Post Marketing Surveillance definition

Post Marketing Surveillance means systematic process to collect and analyse information gained from medical device that have been placed in the market;

Post Marketing Surveillance means a procedure implemented after a drug has been licensed for public use. The procedure is designed to provide information on the actual use of the drug for a given indication and on the occurrence of side effects, adverse reactions, etc. This is a method for identifying adverse drug reactions, especially rare (< 1% incidence) ones.

Post Marketing Surveillance means clinical trial or other investigations usually conducted under a single protocol to gather specific information about an approved medicinal or biological product.

Examples of Post Marketing Surveillance in a sentence

• Post Marketing Surveillance of Fortified Foods in Tanzania Mainland: Large Scale Producers of wheat and Edible oil.

• The dossier should contain the Post Marketing Surveillance/ Vigilance Reporting procedures and Data collected by the manufacturer encompassing the details of the complaints received and corrective and Preventive actions taken for the same.

• The dossier should contain the Post Marketing Surveillance or Vigilance Reporting procedures and Data collected by the manufacturer encompassing the details of the complaints received and corrective and Preventive actions taken for the same.

• Takeda shall conduct and fund all Post Marketing Surveillance on the Products for the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory.

• They confine themselves to challenging the assessments of the facts and evidence produced in the cases.

• All Suspected Unexpected Serious Adverse Reactions (SUSARs) occurring in all post authorization safety studies in Ghana of which the Local Representative or Marketing Authorization Holder is aware and includes the design and conduct of company-sponsored Post Marketing Surveillance (PMS) Studies (i.e Phase IV clinical trials) should be reported within 7 days.

• A new era of regulatory approved and commercially available therapeutics for NMD is upon us and this requires a comprehensive and academic approach to generating real world evidence related to new therapies to inform regulatory decisions and Post Marketing Surveillance.

• Post Marketing Surveillance of Anti-malarial Medicines in Tanzania.

• Phase IV investigations gather extra data about incidental effects and security, long haul dangers and advantages, or potentially the way that well the medication works when utilized broadly.Phase IV trial is also called Post Marketing Surveillance, Phase IV preliminaries include the safety surveillance (pharmacovigilance) and continuous specialized backing of a medication after it gets consent to be sold.

• Three-Year Clinical Outcomes of Everolimus-Eluting Stents from the Post Marketing Surveillance Study of CoCr-EES (XIENCE V/PROMUS) in Japan.

More Definitions of Post Marketing Surveillance

Post Marketing Surveillance means the set of activities carried out by the Authority to monitor quality of medicines and allied substances when they are in distribution, warehouses, pharmacies, clinics, medicine stores, and hospitals;

Post Marketing Surveillance means all post-marketing safety surveillance in the Initial Territory with respect to the Product that is required by a Regulatory Authority in the Initial Territory or any Additional Territory in which the Products are being Developed or Commercialized.

Post Marketing Surveillance means surveillance activities that occur following market approval of a medical product including maintenance of product authorisation and/or registration of variations or renewals; regular inspection of manufacturers, wholesalers, distributors and retailers; quality control testing; pharmacovigilance; promotion control; public reporting of poor quality products; handling of market complaints; and removal and disposal of non-compliant products;

Post Marketing Surveillance or "PMS" shall have the meaning ascribed to it in Section 7.6 of this Agreement.