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This presentation was given at Geronte's periodic meeting in Bordeaux at the Durkheim amphitheater on September 26th. It includes a project progress review for the consortium and a reminder of standard operating procedures and process with specific amphasis on the PEDR, EMP and DMP.&nbsp

Background: Different factors affect the success of standard operational procedures (SOPs). This study was conducted to explore the viewpoints of employees of Tehran Oil Refining Company about factors affecting the usability of SOPs. Methods: This qualitative study was a conventional content analysis research conducted on the oil refining company employers 2020, using the semi-structured interviews. The data were analyzed by content analysis method using MAXQDA software. Results: The results showed that the employees had a positive perception toward the standard operating procedures and most of them used these procedures to improve work performance and reduce accidents. Also, from the viewpoint of the employees, organizational factors (desirable organizational culture, continuous supervision and evaluation and assurance of accurate implementation of instructions, and continuous personnel training), individual factors (positive perception of the personnel about the organization goals, rules obedience of the personnel, positive experiences of personnel from the implementation of instructions in the past), and environmental factors (environmental dynamics and their related SOP dynamics, desirable but formal relationships of managers and supervisors with personnel as well as optimal and standard work schedule) had a positive effect on the applicability of these procedures. Conclusion: The findings of this study showed that the employees, consider standard operating procedures of organizational, individual, and environmental factors effective in using standard operating instructions. Therefore, to increase the applicability of these procedures, the employees should consider their opinions.

This paper develops and analyses a population density-dependent mathematical model to study the transmission dynamics of COVID-19 in crowded settlements such as refugee camps, schools, markets and churches. The model quantifies the potential impact of physical/social distancing and population density on the disease burden. It further determines the number of secondary infections that may arise from having one infectious individual in a high population-activity area. Results reveal that with no fatalities, the reproduction numbers associated with asymptomatic and symptomatic cases are inversely proportional to; the habitat area size, and the efforts employed in tracing and hospitalising these cases. The critical habitat area below which the disease dies out is directly proportion to the time taken to identify and hospitalise infected individuals. Results also show that disease persistence in the community is guaranteed even with minimal admission of infected individuals. In a high-activity area with 70,000 individuals, results indicate that if 10% of these individuals do not adhere to standard operating procedures (SOPs) when allocated an area of 1m2 per individual, then every infectious seeder will cause approximately one new infection within 12 hours of activity. On the other hand, if the area occupied by the 70,000 individuals is increased to 1km2 then even at the lowest explored level of adherence to SOPs, the arising number of new cases within 12 hours would be less than one per infectious seeder. We conclude that proper use of masks and physical distancing measures should be highly enforced in crowded settings.

Training to ensure good documentation practices and adherence to regulatory requirements in human nutrition randomized controlled trials has not been given sufficient attention. Furthermore, it is difficult to find this information conveniently organized or in a form relevant to nutrition protocols. Current gaps in training and research surveillance exist in clinical nutrition research because training modules emphasize drugs and devices, promote reliance on monitoring boards, and lack nutrition expertise on human nutrition research teams. Additionally, because eating is essential, ongoing, and highly individualized, it is difficult to distinguish risks associated with interventions from eating under free-living conditions. Controlled-feeding trials provide an option to gain more experimental control over food consumed, but at a price of less external validity, and may pose human behavior issues that are unrelated to the intervention. This paper covers many of the expected practices for documentation and regulation that may be encountered in planning and conducting nutrition intervention trials with examples and references that should be useful to clinical nutrition researchers, funders of research, and research institutions. Included are definitions and guidance on clinical nutrition research oversight (institutional review boards, data safety and monitoring boards, US FDA); participant safety; standard operating procedures; training of investigators, staff, and students; and local culture and reporting requirements relevant to diet-related clinical research conduct and documentation.

Standard operating procedures drive everyday practice within any organization, including those within a forensic setting. In the event of unusual circumstances, organizations must respond rapidly to address the impact on operations while ensuring that the quality and safety outcomes of routine services are not affected. This case study illustrates how standard operating procedures can be newly developed or modified, and rapidly deployed and quickly revised, to address unusual circumstances. The response to the COVID-19 pandemic is used as an example in this case report.

