Pharmacovigilance Data definition

Pharmacovigilance Data or “PV Data” shall mean any Adverse Event (Serious or not), any incident, or any of the following special situations (with or without Adverse Events): any report of misuse; any medication error; any off-label use (intentional use outside the labelled indication); any overdose (intentional or not); any drug abuse, dependence, addiction, (withdrawal syndrome); any lack of efficacy; any drug exposure during pregnancy or child exposure during breastfeeding or conception (whether from the male or female); any occupational exposure (unintentional exposure during work); accidental exposure; unexpected therapeutic benefit; any suspected transmission of infectious agents; and/or suspected drug interactions involving active ingredients or their metabolites. Where a PTC arises in conjunction with an AE, such complaints are subject to the reporting obligations applicable to PV Data in Article-2 below.
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Pharmacovigilance Data means information generated by or on behalf of a Party in connection with its pharmacovigilance duties related to the Product including but not limited to information generated in connection with adverse reaction reporting, development safety update reports, periodic safety update reports and post-authorisation safety studies.
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Pharmacovigilance Data or “PV Data” shall mean any Adverse Event (Serious or not), any
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Examples of Pharmacovigilance Data in a sentence

  • Within ninety (90) days after the Effective Date, the parties shall enter into a mutually agreeable Pharmacovigilance Data Exchange Agreement with respect to the Recro Products.

  • To ensure that all relevant safety information for Dexmedetomidine Products is exchanged between the Parties, the Parties will prepare a Pharmacovigilance Data Exchange Agreement governing the collection, reporting, and exchange of information concerning adverse drug reactions and other relevant drug safety related matters with respect to Recro Products during the Development sufficient to permit each party to comply with its legal and regulatory obligations.

  • Notwithstanding the foregoing, the licenses granted to CORONADO by XXXX with respect to XXXX Pre-Clinical Know-How, XXXX Patent Rights, Pre-Clinical Data, Clinical Data, Pharmacovigilance Data, and Inventions, including XXXX’x right to the Royalty and XXXX’x rights connected to such Royalty, shall remain in effect.

  • In any case CORONADO is not allowed to retain any of the XXXX Pre-Clinical Know-How, Pre-Clinical Data, Clinical Data, Pharmacovigilance Data, or Inventions licensed to it by XXXX, and any of XXXX’x Confidential Information in any form.

  • Without further request, XXXX shall promptly send or return to CORONADO all documents, copies of documents and electronically memorised data referencing Pre-Clinical Data, Clinical Data, Pharmacovigilance Data, and Inventions licensed to it by CORONADO, and CORONADO’s Confidential Information.

  • If XXXX effectively terminates this Agreement for non-payment or material breach by CORONADO in accordance with Article 20.2(a) or 20.2(b), the licenses granted to XXXX and/or OVAMED by CORONADO with respect to Pre-Clinical Data, Clinical Data, Pharmacovigilance Data and Inventions shall remain in effect.

  • Any and all adverse events shall be handled and reported consistent with the applicable provisions of the Pharmacovigilance Data Exchange Agreement entered into by and among ImClone, BMS and Merck as of November 1, 2006, as amended from time to time.

  • To ensure that all relevant safety information for Fadolmidine Products is exchanged between the Parties, the Parties will prepare a Pharmacovigilance Data Exchange Agreement governing the collection, reporting, and exchange of information concerning adverse drug reactions and other relevant drug safety related matters with respect to Recro Products during the Development sufficient to permit each party to comply with its legal and regulatory obligations.

  • In any case XXXX is not allowed to retain any of the Pre-Clinical Data, Clinical Data, Pharmacovigilance Data, or Inventions licensed to it by CORONADO, and any of CORONADO’s Confidential Information in any form.

  • Without further request, CORONADO shall promptly send or return all documents, copies of documents and electronically memorised data referencing the XXXX Pre-Clinical Know-How, Pre-Clinical Data, Clinical Data, Pharmacovigilance Data, and Inventions licensed to it by XXXX, and XXXX’x Confidential Information.


More Definitions of Pharmacovigilance Data

Pharmacovigilance Data or “PV Data” shall mean any Adverse Event (Serious or not), any Incident (Serious or not), or any of the following special situations (w ith or without A dverse Events): any report of misuse; any medication error; any off-label use (intentional use outside the labelled indication); any overdose (intentional or not); any drug abuse, dependence, addiction, (withdrawal syndrome); any lack of efficacy; any drug exposure during pregnancy or child exposure during breastfeeding or conception (whether from the male or female); any occupational exposure (unintentional exposure during work); accidental exposure; unexpected therapeutic benefit; any suspected transmission of infectious agents; and / or suspected drug interactions involving active ingredients or their metabolites
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Pharmacovigilance Data or "PV Data" shall mean any Adverse Event (Serious or not); or any of the following special situations (with or without Adverse Events): any report of misuse; any medication error; any off-label use (intentional use outside the labelled indication); any overdose (intentional or not); any drug abuse/dependence/addiction (withdrawal syndrome); any lack of efficacy; any drug exposure during pregnancy or child exposure during breastfeeding or conception (whether from the male or female); any occupational exposure (unintentional exposure during work); accidental exposure; unexpected therapeutic benefit; any suspected transmission of infectious agents; and / or suspected drug interactions involving active ingredients or their metabolites.
Sample 1
Pharmacovigilance Data or “PV Data” shall mean any Adverse Event (Serious or not), any Incident (Serious or not), or any of the following special situations (with or without Adverse Events): any report of misuse; any medication error; any off-label use (intentional use outside the labelled indication); any overdose (intentional or not); any drug abuse, dependence, addiction, (withdrawal syndrome); any lack of efficacy; any drug exposure during pregnancy or child exposure during breastfeeding or conception (whether from the male or female); any occupational exposure (unintentional exposure during work); accidental exposure; unexpected therapeutic benefit; any suspected transmission of infectious agents; and / or suspected drug interactions involving active ingredients or their metabolites “Product(s)” shall mean all the products owned and / or manufactured and / or commercialized by the CLIENT or any of its Affiliates, including medicinal products, devices, cosmetics and food supplements “Product complaint”, “Product Technical Complaint” or “PTC” refers to any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, efficacy or performance of a product, device, its packaging, or any written leaflet or other information provided with such product or device, after it is released for distribution. Where a PTC is also associated with PV Data this should be notified to CLIENT PV in accordance with the procedure set out in Article [XX] below
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Pharmacovigilance Data means i) all serious and non-serious safety reports from unsolicited notifications collected worldwide either by sanofi-aventis or Licensor and its Affiliates; ii) Adverse Event including those related to quality defect, experience during pregnancy and lactation, even uneventful, drug exposure via parent, lack of efficacy, even uneventful, overdose (symptomatic or not), interaction (symptomatic or not), misuse and medication error (symptomatic or not), drug abuse, unintended beneficial effects and iii) Serious Adverse Events from solicited reports.
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Related to Pharmacovigilance Data

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Regulatory Services Agreement means the agreement between BSEF and the Regulatory Services Provider whereby the Regulatory Services Provider provides market surveillance and trade practice surveillance functions as well as other compliance related services to the SEF operated by BSEF.