A Systematic Literature Review of the Determinants of Signal Detection In Post-Marketing Surveillance Systems

Drug Safety ◽  
2008 ◽  
Vol 31 (10) ◽  
pp. 885-960 ◽  
2021 ◽  
pp. 135-147
Author(s):  
Nour Ahmed Ghoniem ◽  
Samiha Hesham ◽  
Sandra Fares ◽  
Mariam Hesham ◽  
Lobna Shaheen ◽  
...  

2020 ◽  
Vol 181 ◽  
pp. 104560 ◽  
Author(s):  
Marion Bordier ◽  
Theethawat Uea-Anuwong ◽  
Aurélie Binot ◽  
Pascal Hendrikx ◽  
Flavie L. Goutard

Author(s):  
S Sridhar ◽  
V Balamuralidhara ◽  
V Balamuralidara

The medical device vigilance system was set up to minimize risks to the safety of patients, users and others by detecting the possible adverse reactions in patients, the medical device safety issues are identified and reported manufacture or health professional through identification and reporting of issues by members of the public or through information sharing with other competent authorities. Medical device reporting is important from the processing and reporting of single adverse incidents through to the removal of products from the market as part of a Field Safety Corrective Action, Manufacturers are obliged to maintain robust medical device vigilance and post-marketing surveillance systems for the maintenance of the marketing authorization in the country were the product is marketed.


2021 ◽  
Vol 12 (4) ◽  
pp. 8
Author(s):  
Manal Mohammed Younus ◽  
Ali Azeez Al-Jumaili

The need for the safety monitoring of the COVID-19 vaccine is unprecedented. It is an ongoing process starting from different phases of clinical trials and continued to post-marketing to tackle the emergency used authorized COVID-19 vaccines across the world. Rapid detection, exchange, prioritization, and assessment of safety signals based on available real-world data, surveillance of Adverse events following immunization (AEFI), and adverse event of special interest (AESI) by studying the observed/expected cases. Enhanced collaboration, and availability of resources, tools, and methods will add to the lessons learned from previous experiences.


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