National Regulatory Bodies Research Articles

Protection of Nuclear Power Plants from Fraudulent Items

At present a lot of problems with fraudulent items occurred. They disrupt the safety of industry, power engineering and other objects that are important for the life of human society. The article gives infor-mation on causes of occurrence of fraudulent items in nuclear power plants and shows that protection against fraudulent items needs to perform during the whole supply chain of critical items. In detail, it concentrates to the quality of awarding terms of references, which nuclear power plant operator prepares when it gives order to commercial supplier and of process of take-over control of the deliver commodity. Due to national security, the safety of nuclear facilities is also supervised by national nuclear regulatory body. During our research we processed checklists by which national nuclear regulatory body can reveal risks in awarding the contracts to commercial suppliers and in take-over control, and ensures improve-ment of these processes.

The scholarly and practice profile of respiratory therapists in Canada: A cross-sectional survey.

Respiratory therapists (RTs) are expected to provide high-quality care for patients with chronic and acute cardiopulmonary conditions across the lifespan by staying abreast of emerging scientific evidence and effectively integrating it into clinical practice. This integration of evidence is encompassed within the competency of scholarly practice. However, there is currently a limited understanding of RTs' scholarly practice. Furthermore, despite RTs' widespread presence in the Canadian healthcare system, comprehensive studies describing the profiles of RTs are lacking. This study aimed to describe the demographic characteristics, scholarly and practice profiles of the respiratory therapy profession in Canada. A cross-sectional survey was distributed via the national professional association and regulatory bodies. The survey contained seven sections with 52 items. We calculated means and standard deviations, or medians and interquartile ranges for continuous variables and frequencies and proportions for categorical variables. Open-ended questions were analyzed using summative content analysis. We analyzed data from 832 participants (6.8% response rate) from Ontario (17.8%), Québec (15.7%), and Alberta (13.3%), and across other provinces. Nearly 40% had completed an undergraduate degree beyond their respiratory therapy diploma. Few participants had authored or co-authored peer-reviewed publications. RTs reported reading approximately 2.2 peer-reviewed publications monthly. Most participants agreed on the importance of critical reflection in practice (93.1%) and that having a supportive work environment was vital. Almost three-quarters of participants (73.4%) reported that they believe that RTs are valued members of interprofessional teams, and 78% agreed that understanding research enables them to engage in patient advocacy. This survey provides a portrait of the practice and scholarly profile of the respiratory therapy profession in Canada. While the profession shows potential for growth, concerns persist regarding limited engagement in activities related to scholarly practice. Addressing these challenges and nurturing a culture of scholarly practice are likely necessary to support the development of scholarly practice in the profession. Creating supportive environments, providing access to resources, and encouraging professional development activities may advance the scholarly practice of RTs. Future national surveys could employ random sampling strategies to achieve a more representative sample of the profession.

Micro-Credentialing and Digital Badges in Developing RPAS Knowledge, Skills, and Other Attributes

This study explores the potential of micro-credentialing and digital badges in developing and validating the knowledge, skills, and other attributes (KSaOs) required for diverse Remotely Piloted Aircraft Systems (RPAS) operations. The rapid proliferation of drone usage has outpaced the development of necessary KSaOs for safe and efficient drone operations. This research aims to bridge this gap by identifying the unique and specific KSaOs required for different types of drone operations and examining how micro-credentialing and digital badges can provide tangible evidence of these KSaOs. The study also investigates the potential benefits and challenges of implementing digital badges in the RPAS sector and how these challenges can be addressed. Furthermore, it explores how digital badges can contribute to the standardization and recognition of RPAS competencies across different national regulatory bodies. The methodology involves observational studies of publicly available videos of drone operations, with a focus on agriculture spraying operations. The findings highlight the importance of both generic and specific KSaOs in RPAS operations and suggest that digital badges may provide an effective means of evidencing mastery of these competencies. This research contributes to the ongoing discourse on drone regulation and competency development, offering practical insights for regulators, training providers, and drone operators.

