• Title/Summary/Keyword: Approval Process

Search Result 252, Processing Time 0.03 seconds

Vaccines development in India: advances, regulation, and challenges

  • Rakshita Salalli;Jyoti Ram Dange;Sonia Dhiman;Teenu Sharma
    • Clinical and Experimental Vaccine Research
    • /
    • v.12 no.3
    • /
    • pp.193-208
    • /
    • 2023
  • One of the most significant medical advancements in human history is the development of vaccines. Progress in vaccine development has always been greatly influenced by scientific human innovation. The main objective of vaccine development would be to acquire sufficient evidence of vaccine effectiveness, immunogenicity, safety, and/or quality to support requests for marketing approval. Vaccines are biological products that enhance the body's defenses against infectious diseases. From the first smallpox vaccine to the latest notable coronavirus disease 2019 nasal vaccine, India has come a long way. The development of numerous vaccines, driven by scientific innovation and advancement, combined with researcher's knowledge, has helped to reduce the global burden of disease and mortality rates. The Drugs and Cosmetics Rules of 1945 and the New Drugs and Clinical Trials Rules of 2019 specify the requirements and guidelines for CMC (chemistry, manufacturing, and controls) for all manufactured and imported vaccines, including those against coronavirus infections. This article provides an overview of the regulation pertaining to the development process, registration, and approval procedures for vaccines, particularly in India, along with their brief history.

The Analysis of the security requirements for a circulation of the classified documents (비밀문서유통을 위한 보안 요구사항 분석)

  • Lee, Ji-Yeong;Park, Jin-Seop;Kang, Seong-Ki
    • Journal of National Security and Military Science
    • /
    • s.1
    • /
    • pp.361-390
    • /
    • 2003
  • In this paper, we analyze the security requirement for a circulation of the classified documents. During the whole document process phases, including phases of drafting, sending/receiving messages, document approval, storing and saving, reading, examining, out-sending and canceling a document, we catch hold of accompanied threat factors and export every threat factors of security. We also propose an appropriate and correspondent approach for security in a well-prepared way. Last, we present the security guidelines for security architecture of the classified documents circulation.

  • PDF

Implementing Visualization and GIS Techniques in Highway Projects (도로설계를 위한 3차원모델링과 GIS)

  • 강인준;이준석;김희규;이용희
    • Proceedings of the Korean Society of Surveying, Geodesy, Photogrammetry, and Cartography Conference
    • /
    • 2003.04a
    • /
    • pp.327-330
    • /
    • 2003
  • In this study a framework for cost effective visualization application is presented. Visualizations of a complex street rehabilitation and a highway interchange project are performed. The visualized products were presented to political and community groups, which significantly expedited the consensus building and project approval process.

  • PDF

An Extraction of Inefficient Factors and Weight for Improving Efficiency of the Curtain wall Life Cycle Process (커튼월 Life Cycle Process의 효율성 향상을 위한 비효율 요인 밑 중요도 도출)

  • Jung Soon-Oh;Kim Yea-Sang;Yoon Su-Won;Chin Sangyoon
    • Korean Journal of Construction Engineering and Management
    • /
    • v.6 no.4 s.26
    • /
    • pp.101-112
    • /
    • 2005
  • Recently, a curtain wall construction is a exterior finishing components which is most used for shortening time in high-rise building as well as the class of key management factors in cost and schedule control. Also, it is recognized that an effective management for curtain wall process is a major subject to accomplish the project successfully. However, as the current management for curtain wall construction is focused on the construction stage, it makes problems such as errors in business performance, rework by mistakes and duplications, errors and omissions by ineffective information management and there has never been any efficient management from a view of the entire Curtain Wall Life-cycle process. Therefore, the aim of this study is to suggest a stage check point for process improvement in the curtain wall Life-cycle process through current curtain wall process analysis, and then to investigate the cause of waste factors using the Muda method from the Toyota Production System and extract the weighted effects of the waste factors using the analytical hierarchy process method. According to the result, Most of the inefficient factors happened in architectural design stage of the entire curtain wall Life-cycle process and my research identified that detail factors of them are a delay of decision making and an approval in changes, a deficit of engineering capacity and a delay of approval in architectural design drawings by owner, etc.

A Study on the Application of Elliptic Curve Cryptography to EMV (타원 곡선 암호의 EMV 적용에 관한 연구)

  • Kim, Woong;Lim, Dong-Jin
    • Proceedings of the KIEE Conference
    • /
    • 2005.05a
    • /
    • pp.269-271
    • /
    • 2005
  • EMV was formed in February 1999 by Europay International, MasterCard International and Visa International to manage, maintain and enhance the EMV Integrated Circuit Card Specifications for Payment Systems as technology advances and the implementation of chip card programs become more prevalent. The formation of EMV ensures that single terminal and card approval processes are developed at a level that will allow cross payment system interoperability through compliance with the EMV specifications. A credit card environment of the domestic market adopted the standard Local-EMV to have the compatibility with EMV international standard and the EMV migration have been carried out b,# the step-by-step process. It may be possible to adopt various kinds of cryptographic algorithms, however, RSA public key algorithm is currently used. In this paper, as a public key algorithm for the authentication process, Elliptic Curve Cryptographic algorithm is applied to the EMV process. Implementation results is shown. and the possible changes necessary to accommodate Elliptic Curve Cryrtography is proposed.

