scholarly journals The Extent of Extemporaneous Preparation and Regulatory Framework of Extemporaneous Compounding in Latvia

Medicina ◽  
2019 ◽  
Vol 55 (9) ◽  
pp. 531 ◽  
Author(s):  
Olga Kiseļova ◽  
Baiba Mauriņa ◽  
Venta Šidlovska ◽  
Jānis Zvejnieks
Keyword(s):  
Pharmaceutical Preparations ◽  
Regulatory Framework ◽  
State Agency ◽  
Community Pharmacies ◽  
Medicinal Products ◽  
Microsoft Excel ◽  
Specific Patient ◽  
Safety Assurance ◽  
Extemporaneous Preparation ◽  
And Control

Background and objectives: Extemporaneous preparations are pharmaceutical preparations individually prepared for a specific patient or patient group, but also high-risk products accompanied by doubts regarding their safety and quality. Legislation regulating the compounding of extemporaneous preparations is not harmonized among European countries. This problem is partially resolved by Resolution CM/Res(2016)1 on quality and safety assurance requirements for medicinal products prepared in pharmacies for the special needs of patients. In order to understand the relevance of extemporaneous compounding in Latvia and the fulfillment of the abovementioned resolution’s requirements, it is essential to get information about the volume and breakdown of sales of extemporaneous medicinal products in community pharmacies. The purpose of this survey is to identify the sales volume of extemporaneous preparations in community pharmacies in Latvia in 2017 by analyzing unpublished data of the State Agency of Medicines (SAM), as well as comparing Latvian laws with the requirements of the resolution. Materials and Methods: A separate Microsoft Excel spreadsheet was prepared for each statistical region in order to summarize the unpublished information of SAM on the turnover of extemporaneous preparations in 2017 in all Latvian statistical regions. In order to compare the regulatory framework in Latvia with the resolution, the Latvian Pharmaceutical Law and the Cabinet of Ministers Regulations regulating prescription, compounding and control of extemporaneous preparations in community pharmacies were analyzed. Results: Only 280 of 384 pharmacies submitted a report of sales of extemporaneous preparations for 2017 to the SAM. These pharmacies represented all Latvian statistical regions. Extemporaneous preparations were mostly sold in Riga (78.93%). The Latvian regulation does not include all paragraphs of the resolution. Most of the paragraphs of the resolution are described in Latvian regulatory enactments only partially. Conclusions: The total number of compounding pharmacies evidence that the service is needed. Latvian example highlights a necessity for European Union countries to compare their national legislation with the requirements of the resolution’s last version and, if necessary, implement relevant amendments.

Regulating Religious Broadcasting

1992 ◽  
Vol 2 (10) ◽  
pp. 287-304
Author(s):  
Ian Leigh
Keyword(s):  
New Technologies ◽  
Technological Advance ◽  
Regulatory Framework ◽  
Religious Expression ◽  
Satellite Broadcasting ◽  
Religious Broadcasting ◽  
The Creation ◽  
The Uk ◽  
A Minor ◽  
And Control

The broadcasting world is currently undergoing a revolution. The new technologies of cable and, more importantly, satellite broadcasting have brought within reach an enormous potential expansion and diversity in broadcasting. The Broadcasting Act 1990 is the government's response to the challenge, creating a mostly new regulatory framework. Alongside technological advance there has been a growing concern with regulating programme quality, as the creation of the Broadcasting Standards Commission (placed by Pt. V of the Act on a statutory footing) bears witness. A minor, but not insignificant, place in these cross-currents of ferment is occupied by religious broadcasting. This article seeks to place the controls and duties relating to religious broadcasting under the new regime within the context of its history in the UK and to consider the extent to which the new legal and administrative controls achieve an acceptable balance between religious expression and control of standards.

