today four people highly qualified to talk about this topic. The focus on the multinational enterprise, which is one of the terms that\u27s used for a company that does business in many jurisdictions, is the focus of today\u27s discussion, and whether and how multinational enterprises function as global corporate citizens

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.

Precision measurement of electronic ion-ion interactions between neighboring Eu3+ optical centers

We report measurements of discrete excitation-induced frequency shifts on the 7F0→5D0 transition of the Eu+ center in La:Lu:EuCl3·6D2O resulting from the optical excitation of neighboring Eu3+ ions. Shifts of up to 46.081±0.005  MHz were observed. The magnitude of the interaction between neighboring ions was found to be significantly larger than expected from the electric dipole-dipole mechanism often observed in rare earth systems. We show that a large network of interacting and individually addressable centers can be created by lightly doping crystals otherwise stoichiometric in the optically active rare earth ion, and that this network could be used to implement a quantum processor with more than ten qubits

Laser Stabilization at 1536 nm Using Regenerative Spectral Hole Burning

Laser frequency stabilization giving a 500-Hz Allan deviation for a 2-ms integration time with drift reduced to 7 kHz/min over several minutes was achieved at 1536 nm in the optical communication band. A continuously regenerated spectral hole in the inhomogeneously broadened 4I15/2(1)!4I13/2(1) optical absorption of an Er31:Y2SiO5 crystal was used as the short-term frequency reference, while a variation on the locking technique allowed simultaneous use of the inhomogeneously broadened absorption line as a long-term reference. The reported frequency stability was achieved without vibration isolation. Spectral hole burning frequency stabilization provides ideal laser sources for high-resolution spectroscopy, real-time optical signal processing, and a range of applications requiring ultra-narrow-band light sources or coherent detection; the time scale for stability and the compatibility with spectral hole burning devices make this technique complementary to other frequency references for laser stabilization