Opportunities and challenges to the development and deployment of vaccines for pregnant women in Germany

Maternal immunisation is a powerful tool to protect both pregnant women and their children. A new maternal RSV vaccine holds promise to protect newborns from RSV-associated illness in the first few months of life, but no official recommendation has been made in Germany. Since RSV causes a significant burden of paediatric hospital admissions, we consider it a pertinent opportunity to review barriers to maternal vaccination in Germany, which might also apply to other settings. Access to vaccination for pregnant women in Germany is shaped by an interplay of legal, regulatory, institutional, and sociocultural factors, with a less permissive clinical research environment, delays in recommendation and roll-out, and lower acceptance by healthcare professionals and the population. Actionable recommendations to improve availability and uptake include coordination with other national regulatory bodies to reduce delays, awareness and literacy campaigns for health professionals and the general public, and capacity building for vaccine clinical research.

Bearing the weight: A qualitative study on expert views on integrating ethics in autonomous vehicles

AVs are increasingly becoming present on public roads, the ethics of which have captured the publics attention. This study represents the first ever investigation into the opinion of AV development experts on the ethics of programming AVs in collision scenarios. The study makes use of a qualitative research model. A sample of 24 Swiss experts were interviewed using semi-structured interviews. The majority of experts were directly involved in the development of AVs and represented both research, private, and public sectors as well as national regulatory bodies. Three core themes emerged from the data. 1) Experts were keenly aware of the ethical challenges involved in AVs on public roads, including in collision situations. 2) Experts felt a moral responsibility for how AVs are programmed and developed. However, experts’ moral framework was not well developed with many experts stating that their own personal moral framework should not be used to program motion planning. 3) Experts saw a need for an ethical framework to guide the development of AVs. The paper concludes that it is clear experts are keenly aware of the ethics involved in AVs on public roads, and in particular collision scenarios. They feel a sense of responsibility for how AVs are programmed but do not feel ethically well-equipped themselves. Experts would, therefore, appreciate an ethical framework that would assist the development of these algorithms. This framework may be driven by either industry or government but should be clear and simple. We recommend countries like Switzerland develop such a framework.

Dissolution profile evaluation of selected brands of amoxicillin-clavulanate potassium 625 mg tablets retailed in Hawassa town, Sidama Regional State, Ethiopia

Poor quality amoxicillin-clavulanate potassium tablets have been recently discovered in generic drugs related to Augmentin-like medicines containing amoxicillin and clavulanic acid, as well as its derivatives containing falsified active ingredients. One of the most important dosage form characteristics are a detailed active pharmaceutical ingredients dissolution release profile evaluation obtained through dissolution testing. The dissolution test is used in the development of both brand-name and generic drugs. Prior to beginning bioequivalence studies, it is critical to compare the dissolution profiles of various pharmaceutical products. As a result, dissolution is a critical quality control parameter for drugs because it has a direct impact on absorption of pharmaceutical products. Dissolution profile evaluation of seven brands of amoxicillin-clavulanate potassium tablets is retailed in Hawassa town, Sidama Regional State, Ethiopia. The seven brands of amoxicillin-clavulanate potassium tablets were collected from Hawassa town, Sidama Regional State, Ethiopia. The dissolution study was conducted as per USP40-NF35. Then, the dissolution profile test results were compared by one-way ANOVA Dunnett’s test, model independent, and model dependent method. All of the included brand tablets complied with a single-point dissolution study specification. All brand tablets had similar dissolution profiles (p > 0.05), difference factor (f1) < 15%, and dissolution efficiency (≤10%\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$(\\le 10\\varvec{\\%}$$\\end{document}). However, the f2 (similarity factor) value justifies that all brand tablets were not within USFDA specification (≥\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\ge$$\\end{document}50%). The evaluated brands followed the Korsemeyer-Peppas followed by the Weibull curve models. All brand tablets passed the single point USP dissolution specification and the USFDA therapeutic interchangeability guideline. The similarity factor (f2), on the other hand, confirmed that none of the tested brand tablets were interchangeable with the innovator product. Therefore, researchers, national medicine regulatory bodies, and the manufacturer should conduct a properly designed dissolution test as proof of an in vitro bioequivalence study supported by in vivo bioavailability data.

