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Post-market surveillance of medical devices: A review
Technology and Health Care, 2022BACKGROUND: Medical devices (MDs) represent the backbone of the modern healthcare system. Considering their importance in daily medical practice, the process of manufacturing, marketing and usage has to be regulated at all levels. Harmonized evidence-based conformity assessment of MDs during PMS relying on traceability of medical device measurements ...
Almir, Badnjević +3 more
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Optimization of the post-marketing surveillance procedure
Annales de biologie clinique, 2017Ceux qui utilisent les dispositifs medicaux pendant leurs activites quotidiennes ne pensent pas forcement aux processus reglementaires qui precedent et suivent la mise en vente de ces dispositifs. Ces processus sont cependant essentiels a la securite des patients. Il est donc rassurant que les organismes regulateurs deviennent de plus en plus exigeants
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Post-marketing surveillance of oral contraceptives*
Human Reproduction, 1986Problems arise in the post-market surveillance of the possible long-term effects of oral contraceptives. These drugs are taken by very large numbers of people, in various doses, types and duration. One aspect is considered in this paper, the effects on pregnancy of these drugs taken before conception.
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Post-Marketing Surveillance of the Safety of Levofloxacin in Japan
Chemotherapy, 2007<i>Background:</i> Central nervous system reactions to new quinolones, such as convulsions due to interaction with nonsteroidal anti-inflammatory drugs (NSAIDS), have attracted increased attention in Japan. <i>Methods:</i> The safety of levofloxacin (LVX) was investigated in Japan by post-marketing surveillance and reviewing ...
Hiroki, Yamaguchi +6 more
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Post-marketing drug surveillance
1981It is regrettable that the term ‘Post-marketing Surveillance’ (PMS) has become synonymous in many minds with certain types of prescription-based monitoring, proposed during the last 5 years1–5, to the exclusion of other methods that have been in effective use for many years.
W. H. W. Inman, C. T. Dollery
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Post-marketing surveillance of quinolones 1988–1990
European Journal of Clinical Microbiology and Infectious Diseases, 1991It has been much easier to obtain original data on adverse drug reactions (ADR) of quinolones from the pharmaceutical industry than it was two years ago. This is to be welcomed and, as anticipated, the new data continue to suggest that the new 4-quinolones have an ADR profile which is very similar to that of other antimicrobials.
P G, Davey, T, McDonald, G, Lindsay
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Post-Marketing Surveillance of Psychotropic Drugs
1989At the end of a highly sophisticated scientific programme, the author has the honour as well as the difficulty to consider more generally the field of post-marketing surveillance of psychotropic drugs. Although post-marketing surveillance has gained considerable attention in recent years, little has been published about post-marketing surveillance of ...
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[Post-marketing surveillance studies].
Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz, 2005Approval of a drug on the market is typically considered as the successful endpoint of a long development phase. This often leads to reduced interest in further research for the indication approved, while in contrast the patient's as well as physician's interest in further research increases. This paper discusses the main areas of effectiveness, safety
I, Pigeot, J, Windeler
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post-marketing surveillance (PMS)
2009syn. drug monitoring, pharmacoepidemiology involves the collection of clinical data on marketed medicines, primarily on drug safety (incidence of esp. rare side effects, new hazards, specific risk factors, risk/benefit analysis) but also on unexpected benefits, and their scientific evaluation or cost/benefit aspects, and to evaluate if drugs are ...
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