Methodological Considerations in the Assessment of Effectiveness of Homeopathic Care: A Critical Review of the EPI3 Study

Homeopathy ◽  
2021 ◽  
Author(s):  
Yola Moride
Keyword(s):  
Critical Review ◽  
Patient Characteristics ◽  
Upper Respiratory Tract ◽  
Specific Patient ◽  
Outcome Measurements ◽  
Apparent Loss ◽  
Therapeutic Opportunity ◽  
Methodological Considerations ◽  
Tract Infections ◽  
And Control

Abstract Background  EPI3 is an observational study of a representative sample of general practitioners (GPs) and patients in France, demonstrating that patient characteristics differ according to the prescribing preferences of their GPs for homeopathy. For selected conditions (musculoskeletal disorders, sleep disorders, anxiety/depression, upper respiratory tract infections), progression of symptoms and adverse events over follow-up in the homeopathy preference group did not significantly differ from other practice preferences, but there was a two-fold to four-fold lower usage of conventional medicines. The EPI3 study's validity was challenged due to absence of head-to-head comparison of medicines to conclude on a causal association between homeopathy and outcomes. Methods A critical review of the nine EPI3 publications was conducted, focusing on generalizability, selection bias, outcome measurements and confounding. Results The conceptual framework of EPI3 rests on a systemic construct, i.e., the homeopathic treatment concept assessed using the type of GP prescribing preference, taking into account the clinical, human and social aspects. The enrollment process enhanced the generalizability of findings. Validated instruments for outcome measurements were used for three conditions, and control of confounding was rigorous. Conclusion EPI3 was conducted according to best practices. Homeopathy prescribing preference met specific patient needs with less use of conventional medicines and without an apparent loss in therapeutic opportunity.

The concept of development of the Contract System of the Ministry of Internal Affairs of Russia as a tool for effective use of budget funds and ensuring competition in the state procurement market

2021 ◽  
pp. 76-87
Author(s):  
A. A. Tsviliy-Buklanova
Keyword(s):  
Public Procurement ◽  
The State ◽  
Regulatory Framework ◽  
Structural Elements ◽  
Departmental Level ◽  
Internal Affairs ◽  
Effective Use ◽  
And Control

The article is devoted to the relevance of the development and adoption of the Concept for the development of the Contract System of the Ministry of Internal Affairs of Russia in order to increase the efficiency of using budget funds and eliminate corruption risks in the implementation of public procurement. The regulatory framework of federal and departmental level was considered, attention was paid to practical aspects of procurement of goods, works and services for the needs of internal affairs bodies, issues of regulation and control are reflected. Structural elements of the Concept, ways to improve the Contract System of the Ministry of Internal Affairs of Russia are proposed.

scholarly journals A Modular Digital Twinning Framework for Safety Assurance of Collaborative Robotics

2021 ◽  
Vol 8 ◽  
Author(s):  
J.A. Douthwaite ◽  
B. Lesage ◽  
M. Gleirscher ◽  
R. Calinescu ◽  
J. M. Aitken ◽  
...  
Keyword(s):  
Testing Strategy ◽  
Modular Architecture ◽  
Industrial Case Study ◽  
Safety Assurance ◽  
Physical Environments ◽  
Digital Twins ◽  
The Creation ◽  
Hardware Platforms ◽  
And Control

Digital twins offer a unique opportunity to design, test, deploy, monitor, and control real-world robotic processes. In this paper we present a novel, modular digital twinning framework developed for the investigation of safety within collaborative robotic manufacturing processes. The modular architecture supports scalable representations of user-defined cyber-physical environments, and tools for safety analysis and control. This versatile research tool facilitates the creation of mixed environments of Digital Models, Digital Shadows, and Digital Twins, whilst standardising communication and physical system representation across different hardware platforms. The framework is demonstrated as applied to an industrial case-study focused on the safety assurance of a collaborative robotic manufacturing process. We describe the creation of a digital twin scenario, consisting of individual digital twins of entities in the manufacturing case study, and the application of a synthesised safety controller from our wider work. We show how the framework is able to provide adequate evidence to virtually assess safety claims made against the safety controller using a supporting validation module and testing strategy. The implementation, evidence and safety investigation is presented and discussed, raising exciting possibilities for the use of digital twins in robotic safety assurance.