Exchange rate instabilities during the Russia-Ukraine war: Evidence from V4 countries

PurposeThis study investigates the impact of the Russian Ruble on the Czech crown, Polish zloty, and Hungarian forint during the Russia-Ukraine war. The euro is used as a comparative base unit in the four exchange rate parities. The Euro was used since the Czech Republic, Hungary, Poland, and Russia maintain intensive economic relations with the Eurozone. At the same time, the Visegrad (V4) countries are geographically located in the European continent and are bordered by the Eurozone member states. MethodsThe series stands in daily frequency and indicate the period from February 1, 2022, to February 1, 2023. To generate the results, the VAR impulse response function, variance decomposition, vector error correction model, and granger causality test were performed. ResultsEven though Russia demanded that gas payments be made in Rubles, this fact did not affect the Czech crown, Polish zloty, and Hungarian forint. Due to the fact that gas payments for the V4 countries were agreed in Euros through German contractors. During this period, the strong influence of the Czech crown on the Polish zloty and the Hungarian forint is observed. ImplicationsFrom a policy perspective, the results provide indications for the national governments and regulatory bodies on the implications of the Russian ruble during this conflict. In short, our findings document that the instability of currency pairs is not only economic but also geopolitical. Energy dependence on autocratic states not only endangers national security but can set exchange rates in cardiac arrest. Moreover, the geographical proximity to the conflict zone tends to be decisive in the collapse of national currencies.

Аналіз світового досвіду забезпечення фінансово-економічної безпеки суб’єктів господарювання

The article analyzes the international experience of ensuring the financial and economic security of economic entities. It is specified that the financial and economic security of an economic entity is a multidimensional dynamic system, which consists of certain internal elements that are designed to ensure the effective use of enterprise resources in each direction of its activity. It is noted that the analysis of foreign experience in ensuring the financial and economic security of economic entities reveals a variety of approaches and methods that can be useful for improving the system of financial and economic security in Ukraine. In general, foreign experience shows that the integration of a comprehensive regulatory framework, modern technologies, effective monitoring and crisis management systems, as well as regular audits and education are key elements for ensuring the financial and economic security of economic entities. The integration of these practices can significantly improve the system of financial and economic security in Ukraine, ensuring its stability and sustainability. The existing models of ensuring the financial and economic security of economic entities in different countries over the world are considered. It is determined that the system of ensuring financial and economic security in the United States is complex and integrated, with a clear division of functions between different regulatory bodies and the use of latest technologies for monitoring and management of financial risks. Thus, in each of the countries studied, financial and economic security is ensured through a combination of national regulatory bodies, international standards and practices, which allows creating a reliable and sustainable system not only of economic entities, but also of the country as a whole. It is concluded that approaches to financial and economic security may differ from country to country, but common features are the presence of specialized regulators, the role of central banks, mandatory audits and the use of stress tests. In turn, national laws, regulatory structures and approaches to crisis management cause significant differences. The study of international experience has proved that the introduction of effective methods and practices of other countries can significantly improve the system of financial and economic security in Ukraine. This may include introducing new regulatory standards, improving technology infrastructure, and increasing transparency in financial management.

