Comparison of regulatory approval process for vaccines development and manufacturing in India & USA

The Vaccine Development is a complex and time-consuming process because of stringent quality assessment procedures. The vaccine is approved for release into the market, a stringent regulatory procedure to assess quality, efficacy and safety must be maintained. The regulation of vaccine in India with the licensing and GMP is controlled by the drug controller general of India (DCGI). The USA regulation was controlled by the USFDA in center biologics evaluation and research committee (CBER) and Biologics license application (BLA). These Authorities are responsible for vaccine regulations in India & USA. The current review articles highlight the comparison of registration process of vaccines in INDIA and USA.

Regulatory Procedure of Post Approval Changes and Comparative Requirements of EU and USA Regulatory Regions

Aim: The current research paper describes the “Regulatory procedure of post approval changes and comparative regulatory requirement of EU and USA regulatory regions”. Study Design: The present study is a type of Retrospective analysis of Regulatory requirements and the reviewed data was subjected to systemic review. Understanding of the same led to several observations regarding regulatory requirements of EU and USA regulatory regions. Place and Duration of Study: The present study was carried out at Amneal Pharmaceutical Ltd., Ahmedabad, Gujarat, India from January, 2021 to April, 2021. Methodology: Several guidelines were profoundly reviewed to compare the requirements of post approval changes in EU and USA regulatory regions. Various regulatory review aspects were focused i.e. requirements for manufacturing sites addition/or Transfer, process parameters, container and closures, packaging and labelling of medicinal products. Results: The post approval changes in manufacturing sites of solid or semisolid dosage form considered as a major change for USA while considered as Moderate change for EU. The transfer of manufacturing section is major variation for USA while it is a minor but immediate inform type for EU. Change in manufacturing processes, containers, labelling section of sterile products considered as major variation for both. Semisolid and solid categories are falling under the same type of variation for EU and USA regulatory regions. Conclusion: This work demonstrated that the drug approvals in US, EU are the most demanding globally and the available guidance and procedures for the triggered changes are clear in both countries. Applicant should have scientific rationale to any change pertaining to Approved product ; Since the all change control are falling under the scope of Audit, so Applicant should maintain the all the records online.

Legal Issues of Annulment of Licenses of Professional Participant on Securities Market

The article reveals the legal issues of annulment of licenses of professional participant on securities market on the basis of the application submitted by the owner of the securities market license. The author considers the main provisions of the procedure of annulment of the securities market licenses and suggests some directions of development of regulations of annulment of securities market licenses in order to ensure the effective collaboration between the professional market participant on securities market and the Bank of Russia. In order to optimize the existing procedure the author suggests to change the way of submission of the application and all applicable materials, to change the calculation of mandatory term for review of application by the regulator and specify the regulatory reporting being a basis for the decision of the regulator on compliance with regulatory procedure set out for annulment of securities market licenses.

The Specifics of the Legal Regime of the Civil Legal Relations Objects Functioning (Theoretical Aspect)

The paper analyzes the current state of development of the concept of the legal regime and its features in the legal literature. It is indicated that the key phrase “regulatory procedure” is not fully consistent with the definition of the legal regime. Wider approaches to understanding the phenomenon of the concept of “legal regime” in the form of a functional characteristic of the operation of law are proposed. It is noted that to describe the features of the legal regime, researchers often and haphazardly use individual qualitative characteristics that do not fully reveal the meaning of the definitions of both the legal regime and its individual attributes. The author clarifies the difference between the characteristics of “special” and “particular”, “specialized” and “specific” in relation to civil legal relations. The conclusion is drawn on the need for legislative consolidation of the revealed differences and the establishment of two types of legal regimes — the legal regime of activity and the legal regime of the operation of an object. Based on the conducted structural study, the author formulates the definitions for the legal regime and civil law regime.

EXPERT RESEARCH OF AIR INCIDENTS AND INCIDENTS IN FORENSIC PRACTICE

The article is devoted to the problems of one of the types of forensic engineering expertise, namely the aircraft engineering expertise. In the light of the growing number of aircraft operating in the airspace of Ukraine, the increasing intensity of air traffic, as well as the specifics of the Ukrainian air fleet, the relevance of forensic aviation technical expertise is getting extremely high. At present, there is virtually no relevant expert specialization and all studies are conducted by forensic experts who have the relevant aviation technical education with the involvement of experts as forensic experts in the field of flight operation, repair and maintenance of aircraft, meteorologists, airfield support, ground support of flights, etc. Summarizing the expert practice of conducting forensic examinations on aviation incidents, the authors of the article point out the urgent need to create an appropriate expert specialty, which in turn involves making changes to the regulatory documents that govern the procedure for appointment and conducting forensic examinations. To provide an adequate level of justification, the necessity of creating an appropriate expert specialty, the authors briefly describe the subject and objects of the aviation technical expertise, as well as provide an indicative list of issues to be addressed by this expertise that are solved by this expert examination. Regarding the methodological support for the implementation of aviation technical expertise, the authors proposed, in their opinion, the most rational method of ensuring proper examination is the creation on the basis of the regulatory procedure for investigating aviation incidents by regulatory documents of ICAO, taking into account the national procedural legislation of Ukraine. The established methodology in its essence should be a universal document describing the main stages of the expert research – it should be step by step instructions. In future, in addition to the established methodology of aviation technical expertise, narrowly focused methodical recommendations can be added that detail the procedure of examination of certain types of aircraft or their systems and assemblies. Key words: jurisprudence, expert research, aviation incident.