Introduction Patients with Peyronie's disease may experience significat distress. The choice of treatment depends on a variety of factors, including the stage of the disease, the presence of pain, severity and direction of the curvature, penile length and the quality of erectile function. Aim To review the evidence associated with surgical treatment of Peyronie‘s Disease and provide clinical recommendations on behalf of the European Society for Sexual Medicine. 131 peer-reviewed studies and systematic reviews, which were published from 2009 to 2019 in the English language, were included. Methods MEDLINE, Google Scholar and EMBASE were searched for randomized clinical trials, meta-analyses, open-label prospective and retrospective studies. Main Outcome Measure The panel provided statements on clinically relevant questions including patient involvement in the decision process, indications for surgery, choice of the approach, and the management of patient expectations. A comparison of the different grafts used in patients who have undergone plaque incision/excision and grafting in order to identify an ideal graft, has been carried out. The prevalence of postoperative complications has been summarized. Levels of evidence were provided according to the Oxford 2011 criteria and Oxford Centre for Evidence-Based Medicine recommendations. Results In order to allow shared decision making, a patient preoperative counselling regarding the pros and cons of each intervention is recommended. In particular, adverse effects of surgical treatments should be discussed to set realistic understanding and expectations of surgical outcomes and ultimately improve postoperative satisfaction rates. Surgical treatment should be only offered in the chronic phase of the condition, when the deformity and/or degree of erectile dysfunction, prevent patients from engaging in satisfying sexual interaction, or if the deformity is the cause of severe bother. Conclusions Current European Society for Sexual Medicine recommendations cover several aspects of Peyronie's disease treatment. These recommendations aim both to ensure patients and partners have accurate and realistic expectations of their treatment options, as well as to formulate algorithms to guide clinician management pathways. Osmonov D, Ragheb A, Ward S et al, ESSM Position Statement on Surgical Treatment of Peyronie's Disease. Sex Med 2022;10:100459.

This package contains supporting information for the meteorological data collected at Cathedral Peak's OIC AWS station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the hydrological data collected at SODWANA's BAY LODGE station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the meteorological data collected at Jonkershoek's 19B station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the micro meteorological data collected at Cathedral Peak's Spectral probe - VI station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the meteorological data collected at Jonkershoek's Dwarsberg weather station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the hydrological data collected at Cathedral Peak's Weir 09 YSI station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the meteorological data collected at Jonkershoek's Langrivier 800 fog station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the hydrological data collected at Cathedral Peak's CAT3 #4 station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the meteorological data collected at Cathedral Peak's 10C station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the micro meteorological data collected at Cathedral Peak's Spectral probe - IX station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the hydrological data collected at Cathedral Peak's CAT9 #6 station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the hydrological data collected at Cathedral Peak's CAT3 #1 station, as part of the South African Environmental Observation Network's monitoring projects.