Do Islamic banks use institutional theory in the light of Shariah governance? Empirical evidence from a Muslim dominant country

The present paper examines the application of institutional theory (hereafter IT) mechanisms (isomorphism and legitimacy) in Shariah governance (henceforth SG) practices and in operations, as it best illuminates the operational guidelines and procedures for the Islamic banks to attain legitimacy. More specifically, the study aims to empirically explore the SG of Islamic banks in Bangladesh from the viewpoint of IT mechanisms. The study applied a qualitative case study method and a semi-structured face-to-face (individual) interview with various stakeholders connected with Bangladesh's Islamic banks and SG practices. The study finds that Islamic banks face pressure from the administration, regulators, and government in performing their activities and functions. More importantly, most Islamic banks replicate one leading Islamic bank, which indicates the presence of mimetic or cultural-cognitive isomorphism. Conversely, normative pressure covers the existing practicing environment, people's social awareness, knowledge, willingness, and accountability of the Board of Directors (BOD) towards the people concerning Shariah compliance with policymaking. Moreover, socio-political norms, regulations, and corruption influenced policymaking, preparation of SG guidelines, and their implementation. The study significantly contributed to national regulatory bodies by exploring the presence of significant pressures on diverse stakeholders. The study has several policy contributions for the Islamic banks and the Central Bank of Bangladesh. Notably, the study will help global regulatory bodies and policymakers minimize multifaceted pressures, improve SG practices, and enhance the quality of Shariah compliance.

Hepatic Macrophages as Targets for the MSC-Based Cell Therapy in Non-Alcoholic Steatohepatitis.

Non-alcoholic steatohepatitis (NASH) is a serious public health issue associated with the obesity pandemic. Obesity is the main risk factor for the non-alcoholic fatty liver disease (NAFLD), which progresses to NASH and then to end-stage liver disease. Currently, there are no specific pharmacotherapies of NAFLD/NASH approved by the FDA or other national regulatory bodies and the treatment includes lifestyle adjustment and medicines for improving lipid metabolism, enhancing sensitivity to insulin, balancing oxidation, and counteracting fibrosis. Accordingly, further basic research and development of new therapeutic approaches are greatly needed. Mesenchymal stem cells (MSCs) and MSC-derived extracellular vesicles prevent induced hepatocyte death in vitro and attenuate NASH symptoms in animal models of the disease. They interact with hepatocytes directly, but also target other liver cells, including Kupffer cells and macrophages recruited from the blood flow. This review provides an update on the pathogenesis of NAFLD/NASH and the key role of macrophages in the development of the disease. We examine in detail the mechanisms of the cross-talk between the MSCs and the macrophages, which are likely to be among the key targets of MSCs and their derivatives in the course of NAFLD/NASH cell therapy.

Evaluating the impact of novel oncology drug coverage through patient assistance programs in British Columbia (BC), Canada.