  • PDF

An Examination of Variables Influencing Beliefs about Intellectual Ability (지적능력신념 영향 변인 탐색 - 학업관련태도, 성취목표, 가정의 심리적 환경을 중심으로-)

  • Kim, Ok-Boon;Kim, Hye-Jin
    • Korean Journal of Child Studies
    • /
    • v.32 no.2
    • /
    • pp.1-13
    • /
    • 2011
  • This research exercise was undertaken in order to examine whether academic achievement, academic attitudes, achievement goals, and family process had an influence on beliefs about intellectual ability. The subjects were 434 junior-high school students in Seoul and Incheon. The results of this study indicated that 162 students with incremental beliefs had higher scores in all five sub-factors of academic attitudes, two sub-factors in their achievement goals (namely their mastery goals and approach performance goals), and four sub-factors of family process (closeness, monitoring, communication, and approval) than 155 students with entity beliefs. The results of the binary logistic regression analysis revealed that academic self-perceptions, attitudes towards teachers, goal values, approach performance goals, closeness, and communication factors significantly affected beliefs about intellectual ability.

A Study on the Feasibility of the Timing for the Implementation of Energy-Saving Plan of Buildings Based on the Approval of Business Plan and Construction Permit (건축물에너지절약계획서의 사업계획승인, 건축허가에 따른 적용시점의 타당성 연구)

  • Kim, Dae-Won;Kim, Young-Il;Chung, Kwang-Seop
    • Journal of Energy Engineering
    • /
    • v.21 no.3
    • /
    • pp.265-270
    • /
    • 2012
  • The delay in the construction permit for the building, which obtained the approval of business proposal, may lead to a difference in the maintenance cost ranging between 20% and 30% in the neighborhood where the residents moved in, along with the new project under construction in the surrounding area amidst rigorous regulations that aim to promote energy-saving and the heightened interest of the public in energy conservation, and such problem would become the major source of serious public complaints. Thus, the energy-saving plan needs to be prepared when the approval is granted to the business plan. In order to prevent public complaints or ensure effectiveness of government's energy plan, it may be effective to apply the energy-saving plan based on current standards upon the award of construction permit when two years have elapsed since the date of the scheduled commencement of construction or when the start of construction is delayed as stipulated in the Article 18 of the Enforcement Decree of Housing Act. If the energy-saving plan and related technologies are merely the parts of license and permit process without fully serving their purposes and functions, it would be waste of time to deploy a lot of workforce and review and seek consultation. The government or owners of buildings need to fully understand the energy-saving aspects and exert effort to enhance the energy efficiency of buildings.

A Comparative Study Between the Approved Maintenance Organizations for MROs of FAA and EASA (FAA와 EASA의 MRO 조직인증제도에 대한 비교연구)

  • Kim, Jo-Bok;Lee, Jin;Hurr, Hee-young
    • Journal of the Korean Society for Aviation and Aeronautics
    • /
    • v.25 no.3
    • /
    • pp.123-134
    • /
    • 2017
  • In order to advance into the MRO industry, the Aviation maintenance organization with suitable for the standards for personnel, facilities and operations should be first approved by FAA and EASA. The purpose of study is designed to arrange the standards required for personnel, facility, operation rule for approval of Repair Station maintenance organizations certified by FAA PART 145 of the US Federal Aviation Regulation. Also to consider the following differences through the comparative analysis with domestic AMO certification of the information in the Management, Maintenance Process, and Quality System for approval of maintenance organization authorized, the additional EASA PART 145. As a comparative analysis on maintenance organization certification in the country between FAA and EASA, this study could show us that domestic maintenance organization, certified manual contents are used by applying just many of the FAA system. And we could know that as part of the EASA maintenance organization certification process, airmen personnel were relatively systematically segmented and controlled. For domestic maintenance organization certification, operational as policy implications we would like to present policy implications such as the implication of rating system of Aviation Mechanic License like EASA, the financial support of the training center to resolve the shortage of the FAA or EASA license holders, operational organization as "CAMO" for systematic aviation mechanic certified system should be required, continued construction of hangar or MRO for airworthiness repair under Governmental support, and varied application of DER system from FAA accordingly.

A Study of Document Creation and Management in Braille Libraries (점자도서관의 문서 생산과 관리에 관한 연구)

  • Seok, Jeong Eun
    • The Korean Journal of Archival Studies
    • /
    • no.40
    • /
    • pp.181-223
    • /
    • 2014
  • This study aims to present a Braille Library document creation and management status, and to identify ways to improve. This research field surveys and interviews were conducted three institutions, the quality requirements of the ISO 15489 standards. As a result, the Braille Library document management improvement plan is as follows. First, the policy and regulatory maintenance is needed. Copy of the regulations on the creation and management, access rights and related document management policies should be developed. Second, the document creation process needs to be improved. Electronic approval system responsible for the creation of persons who are visually impaired, visually impaired people can read documents created during document creation, and introduced measures and braille labels on the files attached to will have to be prepared. Third, the document management process needs to be improved. Changes in the creation copy of the records, and preserved along with the preservation of the original and the copy to have the same period, appointed to manage one set of all copies of the authentic copy of the plan is also required. Finally, for document management system should be introduced. Systematic document management system that can be introduced is required. This system will be designed to be accessible to the visually impaired, the search.