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.

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

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.

Pharmacovigilance Data or “PV Data” shall mean any Adverse Event (Serious or not), any

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 ▇▇▇▇ with respect to ▇▇▇▇ Pre-Clinical Know-How, ▇▇▇▇ Patent Rights, Pre-Clinical Data, Clinical Data, Pharmacovigilance Data, and Inventions, including ▇▇▇▇’▇ right to the Royalty and ▇▇▇▇’▇ rights connected to such Royalty, shall remain in effect.
If not otherwise expressly provided for and subject to the rights and licenses granted to ▇▇▇▇ and ▇▇▇▇▇▇▇▇ in this Agreement, the rights and obligations of OVAMED with respect to ▇▇▇▇ Pre-Clinical Know-How, ▇▇▇▇ Patent Rights, Pre-Clinical Data, Clinical Data, Inventions, Development costs, and Pharmacovigilance Data shall be, as between OVAMED and ▇▇▇▇, subject to the OVAMED ▇▇▇▇ License and, as between OVAMED and CORONADO, the OVAMED CORONADO Agreements.
In any case ▇▇▇▇ 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.
Security Incidents or Data Breaches, especially notification and subsequent communication, should be handled on an urgent basis, as part of Contractor’s communication and mitigation processes as mutually agreed upon, defined by law, or contained in the Contract, including the Data Handling Controls.
However, notwithstanding the foregoing, the licenses granted to ▇▇▇▇ and/or OVAMED by CORONADO with respect to Pre-Clinical Data, Clinical Data, Pharmacovigilance Data and Inventions shall remain in effect.
However, the licenses granted to ▇▇▇▇ by CORONADO with respect to Pre-Clinical Data, Clinical Data, Pharmacovigilance Data and Inventions shall cease and ▇▇▇▇ shall cease to use the ▇▇▇▇ Pre-Clinical Know-How, Pre-Clinical Data, Clinical Data, Pharmacovigilance Data, or Inventions licensed to it by CORONADO, and shall cease to Develop, use, have made by OVAMED, Commercialize and sell Product, in each case except except as required by law or to the extent required for an orderly transition.
Without further request, ▇▇▇▇ 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.
As soon as reasonably practicable, the Parties shall enter into a separate agreement providing for the exchange and reporting of Pharmacovigilance Data related to the Product according to industry standards and applicable law.

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 (with or without

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.

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.