13 Background: Despite a universal public healthcare system, Canadian oncology patients often enroll in patient assistance programs (PAPs) through drug manufacturers to access oncology drugs that are awaiting funding decisions by national and provincial regulatory bodies. Our multicenter study evaluated the pharmacoeconomic and clinical impact of PAPs for cancer patients in BC. Methods: Eligible patients were diagnosed with cancer and enrolled in a PAP for an oncology drug between January 1, 2016 - December 31, 2019 in 3 BC centres. Charts were reviewed for treatment details and survival data. We referenced median overall survival (mOS) or median progression-free survival (mPFS) data from phase III trials. mPFS data was used if mOS was unavailable or not statistically significant. For each drug indication, the hazard ratio from trial data was multiplied by the mOS or mPFS of our cohort to estimate the mOS or mPFS if the drug was not received. Life-years gained (LYG) was defined as the difference between the actual mOS or mPFS in our cohort and the estimated mOS or mPFS if the drug was not received. Mean OS was used if median OS was not reached by the cut-off date January 1, 2021. Quality-adjusted life years (QALY) and cost per drug were obtained from the Canadian Agency for Drugs and Technologies in Health (CADTH). QALY gained per drug was calculated as QALY multiplied by LYG. Assuming $100,000 Canadian dollars (CAD) for 1 QALY gained (based on prior studies), the economic value of QALY gained was calculated as $100,000 CAD multiplied by QALY gained per drug. Results: Our cohort consisted of 1025 patients that accessed 40 oncology drugs via PAP. By the cut-off date, 290 patients continued on treatment while 735 had stopped, most often due to disease progression (69%) or toxicity (14%). 74 patients then accessed another drug in their second exposure to PAP, and 5 patients accessed drugs in their third exposure to PAP. Median time from Health Canada approval to public funding was 2.04 years (IQR 1.53 – 2.34). QALY gained per drug ranged from 0.007-2.997 years for OS and 0.001-1.339 years for PFS. This translated to a total of 268.3 QALY gained in OS and 117.6 QALY gained in PFS. In the first exposure group, total economic value gained from PAP was $26,788,512 for those with OS benefits, $11,763,571 for those with PFS benefits, and total drug costs were $94,150,774. In the second exposure group, total economic value gained was $566,253 for those with OS benefits, $947,134 for those with PFS benefits, and total costs were $4,917,017. In the third exposure group, $44,754 total economic value was gained and total costs were $931,207. Conclusions: Nearly $100 million CAD of non-public funding was required to bridge gaps between regulatory approval and public funding. The economic value and QALY gained from PAPs are substantial. Future studies should focus on strategies to optimize the funding process for novel cancer therapies.

Evaluation of radiation safety levels in the monitor rooms of selected diagnostic centres in Lagos State using thermoluminescent dosimeter

The hazard of exposure to ionizing radiation at low doses has been scientifically proven to be possible for cancer and non-cancer diseases. International and national regulatory bodies have recommended dose limits for occupationally exposed workers to ionizing radiation and the general public. The objective of this study was to assess the radiation safety levels in monitor rooms of x-ray diagnostic radiology facilities. Sixty monitored rooms in twenty radio diagnostic centers were visited. Three tissue-equivalent thermoluminescent dosemeters (TLD-100 (LiF: Mg. Ti)) chips were placed in strategic places a few centimeters from the viewing glass in the monitored rooms for two weeks. The TLDs were analyzed using the RADOS RE 2000 TLD reader. Questionnaires were also distributed to ascertain compliance with the basic principles of radiation protection. The average personnel dose equivalents in the monitored rooms of conventional x-rays, mammography, computed tomography, and fluoroscopy were 0.33, 0.32, 0.28, and 0.34 mSv/year, respectively. The status of the radiation safety levels in the selected monitored rooms is satisfactory because the values obtained were below the international recommended dose limit of 50 mSv in a single year for occupationally exposed radiation workers.

EURADOS ISO/IEC 17025 guidance for IMS: suggestions on how to interpret and implement the requirements including examples from accredited laboratories.

Individual monitoring of external radiation is an activity usually regulated by national regulatory bodies in most countries. Regulations generally contain technical requirements to be met by the individual monitoring services (IMS), in order to ensure that the measurements are correct and therefore the dosimetry results are reliable. In some countries, the requirements include or even consist of the accreditation of the service according to the standard ISO/IEC 17025: 'General requirements for the competence of testing and calibration laboratories.' It is a fact that accreditation is a growing trend among European IMS as a way to guarantee confidence in their technical competence. The acceptance of the dosimetry results between countries and their indentation in the respective National Dose Registries is facilitated if laboratories conform to the ISO/IEC 17025 standard. In the framework of the activities of EURADOS (European Radiation Dosimetry Group) working group 2 'Harmonization of Individual Monitoring in Europe' and attending to the concern of many European IMS in the process of accreditation, a guide has been prepared. The purpose was to assist and encourage IMS to apply for accreditation and to share the authors' own experience with the process. The guide intends to be a practical reference for IMS on how to interpret and implement the ISO/IEC 17025 requirements to the specific activity of a personal dosimetry service for external radiation, emphasizing those aspects of special interest. It includes examples from dosimetry laboratories already accredited. The major novelties from a new edition of ISO/IEC 17025: 2017 are also identified in the guide. Finally, the guide aims to assist the auditing process, giving examples of auditor's questions and how to show evidence of compliance. The main findings are presented.