An die Qualität, Wirksamkeit und Sicherheit von Arzneimitteln werden höchste Ansprüche gestellt. Zum Schutz der Verbraucher sind die Hersteller pharmazeutischer Produkte dazu verpflichtet, ein Qualitätssicherungssystem in ihren Unternehmen zu schaffen, welches in allen Bereichen die Aufrechterhaltung kontrollierter Prozesse überwacht. Dazu ist es notwendig, sämtliche Einrichtungen auf ihre Eignung und Funktion zu überprüfen. Dieser Prozess startet bereits beim Design einer neuen Anlage und endet erst mit der Stilllegung des Systems. In den Grundsätzen und Leitlinien der Guten Herstellungspraxis werden Vorgaben formuliert, wie die Qualifizierung eingesetzter Anlagen und Ausrüstungen und die Validierung der angewendeten Verfahren durchgeführt werden soll. Das Verfassen konkreter Arbeitsanweisungen, welche in allen Unternehmensbereichen verbindlich einzuhalten sind, soll einen Rahmen für die dokumentierte Umsetzung der notwenigen Schritte bieten. Die Fa. Octapharma führt die Qualifizierung neu einzurichtender Verpackungsanlagen derzeit anhand eines allgemein gültigen Arbeitsdokumentes durch, welches nicht auf verpackungstechnische Anforderungen spezialisiert ist. Um den Beschaffungsprozess zukünftiger Anlagen zu standardisieren und zu vereinfachen, sollte diese Dokumentvorlage im Zuge dieser Arbeit für die Qualifizierung von Verpackungsanlagen adaptiert werden. Neben einer Ausführung der theoretischen Hintergründe rund um das Thema Qualifizierung und den gesetzlichen Rahmenbedingungen wurde in der vorliegenden Arbeit auch auf verpackungsrelevante Anforderungen pharmazeutischer Produkte und den Verpackungsprozess näher eingegangen. Die anschließende Überarbeitung der Dokumentvorlage wurde mit der Six Sigma DMAIC-Methode abgewickelt. Über die Schritte Define, Measure, Analyze und Improve wurden Verbesserungsvorschläge für die Adaptierung der Arbeitsanweisung ausgearbeitet. The highest demands are placed on the quality, effectiveness and safety of medicinal products. To protect consumers, the manufacturers of pharmaceutical products are obliged to create a quality assurance system in their company, that monitors the maintenance of controlled processes in all areas. Therefore, all facilities have to be checked for their suitability and functionality. This process starts with the planning phase of a new plant and only ends when the system is decommissioned. The principles and guidelines of the Good Manufacturing Practice specify, how the qualification of plants and equipment and the validation of the implemented processes have to be carried out. Specific work instructions, which must be observed in all areas of the company, should provide a framework for the documented implementation of the necessary steps. The company Octapharma is currently qualifying newly installed packaging systems using a generally applicable working document, that is not specialized on packaging requirements. To standardize and simplify the procurement process of future systems, this document template should be adapted for the qualification of packaging systems in the course of this thesis. In addition to a description of the theoretical background of qualifications and the legal framework, the present work also dealt with the packaging-relevant requirements of pharmaceutical products and the packaging process. The subsequent revision of the document template was handled using the Six Sigma DMAIC methodology. Suggestions for improvement for the adaptation of the work instructions were worked out via the steps Define, Measure, Analyze and Improve.

This package contains supporting information for the hydrological data collected at Cathedral Peak's CAT9 #5 station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the meteorological data collected at VASI's Sileza station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the hydrological data collected at MSELENI's MABASA_DWAS station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the hydrological data collected at SIBHAYI's CF01B station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the hydrological data collected at VASI's SCIENCE CENTRE station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the hydrological data collected at Jonkershoek's Biesievlei station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the hydrological data collected at St. Lucia - EASTERN SHORE's WETLAND PLG station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the meteorological data collected at Cathedral Peak's 6B station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the meteorological data collected at VASI's Coastal Cashes station, as part of the South African Environmental Observation Network's monitoring projects.

In order to support the digitisation activities of DiSSCo, we have considered how best to prepare collections for digitisation, digitise them, curate their associated data, publish those data, and measure the outputs of projects and programmes. We have examined options and approaches for different types and sizes of collections, when outsourcing should be considered, and what different project management approaches are most appropriate in this range of circumstances. This report describes the approach we have taken to developing an online community-edited manual, our guidelines, other relevant resources and platforms, and a set of recommendations on how to develop and this work to enhance future digitisation capacity across DiSSCo collectionholding organisations. info:eu-repo/semantics/publishedVersion

This package contains supporting information for the hydrological data collected at Cape Agulhas's R43 Road Bridge station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the hydrological data collected at Cathedral Peak's Weir 09 station, as part of the South African Environmental Observation Network's monitoring projects.

This package contains supporting information for the hydrological data collected at St. Lucia - EASTERN SHORE's C2 PLG station, as part of the South African Environmental Observation Network's monitoring projects.