Introduction Īs a discipline, EA "proactively and holistically lead enterprise responses to disruptive forces by identifying and analyzing the execution of change" towards organizational goals. Additionally, the Federal Enterprise Architecture's reference guide aids federal agencies in the development of their architectures.
Companies such as Independence Blue Cross, Intel, Volkswagen AG, and InterContinental Hotels Group also use EA to improve their business architectures as well as to improve business performance and productivity. The United States Federal Government is an example of an organization that practices EA, in this case with its Capital Planning and Investment Control processes. These practices utilize the various aspects of an enterprise to identify, motivate, and achieve these changes." Enterprise architecture applies architecture principles and practices to guide organizations through the business, information, process, and technology changes necessary to execute their strategies.
EA APP STUDY PROFESSIONAL
The international definition according to the Federation of Enterprise Architecture Professional Organizations is "a well-defined practice for conducting enterprise analysis, design, planning, and implementation, using a comprehensive approach at all times, for the successful development and execution of strategy. For Sparx Systems Enterprise Architect, see Enterprise Architect (software).Įnterprise architecture ( EA) is a business function concerned with the structures and behaviours of a business, especially business roles and processes that create and use business data. Larger populations for use of the drug under a treatment protocol or Treatment IND Applicationįor detailed explanation of the regulations related to expanded access to investigational new drug products refer to Expanded Access.This article is about the technique/methodology. Intermediate-size patient populations (groups of patients, n >1)
Individual patients (single-patient IND applications for treatment in emergency settings and non-emergency settings) Expanded access IND applications submitted for the purpose of clinical treatment in Emergency Setting may begin as soon as the use of investigational drug is authorized by an FDA reviewing official.Īs other IND applications, expanded access IND applications may be placed by FDA on Clinical Hold.įDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for: The Investigators’ Responsibilities described for sponsors of IND applications intended for clinical investigations also apply to sponsors of expanded access IND applications intended for clinical treatment with investigational products.Īn expanded access IND application intended for IND use in non-emergency setting will go into effect 30 days after FDA receives the application or on earlier notification by FDA that the expanded access use may begin. pharmaceutical company), the treating physician is the sponsor of the expanded access IND application. In the absence of any other sponsor (e.g. The party who (1) submits a request to open an expanded access IND application and (2) receives FDA’s authorization to use the investigational product is considered the sponsor of the IND application. The expanded use of the investigational drug for the requested treatment will not interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the product. The potential patient benefit justifies the potential risks of the treatment and the potential risks are not unreasonable in the context of the disease or condition to be treated and Patient(s) have a serious or immediately life-threatening disease or condition, and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition When considering an IND application for expanded access to an investigational product with the purpose of treating a patient or a group of patients, physicians and investigators should recognize that such applications would be suitable when all of the following criteria apply: The rules and regulations related to expanded access are intended to improve access to investigational drugs for patients who may benefit from investigational therapies. Expanded access, sometimes called "compassionate use," is the use of investigational new drug products outside of clinical trials to treat patients with serious or immediately life-threatening diseases or conditions when there are no comparable or satisfactory alternative treatment options.
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