Exploring Enterprise-Wide Risk Management System in Higher Education

Abstract The purpose of this case study research paper is to provide unique and in-depth data and understanding of Enterprise-Wide Risk Management within the real-world context of a private HEI. The research presented adoption of risk management practices within a UK higher education (HE) setting that demonstrates the evolution of processes towards enterprise-wide educational governance in support of a sustainable HE sector. Effectively managing enterprise wide risk ensures sustainability is on the governance agenda. Within this research paper a wide spectrum of risk management practices and theories is assessed and a case study review shows a mature adoption, over time, of a holistic approach to managing risk. This research paper therefore, provides valuable lessons learned and gives practical guidance for policy makers, governors and senior management in Higher Education Institutions (HEIs). The case study organisation provides a best practice view of enterprise-wide risk management system taking guidance from global standards, national regulatory bodies, universities, colleges and experts in risk management from all levels. The main gap in current published knowledge presented is that the drivers for successfully implementing sustainable risk management in the HE sector are not known. The research questions have led the inquiry to provide three contributions to a better understanding of adopting Enterprise-Wide Risk Management in HE with a new roadmap for implementation; thematic direction for governance; and six drivers for successfully implementing sustainable risk strategies.

Retrospective Analysis of Treatment Time Calculation Agreement Between TPS and Manual Method and Source Strength Verification for 13 HDR Ir-192 Sources In Flexitron Brachytherapy Unit: A Single Institute Experience

Introduction: Source strength measurement and verification during every source exchange in high dose rate (HDR) Brachytherapy 192Ir is primary part of quality assurance program as recommended by national regulatory body Atomic Energy Regulatory Board, Mumbai, India. The purpose of this study was to evaluate RAKR (in-house measurement) of 192Ir using re-entrant well-type ionization chamber with stated RAKR values as provided by the manufacturer in source certificate and to check the accuracy of the Oncentra treatment planning system calculation with manual method of computation at different intervals for 13 HDR Ir-192 sources. Materials And Methods: We have retrospectively evaluate the in-house measured RAKR with the calibrated Standard Imaging HDR 1000 PLUS Well chamber /electrometer CDX 2000B for 13 HDR Ir192 sources with stated RAKR and the treatment time calculation accuracy of Oncentra TPS verified by manual method of computation using TG-43 formalism. Results: The study shows, that the measured RAKR and stated RAKR were well within the tolerance limits set by the national and international recommendations i.e. ±3 % for 13 HDR Ir192 sources. The verification of TPS treatment time calculation with manual calculation for single source as well as for multi-source lies within ±2%. Conclusions: There is good agreement between in-house measured and vendor quoted values of RAKR which shows that the chamber has been stable to better than ±3 % and manual calculations shows agreement with the TPS outcome within ±2% for 13 HDR Ir192 sources. The manual method of computation works reliably and reassures the TPS functioning.

Institutional capacity to prevent and manage research misconduct: perspectives from Kenyan research regulators

