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 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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Examples of Pharmacovigilance Data in a sentence

  • Let K Q denote the minimal extension of k over which all endomorphisms of AQ are defined,and let Ω/k denote a minimal subextension of K/k over which there exists an isogenyψ : A −∼→ E1 × E2,defined over Ω onto a product of two elliptic curves E1/Ω and E2/Ω.

  • Domain knowledge guided deep learning with electronic health records.

  • However, notwithstanding the foregoing, 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.

  • 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.

  • 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.

  • However, the licenses granted to XXXX by CORONADO with respect to Pre-Clinical Data, Clinical Data, Pharmacovigilance Data and Inventions shall cease and XXXX shall cease to use the XXXX 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.

  • 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.

  • As every year, GMP trainings, Risk Management, Pharmacovigilance, Data Protection and Competition are a priority for the employees of Biofarm SA, and they are carried out according to the annual plans.

  • 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.

  • If XXXXXXXX terminates this Agreement for non-payment or material breach by XXXX in accordance with Article 20.2(a) or 20.2(b), 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, shall remain in effect.


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

  • Pharmacovigilance Agreement has the meaning set forth in Section 5.1.

  • 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.

  • Development Data means all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other information, in each case, that is generated by or resulting from or in connection with the conduct of Development of Products.

  • 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

  • Manufacturing and Supply Agreement means the Manufacturing and Supply Agreement by and between Biogen and Bioverativ, in the form attached hereto as Exhibit C.

  • Collaborative pharmacy practice agreement means a written and signed

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

  • 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.

  • Regulatory Information Service means a regulatory information service as defined in the Takeover Rules.

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

  • 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.

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.