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;
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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.
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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.
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Examples of Post Marketing Surveillance in a sentence

  • The recommended content of the PSUR should have data as per Schedule Y of Drugs and Cosmetics Act, 1940 and Rules 1945, Section (4) Post-Marketing Surveillance and ICH-E2C (R2) guideline.


More Definitions of Post Marketing Surveillance

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.
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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;
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Post Marketing Surveillance or "PMS" shall have the meaning ascribed to it in Section 7.6 of this Agreement.
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Post Marketing Surveillance means surveillance activities that occur following market approval of a regulated product including maintenance of product authorisation and/or registration of variations or renewals; regular inspection of manufacturers, wholesalers, distributors and retailers; quality control testing; public reporting of poor quality products; handling of market complaints; and removal and disposal of non-compliant products
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Related to Post Marketing Surveillance

  • market surveillance means the activities carried out and measures taken by public authorities to ensure that products comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection;

  • medical surveillance means a planned programme or periodic examination (which may include clinical examinations, biological monitoring or medical tests) of employees by an occupational health practitioner or, in prescribed cases, by an occupational medicine practitioner;

  • Surveillance means monitoring and observation of the disposal site for purposes of visual detection of need for maintenance, custodial care, evidence of intrusion, and compliance with other license and regulatory requirements.

  • market surveillance authority means an authority of a Member State responsible for carrying out market surveillance on its territory;

  • Direct Marketing ’ means to approach a data subject, either in person or by mail or electronic communication, for the direct or indirect purpose of—

  • Marketing means a direct or indirect offering or placement at the initiative of the AIFM or on behalf of the AIFM of units or shares of an AIF it manages to or with investors domiciled or with a registered office in the Union;

  • Department Chair means the chair of a department or the director of a centre or program.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Metropolitan planning organization means the same as that term is defined in Section 72-1-208.5.

  • Professional development means training programs for

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Police Department means the Police Department of the City and County of San Francisco.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • Street Trading means the selling or exposing or the offering for sale of any article (including a living thing) or the supplying or offering to supply any service in a street for gain or reward.

  • Supplemental Marketing Material means any Issuer Free Writing Communication other than any Issuer Free Writing Communication specified in Schedule B hereto. Supplemental Marketing Materials include, but are not limited to, any Issuer Free Writing Communication listed on Schedule C hereto.

  • SBD means Standard Bidding Documents.

  • PIR means Problem Identification Report.

  • Regulatory Floodway means the channel of a river or other watercourse and the adjacent land areas that must be reserved in order to discharge the base flood without cumulatively increasing the water surface elevation more than a designated height.

  • Commercial Services means any waste management service, relating or connected to accumulating, collecting, managing, recycling, sorting, storing, treating, transporting, disposing, buying or selling of waste or any other manner of handling waste excluding services rendered by the municipality;

  • Department sample means liquor that is placed in the possession of the

  • Health planning region means a contiguous geographical area of the Commonwealth with a

  • Monitoring Indicator means a measure of HSP performance that may be monitored against provincial results or provincial targets, but for which no Performance Target is set;

  • PJM Markets means the PJM Interchange Energy and capacity markets, including the RPM auctions, together with all bilateral or other wholesale electric power and energy transactions, capacity transactions, ancillary services transactions (including black start service), transmission transactions and any other market operated under the PJM Tariff or Operating Agreement within the PJM Region, wherein Market Participants may incur Obligations to PJMSettlement. PJM Market Rules:

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Telemarketing means any plan, program, or campaign which is conducted to induce the purchase of goods or services by use of one or more telephones, and which involves a telephone call, whether or not covered by the Telemarketing Sales Rule.

  • Local Marketing Agreement means, a local marketing agreement, time brokerage agreement or similar arrangement pursuant to which a Person, subject to customary licensee preemption rights and other limitations, obtains the right to exhibit programming and sell advertising time constituting 15% or more of the air time per week of a television broadcast station licensed to another Person.