BackgroundResearch misconduct i.e. fabrication, falsification, and plagiarism is associated with individual, institutional, national, and global factors. Researchers' perceptions of weak or non-existent institutional guidelines on the prevention and management of research misconduct can encourage these practices. Few countries in Africa have clear guidance on research misconduct. In Kenya, the capacity to prevent or manage research misconduct in academic and research institutions has not been documented. The objective of this study was to explore the perceptions of Kenyan research regulators on the occurrence of and institutional capacity to prevent or manage research misconduct.MethodsInterviews with open-ended questions were conducted with 27 research regulators (chairs and secretaries of ethics committees, research directors of academic and research institutions, and national regulatory bodies). Among other questions, participants were asked: (1) How common is research misconduct in your view? (2) Does your institution have the capacity to preventresearch misconduct? (3) Does your institution have the capacity to manageresearch misconduct? Their responses were audiotaped, transcribed, and coded using NVivo software. Deductive coding covered predefined themes including perceptions on occurrence, prevention detection, investigation, and management of research misconduct. Results are presented with illustrative quotes.ResultsRespondents perceived research misconduct to be very common among students developing thesis reports. Their responses suggested there was no dedicated capacity to prevent or manage research misconduct at the institutional and national levels. There were no specific national guidelines on research misconduct. At the institutional level, the only capacity/efforts mentioned were directed at reducing, detecting, and managing student plagiarism. There was no direct mention of the capacity to manage fabrication and falsification or misconduct by faculty researchers.We recommend the development of Kenya code of conduct or research integrity guidelines that would cover misconduct.

SYSTEM OF PHYSICAL PROTECTION DURING TRANSPORTATION OF SOURCES OF IONIZING RADIATION OF THE FIRST CATEGORY

The discovery of radioactivity by Antoine Henri Becquerel in 1896 was a major achievement. Today, radioactive substances are used in medicine, agriculture, heavy industry, and power generation. But while radioactivity has a wide range of useful applications, this discovery also has a flip side - the misuse of ionizing radiation that can lead to burns, radiation sickness, death, cancer, tumors and genetic mutations. A source of ionizing radiation (IRS) is a physical object containing radioactive material or a technical installation that generates or is capable of generating ionizing radiation under certain conditions. In order to ensure compliance with the permissible limits of radiation exposure of people, the population and the natural environment, as specified in codes, rules and safety standards, there is a national regulatory body. In Ukraine, since 2007, state registration of sources of ionizing radiation has been a part of licensing activities in the field of nuclear energy use. Those radioactive sources that are not or have never been under regulatory control, or are left unattended, lost, misplaced, diverted without proper government authorization, or stolen, are called "abandoned sources." The problem with "abandoned sources" is their potential danger to public health and the difficulty of detection. As a rule, sources of ionizing radiation are located in metal containers with thick walls, which makes it difficult to identify the presence of a radioactive source inside with the help of appropriate equipment. Furthermore, they are objects of different shapes and sizes, and as such they are often objects of interest to different groups of people with different purposes. Getting an "abandoned source" into the hands of ordinary citizens can have catastrophic consequences. An example of a similar situation is the radioactive contamination of the Brazilian city of Goiânia in 1987. After the theft, the perpetrators dumped radiation therapy equipment components containing the radioactive isotope cesium-137 into the trash. Later, this source was discovered by a local resident, whose actions and careless handling led to the spread of radioactive contamination, as a result of which four people died from radioactive contamination, and the area where this source is located is not suitable for life. the next 300 years.

Abstract 18: Cervical Cancer Prevention and Control in the Pacific: A Comprehensive Systems Based Approach in Yap State, Federated States of Micronesia

