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Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
Historically, most classes of technical documentation lacked universal conformity for format, content and structure. Standards are being developed to redress this through bodies such as the International Organization for Standardization(ISO), which has published standards relating to rules for preparation of user guides, manuals, product specifications, etc. for technical product documentation.
Technical assistance by phone is available via a toll free number, but trying to correct problems using the phone system can be difficult and time-consuming. [20] Cathy Boeck, a past president of the Dermatology Nurses Association, said "Nurses are having the same frustrations as doctors regarding difficulties of getting the drug to patients ...
Often the data are contained in 'records' of various forms, such as on paper, microfilms or digital media. Hence technical data management is also concerned with record management involving technical data. Technical document management systems are used within large organisations with large scale projects involving engineering. For example, a ...
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation.
Common technical document summaries. Quality. Nonclinical study reports. Clinical study reports; A full table of contents could be quite large. There are two categories of modules: Regional module: 1 (different for each region; i.e., country) Common modules: 2–5 (common to all the regions) The CTD defines the content only of the common modules.
A risk management plan is a document to foresee risks, estimate impacts, and define responses to risks. It also contains a risk assessment matrix.According to the Project Management Institute, a risk management plan is a "component of the project, program, or portfolio management plan that describes how risk management activities will be structured and performed".
A technical file is a set of documents that describes a product and can prove that the product was designed in accordance with the requirements of a quality management system. All products that have a CE mark must have a technical file which must contain the information that proves that the product conforms with the EU directives and ...