Die §§ 164, 165 AO als besondere Nebenbestimmungen zum Steuerbescheid

Handling mass cases, tax law faces the difficulty of balancing the principles of legal certainty and legal correctness fairly. In order to achieve this, tax authorities may employ tax assessments subject to review (sec. 164 of the AO, Germany’s fiscal code) and provisional tax assessments (sec. 165), both of which are applied in millions of cases each year. Taking these sections’ great importance into account, the author analyses these two legal institutions in detail in this study, while also discussing the legal foundations of ancillary provisions in the field of tax law. This dissertation’s main concern is to highlight the exact regulatory content of both the proviso of reviewing a case and notice of provisional status, and to illustrate what it means in terms of regulatory procedure when the review proviso is cancelled or a provisional tax assessment is declared final by the tax authorities. Moreover, the author drafts proposals to improve sec. 164, 165 of the AO.

Provide a data mining algorithm for text classification based on text content emotions using neural network

One of the newest areas of research is in data mining and text mining is automatic discovery of knowledge from semi-structured text. an important application of data mining in the classification texts.neural networks have emerged as a powerful tool in the classification of the content of texts and a promising alternative to conventional methods of classification. in this study, by combining and improving the regulatory procedure parameters weighted binary artificial neural network model, we will provide an algorithm to classify content. This algorithm content of the texts of the Persian texts will be based on the polarity of emotion suitable performance and high accuracy. The proposed algorithm is implemented using the simulation software MATLAB and evaluated collected over 1200 comments in Farsi in the real environment. The results above show that the proposed algorithm is a neural network classification accuracy of 96% negative polarity and positive polarity sentences based on document content.

Ceremonial Religioso en la Catedral de Cuenca durante la Semana Santa a mediados del siglo XVII /Religious ceremony at the Cathedral of Cuenca during Easter to mid-seventeenth century

Resumen:La Semana Santa, ha sido uno de los raros casos de la literatura religiosa en la que pueda dar cabida a un posible procedimiento privilegiado que posibilita el uso de las normas reguladoras de los Ceremoniales eclesiásticos. Este trabajo pone en antecedentes, la importancia de este instrumento normativo, como son los Ceremoniales, para la consecución de los fines ejercitados por el organismo encargado de conseguir tales objetivos, y que no son otros que normativizar los actos religiosos que acontecen en dos de los días más señalados en España, cuales son el Jueves y el Viernes Santo. En relación a la localización del material de nuestro objeto de estudio, hay que hacer notar, que dentro de los trabajos que versan sobre los Ceremoniales eclesiásticos del siglo XVII, no consta en la actualidad una monografía, sino sólo referencias, que aborden el examen que se hace aquí. Para el estudio de este trabajo, hemos estudiado en los manuscritos existentes en la Biblioteca Nacional.Abstract: The Holy Week, it has been one of the rare cases of the religious literature in the one that could give content to a possible privileged procedure that makes possible the use of the regulatory procedure of the Ceremonial ecclesiastics. This work puts in precedents, the importance of this normative instrument, since they are the Ceremonial ones, for the attainment of the ends exercise for the organism entrusted to obtain such aims, and your that are not others that normativizar the religious acts that happen in two of the days most indicated in Spain, which are the Thursday and the Good Friday. In relation to the location of the material of our object of study, it is necessary to make notice, that inside the works that turn on the Ceremonial ecclesiastics of the 17th century, a monograph does not consist at present, but only you index, that approach the examination that is done here. For the study of this work, we have studied in the existing manuscripts in the National Library.

Ceremonial y loables costumbres de la Catedral de Cuenca durante la Semana Santa en el año 1617/Ceremonial and coomendable customs of the Cathedral of Cuenca during the Holy Week in the year 1617

La Semana Santa, ha sido uno de los raros casos de la literatura religiosa en la que pueda dar cabida a un posible procedimiento privilegiado que posibilita el uso de las normas reguladoras de los Ceremoniales eclesiásticos. Este trabajo pone en antecedentes, la importancia de este instrumento normativo, como son los Ceremoniales, para la consecución de los fines ejercitados por el organismo encargado de conseguir tales objetivos, y que no son otros que normativizar los actos religiosos que acontecen en dos de los días más señalados en España, cuales son el Jueves y el Viernes Santo. En relación a la localización del material de nuestro objeto de estudio, hay que hacer notar, que dentro de los trabajos que versan sobre los Ceremoniales eclesiásticos del siglo XVII, no consta en la actualidad una monografía, sino sólo referencias, que aborden el examen que se hace aquí. Para el estudio de este trabajo, hemos estudiado en los manuscritos existentes en la Biblioteca Nacional.The Holy Week, it has been one of the rare cases of the religious literature in the one that could give content to a possible privileged procedure that makes possible the use of the regulatory procedure of the Ceremonial ecclesiastics. This work puts in precedents, the importance of this normative instrument, since they are the Ceremonial ones, for the attainment of the ends exercise for the organism entrusted to obtain such aims, and your that are not others that normativizar the religious acts that happen in two of the days most indicated in Spain, which are the Thursday and the Good Friday. In relation to the location of the material of our object of study, it is necessary to make notice, that inside the works that turn on the Ceremonial ecclesiastics of the 17th century, a monograph does not consist at present, but only you index, that approach the examination that is done here. For the study of this work, we have studied in the existing manuscripts in the National Library.