Abstract Purpose: The US Affiliated Pacific Islands, is composed of 3 US Territories (Guam, American Samoa, Commonwealth of the Northern Marianas) and 3 Sovereign Nations (Federated States of Micronesia (FSM), Republic of the Marshall Islands, Republic of Palau. The cervical cancer incidence in several of these island nations are amongst the highest globally. This project is designed to implement a sustainable comprehensive cervical cancer (CC) control program to eliminate CC in the island nations. Yap State, FSM an LMIC is a current project site. Planning, over 7 years, was through the Cancer Council of the Pacific Islands. Funding is primarily through a CDC Prevention and Control Capacity Building Grant, and other grant funds. To eliminate cervical cancer in Yap State, FSM through enhanced evidence based public health practices. The primary objective is to increase sustainable capacity to control cervical cancer. Methods: This non-research project is guided by the principles of community-based participatory development/engagement (CBPE), implementation science, transdisciplinary approach, and capacity building. The team is composed of 4 working cores, coordinated and led by an implementation core. The 4 cores are 1.) medical protocol and laboratory support 2.) community engagement and outreach 3.) data and informatics 4.) medical modeling and micro-costing. Capacity building through training and infrastructure development is a key component. Each core works synergistically and interfaces with the Yap Community Advisory Board, which has decision making authority. Results: Working towards cervical cancer control in a small island LMIC nation, with human resource and health infrastructure limitations, geographic challenges require flexibility and patience. The project processes involve multiple iterations, are culturally/geographically nuanced, and requires constant adjustment to national and international agency and medical regulatory bodies. Strong partnerships with health policy leaders, vaccination programs, clinicians is essential. Modelling projections to understand potential outcomes is necessary. Conclusions: Cervical Cancer Prevention and Control in Yap State, FSM an LMIC can be done with close and trusting community engagement that is participatory and capacity building. Building strong relationships with local, national, and international programs necessary. Citation Format: Neal Palafox, James Edilyong, Martina Reichhardt. Cervical Cancer Prevention and Control in the Pacific: A Comprehensive Systems Based Approach in Yap State, Federated States of Micronesia [abstract]. In: Proceedings of the 11th Annual Symposium on Global Cancer Research; Closing the Research-to-Implementation Gap; 2023 Apr 4-6. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(6_Suppl):Abstract nr 18.

Effectiveness of online trainings on radiation protection in the context of the COVID-19 pandemic.

Over 212 healthcare professionals from the country have used the online trainings on radiation protection conducted during the COVID-19 pandemic. Each training, lasting up to 10 working days, is accompanied by mandatory Google Form-based questionnaires, which includes topic key questions about each lecture as well as pre- and post-training tests and provided to participants. In addition, the ability to conduct a dialogue with patients about radiation risks, group discussions, as well as a special module for radiation protection officers were assessed online. The trainings also allow participants to focus on the most important issues from their point of view in their daily work, indicating them in pre-tests, allowing the trainers to conduct lectures more adequately for each group of participants. Analysis of the tests have shown that online training is not inferior in efficiency to face-to-face training and national regulatory body received an improved opportunity to indirectly assess this efficiency.

Uncovering the gray zone: mapping the global landscape of direct-to-consumer businesses offering interventions based on secretomes, extracellular vesicles, and exosomes

BackgroundThe last decade has seen a significant increase in media attention, industrial growth, and patient interest in stem cell-based interventions. This led to a rise in direct-to-consumer businesses offering stem cell “therapies” for multiple indications with little evidence of safety and efficacy. In parallel, the use of stem cell secretomes as a substitute for stem cell transplantation has become an increasing trend in regenerative medicine with multiple clinical trials currently assessing their efficacy and safety profile. As a result, multiple businesses and private clinics have now started to exploit this situation and are offering secretome-based interventions despite the lack of supporting data. This poses significant risks for the patients and could lead to a credibility crisis in the field.MethodsInternet searches were used to locate clinics marketing and selling interventions based on stem cell secretomes, exosomes, or extracellular vesicles. Data were extracted from websites with a particular focus on the global distribution of the businesses, the cellular source of the secretome, the indication spectrum, and the pricing of the provided services. Lastly, the types of evidence used on the websites of the businesses to market their services were extracted.ResultsOverall, 114 companies market secretome-based therapies in 28 countries. The vast majority of the interventions are based on allogenic stem cells from undisclosed cellular sources and skin care is the most marketed indication. The price range is USD99–20,000 depending on the indication.ConclusionsThe direct-to-consumer industry for secretome-based therapies appears to be primed for growth in the absence of appropriate regulatory frameworks and guidelines. We conclude that such business activity requires tight regulations and monitoring by the respective national regulatory bodies to prevent patients from being conned and more importantly from being put at risk.