Good Pharmacovigilance Practice definition

Good Pharmacovigilance Practice means the guideline on good pharmacovigilance practice published by the European Medicines Agency under Regulation (EU) 1235/2010, as amended by Regulation (EU) 1027/2012, and Directive 2010/84/EU, as amended by Directive 2012/26/EU, and the principles laid down in Commission Implementing Regulation (EU) 520/2012; [***] means as is defined in Clause 12.5(a); Improvement(s) means any analogue, modification, prodrug, salt, polymorph, metabolite, isomer or synthetic intermediate of a Licensed Compound (i) discovered solely by Nuvectis, its Affiliates or Sub-Licensees during the Term; or (ii) that was discovered solely by the University or jointly by Nuvectis and the University pursuant to the Development Collaboration Agreement. Improvements licensed under this Agreement as part of the Collaboration IP shall be detailed in Schedule 5 as updated from time to time under the heading Improvement Compound Know-How and/or Improvement Compound Patent as the case may be; Improvement Compound IP means Improvement Compound Know-How and Improvement Compound Patent;
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Good Pharmacovigilance Practice means the Guidelines on Pharmacovigilance for Medicinal Products for Human Use published by the European Commission under Article 108a of the 2001 Directive;
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Good Pharmacovigilance Practice means the applicable principles and guidelines for good pharmacovigilance practice for drugs and medicinal products, as such principles and guidelines are amended, implemented and supplemented from time-to-time, including without limitation those set out in the European Medicines Agency’s GVP modules I to XVI.”
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Examples of Good Pharmacovigilance Practice in a sentence

  • By taking five-year windows, we account for yearly fluctuations and the fact that a patent application and the knowledge it represents can have a long-lasting impact on the firm’s preclinical R&D knowledge base.

  • Member States shall ensure the effective functioning of the national pharmacovigilance system in accordance with the Good Pharmacovigilance Practice approved by the Commission and the legislation of the Member States.

  • The competent authorities of the Member States ensure the control of fulfillment of pharmacovigilance obligations by the holders of registration certificates of medicinal products that are in circulation in the territories of the Member States in accordance with the Good Pharmacovigilance Practice and the legislation of the Member States.

  • The research team will apply for the ENCePP Study Seal (ENCePP, 2016c).The study is a postauthorisation safety study (PASS) and will comply with the definition of the non-interventional (observational) study provided in the 2016 Revision 2 of the Guideline on Good Pharmacovigilance Practice (GVP): Module VIII – Post-Authorisation Safety Studies (EMA, 2016).

  • Under EU legislation Bayer and its contracted partners are obliged to fulfil certain Pharmacovigilance responsibilities stated in the Good Pharmacovigilance Practice (GVP) and relevant guidelines.

  • In accordance with the European Medicines Agency’s Guideline on Good Pharmacovigilance Practice (GVP), Module VIII: Post-Authorization Safety Studies, this non-interventional PASS will be publically disclosed in the EU Post-Authorisation Study (PAS) register, which is currently the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance’s (ENCePP) Electronic Register of Studies (http://www.encepp.eu/encepp/studiesDatabase.jsp).

  • Both management/advanced groups felt that the lack of a specific reference to “capacity” was an important omission within the Code.

  • The study will be conducted in accordance with legal and regulatory requirements, as well as with scientific purpose, value and rigor and follow generally accepted research practicesdescribed in Guidelines for Good Pharmacoepidemiology Practices (GPP) issued by the International Society for Pharmacoepidemiology (ISPE), European Medicines Agency (EMA) Guideline for Good Pharmacovigilance Practice (GVP).

  • Specifically, Module XVI of European Good Pharmacovigilance Practice, ‘selection of tools and effectiveness indicators’, endorses the use of “scientifically rigorous survey methods” to assess the awareness of the target audience and the level of knowledge achieved by educational interventions and/or information provision {Agency 2017}.

