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Postmarketing surveillance. Postmarketing surveillance (PMS), also known as post market surveillance, is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market and is an important part of the science of pharmacovigilance. Since drugs and medical devices are approved on the basis ...
Electronic data capture. An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. [1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and ...
The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). [1] VAERS is a postmarketing surveillance program, collecting information about adverse events (possible harmful side effects) that ...
Regulation (EU) 2017/745 is a regulation of the European Union on the clinical investigation and sale of medical devices for human use. It repeals Directive 93/42/EEC (MDD), which concerns medical devices, and Directive 90/385/EEC, which concerns active implantable medical devices, on 26 May 2021. The regulation was published on 5 April 2017 ...
Corporate surveillance describes the practice of businesses monitoring and extracting information from their users, clients, or staff. [1] This information may consist of online browsing history, email correspondence, phone calls, location data, and other private details. Acts of corporate surveillance frequently look to boost results, detect ...
Disease registry. Disease or patient registries are collections of secondary data related to patients with a specific diagnosis, condition, or procedure, and they play an important role in post marketing surveillance of pharmaceuticals. [1] Registries are different from indexes in that they contain more extensive data.
Surveillance capitalism. Surveillance capitalism is a concept in political economics which denotes the widespread collection and commodification of personal data by corporations. This phenomenon is distinct from government surveillance, although the two can be mutually reinforcing. The concept of surveillance capitalism, as described by ...
The vast majority of computer surveillance involves the monitoring of data and traffic on the Internet. [9] In the United States for example, under the Communications Assistance For Law Enforcement Act, all phone calls and broadband Internet traffic (emails, web traffic, instant messaging, etc.) are required to be available for unimpeded real-time monitoring by federal law enforcement agencies.