Post-Market Surveillance
Ontology-based specification and generation of search queries for post-market surveillance
... This feature fosters transparency of a systematic search and repeatability, which is a legal imperative in the post- market surveillance of medical devices. Additionally, BfArM’s Research group ...
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Post-market surveillance Trends in Europe and industry perspectives at EU and Global Level
... Our industry considers vigilance reporting and post-market surveillance vital to the continued performance and safety of medical devices placed.. on the market at European and global[r] ...
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A Policy Analysis to Inform Options for Medical Device Regulation and Post-Market Surveillance in the Canadian Context
... Proposed Post-Market ...the post-market surveillance changes that Health Canada is proposing involve the use of mandatory reporting from hospitals and the expansion of the CMDSN which ...
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Safety of Pilocarpine Therapy in Patients With Sjögren’s Syndrome: A Single-Arm Interventional, Post-Market Surveillance Study
... Sjögren’s syndrome is a systemic immune disease with impaired secretion of salivary glands; thus, it may cause inconvenience in patients’ daily lives. Pilocarpine is a non-selective muscarinic receptor agonist used to ...
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Aortic root surgery with the CARDIOROOT vascular graft: results of a prospective multicenter post-market surveillance study
... Background: Sparing Aortic Valve procedure requires to reproduction of the geometry of the physiologic anatomy of the aortic root. Thus, the materials adopted may make a difference. CARDIOROOT is a one-piece ...
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Report. European Co-ordinated Post Market Surveillance Operation under COEN authority. Blood Glucose Meters
... This situation lead COEN to approve a protocol for coordinated post market surveillance operation in September 2008 and to approve a new work item for blood glucose meters. The protocol was approved ...
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Post-Market Surveillance Study of a Skull Flap Fixation Device: Cranfixer
... Table 1 presents patient demographics: gender, age, follow-up duration, number of Cranfixers used, size of bone flap, location of bone flap in the skull, patient’s dis- ease, fl[r] ...
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The performance of sequence symmetry analysis as a tool for post-market surveillance of newly marketed medicines: a simulation study
... Sequence Symmetry Analysis assesses the association between two medicines in prescription claims data by comparing the sequence of initiation of each medicine during the study period or within a specified period of time ...
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CLINICAL EVALUATION AND POST MARKETING SURVEILLANCE OF MEDICAL DEVICES IN EUROPE
... obtain market authorization for sale of devices in ...the market, companies should be conducting ongoing post-market surveillance to gather data on The real- world use of their devices; ...
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THE POST-MARKET PRIORITY Understanding and Meeting Demand for Effective Post-Market Clinical Follow-Up
... during post-market ...of post-market clinical planning and data as a critical part of the design dossier and/or technical documentation of a ...
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Market surveillance of machinery
... Better coordination of market surveillance and harmonisation of enforcement practices (e.g. a common approach to risk assessment) should be ensured with colleagues in other Member States. It is of the ...
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Post-Trade Surveillance System
... Trade Surveillance System is designed for the Compliance Department of an Investment Banker to detect and monitor irregular or suspicious transaction behavior that may jeopardize the reputation of your ...possible ...
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Post-graduate Course The Management of Market Surveillance and Regulatory Activities in Product Safety Systems
... The Post-graduate Course: “The Management of Market Product Safety Surveillance System” (hereinafter “the Course”) is under the framework of the Consumer Safety and Health Network of the Americas ...
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Surveillance Self-Defense: Privacy in the Post-9/11 Mass Surveillance State
... TITLE: SURVEILLANCE SELF-DEFENSE: PRIVACY IN THE POST-9/11 MASS SURVEILLANCE STATE MAJOR PROFESSOR: Robert Spahr The nature of digital information and the networked world has enabled the greatest ...
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Journalistic freedom and the surveillance of journalists post-Snowden
... intelligence-gathering. Back in 2013 some commentators and journalists posited that he was working for Russian or Chinese intelligence. But that criticism seems to have receded and whether critics are for or against him, ...
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A Proposal for Developing a Market Surveillance Program
... most surveillance departments rely upon the trading-floor brokers to point out unusual activities, as those brokers have a vested interest in maintaining an efficient ...
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NASD Market Surveillance Assessment and Recommendations
... Exchange's surveillance program failed adequately to detect violations by its members of the firm quote rule, trading ahead prohibitions and the limit order display rule from 1998 through ...Exchange's ...
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Market Surveillance and revision of GPS Directive
... the Market surveillance authorities (MSA) lead to risk assessment being carried out differently across Member States and authorities, and result in products being placed on the market in one Member ...
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Decision on Market Surveillance Committee Appointments
... the Market Monitoring Committee of the California Power Exchange ...the market incentives in particular; market rules and structures created and in developing empirical methods for measuring the ...
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Taxis for neoliberalism!? Surveillance and resistance in post-industrial Philadelphia
... their labour and their classification as independent contractors. Traditional acts of resistance were largely ineffective, evidence itself of the embeddedness of neoliberal patterns in the contemporary political economy. ...
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