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.
Sample 1Sample 2
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.
Sample 1Sample 2
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
Sample 1

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); 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
Sample 1
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.
Sample 1

Related to Pharmacovigilance Data

  • Pharmacovigilance Agreement has the meaning set forth in Section 4.3.

  • Research Data means documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Patient Data means any electronic data, information or material about a Patient entered into the Software.

  • Study Data shall have the meaning set forth in Section 8.1.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Diagnostic clinical procedures manual means a collection of written procedures that describes each method (and other instructions and precautions) by which the licensee performs diagnostic clinical procedures; where each diagnostic clinical procedure has been approved by the authorized user and includes the radiopharmaceutical, dosage, and route of administration.

  • Development Data means any and all research data, pharmacology data, chemistry, manufacturing and control data, preclinical data, clinical data and all other documentation (including raw data) compiled, developed or generated with respect to the Compound or Product.

  • 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.

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Protocols means written directions and orders, consistent with the department’s standard of care, that are to be followed by an emergency medical care provider in emergency and nonemergency situations. Protocols must be approved by the service program’s medical director and address the care of both adult and pediatric patients.

  • 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).

  • UNICEF Data means any and all information or data in digital form or processed or held in digital form that

  • Collaborative pharmacy practice agreement means a written and signed

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • CMC means Comprehensive maintenance Contract (labour, spare and preventive maintenance)

  • Research record means any data, document, computer file, computer diskette, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. A research record includes, but is not limited to, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

  • 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.

  • Analytical x-ray system means a group of components utilizing x-rays to determine the elemental composition or to examine the microstructure of materials.

  • Service and support administrator means a person, regardless of title, employed by or under contract with a county board to perform the functions of service and support administration and who holds the appropriate certification in accordance with rule 5123:2-5-02 of the Administrative Code.

  • Regulatory Information Service means a service approved by the London Stock Exchange for the distribution to the public of announcements; and

  • Manufacturing Agreement has the meaning set forth in Section 2.6.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.