scholarly journals Ergonomic evaluation in community pharmacies

2021 ◽  
Vol 31 (Supplement_2) ◽  
Author(s):  
Ana Ferreira ◽  
Ana Lança ◽  
João Paulo Figueiredo ◽  
António Loureiro ◽  
Silvia Seco ◽  
...  
Keyword(s):  
Well Being ◽  
Community Pharmacies ◽  
Work Related ◽  
Risk Of Exposure ◽  
Increase In Productivity ◽  
And Control ◽  
Inference Tests ◽  
Personalized Intervention ◽  
Consequent Increase ◽  
Ergonomic Evaluation

Abstract Background The risk of a health professional contracting work-related diseases is about 1.5 times greater than the risk of all other workers. For this reason, the present study focused on community pharmacies, aiming ergonomic risks, which allows a more personalized intervention individualized in an assessment and control of ergonomic risks. Methods We proposed as an objective of this study, to evaluate the ergonomic risks to which the workers of the community pharmacies are exposed. This study was of the Descriptive-Correlational, Analytical type, and of a transversal nature where the working conditions in pharmacies of the municipality of Coimbra were evaluated. The sample being represented by 15 workers. A questionnaire was carried out and the KIM and RULA methodologies were applied for ergonomic evaluation. The results were evaluated using the IBM SPSS Statistics version 26.0 program using descriptive tests and inference tests. Results The ergonomic assessment indicated greater risk of exposure in the task of replacing goods, the perception of workers proved to be positive in relation to existing non-conformities. There were no statistically significant differences in psychosocial and ergonomic risks between men and women. Conclusion The ergonomic conditions of the workplace for the professionals in community pharmacies are unfavourable in some points. However, if they try to adapt the workplace to the worker considering ergonomic aspects, they will promote well-being and thus guarantee better performance for their professionals and consequent increase in productivity

INDIVIDUAL PREVENTION OF ESCAPES FROM SETTLEMENT COLONIES

2021 ◽  
pp. 131-136
Author(s):  
Василий Алексеевич Рудаев
Keyword(s):  
Russian Federation ◽  
Regulatory Framework ◽  
Current Application ◽  
Preventive Control ◽  
Constituent Entity ◽  
Freedom Of Movement ◽  
The Russian Federation ◽  
The Government ◽  
The Individual ◽  
And Control

В статье анализируются правовые и организационные аспекты профилактики побегов из колоний-поселений. Автор акцентирует внимание на недостатках и трудностях в обеспечении контроля и надзора за осужденными-поселенцами. Это связано с тем, что нормы пенитенциарного законодательства наделяют осужденных значительным объемом льгот в период отбывания наказания в колониях-поселениях. Отсутствие вооруженной охраны, наличный оборот денежных средств, свобода передвижения по территории колонии, использование труда осужденных на отдельных объектах в пределах субъекта Российской Федерации по месту дислокации учреждения обуславливают невозможность обеспечения должного надзора. В указанных условиях традиционные формы надзора и контроля мало результативны. Автор аргументирует эффективность использования инновационных технических средств контроля и надзора за осужденными, содержащимися в колониях-поселениях, для профилактики побегов. Однако данный вид контроля невозможно осуществлять без внесения изменений в законодательство. На основании изучения нормативной базы, регламентирующей индивидуальную профилактику правонарушений в пенитенциарных учреждениях, а также рекомендаций практических работников, автор делает вывод, что действующие нормы не отвечает современным реалиям. Автор обосновывает расширение круга подучетных лиц, с одновременным увеличением юридического значения профилактического учета посредством закрепления возможности использования технических средств контроля и надзора за ними. The article analyzes the legal and organizational aspects of the prevention of escapes from the settlement colonies. The author focuses on the shortcomings and difficulties in the government of control and supervision over convicted settlers. This is due to the fact that the norms of the penitentiary legislation endow convicts with a significant amount of benefits during the period of serving their sentences in settlement colonies. The lack of armed guards, cash circulation of funds, freedom of movement across the territory, the use of convicts' labor at certain facilities of the constituent entity of the Russian Federation at the location of the institution make it impossible to ensure proper supervision. Under these conditions, the forms of supervision and control are not very effective. The author argues the effectiveness of the use of innovative technical means of control and supervision over convicts held in settlement colonies for the prevention of escapes. However, this type of control cannot be carried out without amending the legislation. Based on the regulatory framework governing the individual prevention of offenses in penitentiary institutions, as well as the recommendations of practitioners, the author concludes that the current application of the measure does not correspond to modern realities. Use of technical means of preventive control over them.

A Regulatory Framework for Dam Safety Assurance

2020 ◽  
pp. 245-270
Author(s):  
Marcus J. Wishart ◽  
Satoru Ueda ◽  
John D. Pisaniello ◽  
Joanne L. Tingey-Holyoak ◽  
Kimberly N. Lyon ◽  
...  
Keyword(s):  
Regulatory Framework ◽  
Dam Safety ◽  
Safety Assurance

The “Smart” Regulatory Framework

2014 ◽  
pp. 58-86
Keyword(s):  
Financial Market ◽  
Self Regulation ◽  
Regulatory Framework ◽  
The Self ◽  
Regulatory Regime ◽  
Theoretical Concepts ◽  
Smart Regulation ◽  
Responsive Regulation ◽  
And Control ◽  
Regulation Mode

Based on the recognition that neither the command-and-control nor the self-regulation mode based regulation can accommodate the ever growing complexity of the financial market, this chapter argues that a new regulatory regime is needed. This chapter discusses the four theoretical concepts -- governmentality, reflexivity, responsive regulation and ‘smart’ regulation – that anchor a proposed alternative “smart” regulatory framework.

Cyber Security Assurance in the Design, Implementation, and Operation of NPP I&C Systems

2020 ◽  
pp. 323-348
Author(s):  
Oleksandr Klevtsov ◽  
Artem Symonov ◽  
Serhii Trubchaninov
Keyword(s):  
Control Systems ◽  
Cyber Security ◽  
Regulatory Framework ◽  
Nuclear Facilities ◽  
Stages Of Development ◽  
Basic Principles ◽  
Security Assurance ◽  
Security Levels ◽  
And Control

The chapter is devoted to the consideration of the issues concerning the cyber security assurance of NPP instrumentation and control systems. A brief overview of the international regulatory framework in the field of cyber security for nuclear facilities is given. The different approaches to the categorization of NPP instrumentation and control systems by cyber security are expressed. The basic principles of cyber security assurance of NPP instrumentation and control systems are considered. The specific measures of cyber security assurance (i.e., graded according to the cyber security levels) on the stages of development, implementation, and operation of NPP instrumentation and control systems are presented.

scholarly journals Phage Therapy Regulation: From Night to Dawn

Viruses ◽  
2019 ◽  
Vol 11 (4) ◽  
pp. 352 ◽  
Author(s):  
Alan Fauconnier
Keyword(s):  
Large Scale ◽  
Phage Therapy ◽  
Resistance To Change ◽  
Regulatory Framework ◽  
Global Perspective ◽  
Western World ◽  
Medicinal Products ◽  
Advanced Therapy Medicinal Product ◽  
Advanced Therapy ◽  
And Personalized Medicine

After decades of disregard in the Western world, phage therapy is witnessing a return of interest. However, the pharmaceutical legislation that has since been implemented is basically designed for regulating industrially-made pharmaceuticals, devoid of any patient customization and intended for large-scale distribution. Accordingly, the resulting regulatory framework is hardly reconcilable with the concept of sustainable phage therapy, involving tailor-made medicinal products in the global perspective of both evolutionary and personalized medicine. The repeated appeal for a dedicated regulatory framework has not been heard by the European legislature, which, in this matter, features a strong resistance to change despite the precedent of the unhindered implementation of advanced therapy medicinal product (ATMPs) regulation. It is acknowledged that in many aspects, phage therapy medicinal products are quite unconventional pharmaceuticals and likely this lack of conformity to the canonical model hampered the development of a suitable regulatory pathway. However, the regulatory approaches of countries where phage therapy traditions and practice have never been abandoned are now being revisited by some Western countries, opening new avenues for phage therapy regulation. As a next step, supranational and international organizations are urged to take over the initiatives originally launched by national regulatory authorities.

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