  • For this reason, they must comply with all applicable procedures designed to ensure patient safety (Good Laboratory Practice, GLP, Good Pharmacovigilance Practice, GPvP, Good Distribution Practice, GDP) and to immediately report to the company any adverse reactions or complaints regarding products distributed by FARMASYN or any falsified (counterfeit) medicines.


More Definitions of Good Pharmacovigilance Practice

Good Pharmacovigilance Practice means the Guidelines on Pharmacovigilance for Medicinal Products for Human Use published by the European Commission pursuant to Article 106 of the 2001 Directive;
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Good Pharmacovigilance Practice or “GPP” the then current “good pharmacovigilance practice as such term is defined from time to time by the FDA, EMA or other Regulatory Authority of competent jurisdiction pursuant to its regulations, guidelines or otherwise, as applicable;
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Good Pharmacovigilance Practice means the then current standards, practices and procedures for pharmacovigilance promulgated or endorsed by any applicable Governmental Entity, including those of the United States, as set forth in the FDCA, 21 C.F.R. § 314.80, or other comparable Law of any comparable foreign Governmental Entity; “Governmental Entity”, (i) any Relevant Authority, (ii) any company, business, enterprise, or other entity owned, in whole or in part, or controlled by any Relevant Authority, or (iii) any political party;
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Good Pharmacovigilance Practice means the then current standards, practices and procedures for pharmacovigilance promulgated or endorsed by any applicable Governmental Entity, including those of the United States, as set forth in the FDCA, 21 C.F.R. § 314.80, or other comparable Law of any comparable foreign Governmental Entity;
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Related to Good Pharmacovigilance Practice

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

  • Collaborative pharmacy practice means a practice of pharmacy whereby one or

  • Collaborative practice means that a physician may delegate aspects of drug therapy management for the physician’s patients to an authorized pharmacist through a community practice protocol. “Collaborative practice” also means that a P&T committee may authorize hospital pharmacists to perform drug therapy management for inpatients and hospital clinic patients through a hospital practice protocol.

  • Good Clinical Practices means the FDA’s standards for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials contained in 21 C.F.R. Part 50, 54, 56, 312, 314, 320, 812, and 814 and (ii) “Good Laboratory Practices” means the FDA’s standards for conducting non-clinical laboratory studies contained in 21 C.F.R. Part 58.

  • Good Manufacturing Practices means current good manufacturing practices, as set forth in 21 C.F.R. Parts 210 and 211.

  • Collaborative pharmacy practice agreement means a written and signed

  • Good Laboratory Practice or “GLP” means the applicable then-current standards for laboratory activities for pharmaceuticals (including biologicals) or vaccines, as applicable, as set forth in the Act and any regulations or guidance documents promulgated thereunder, as amended from time to time, together with any similar standards of good laboratory practice as are required by any Regulatory Authority having jurisdiction over the applicable activity.

  • Good Laboratory Practices or “GLP” means the then-current Good Laboratory Practice (or similar standards) for the performance of laboratory activities for pharmaceutical products as are required by applicable Regulatory Authorities or Applicable Law. In the United States, Good Laboratory Practices are established through FDA regulations (including 21 C.F.R. Part 58), FDA guidance, FDA current review and inspection standards and current industry standards.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • Good Clinical Practice or “GCP” means the then current standards for clinical trials for pharmaceuticals, as set forth in the ICH guidelines and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good clinical practice as are required by the European Union and other organizations and governmental agencies in countries in which a Licensed Product is intended to be sold to the extent such standards are not less stringent than the ICH guidelines.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Good Manufacturing Practice or “GMP” means the current good manufacturing practices applicable from time to time to the manufacturing of a Product or any intermediate thereof pursuant to Applicable Law.

  • 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;

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

  • 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.

  • Group practice means a group of two or more health care providers legally organized as a partnership, professional corporation, or similar association:

  • cGMPs means, as applicable, current good manufacturing practices as described in:

  • Clinical nurse specialist means a registered nurse with relevant post-basic qualifications and 12 months’ experience working in the clinical area of his/her specified post-basic qualification, or a minimum of four years’ post-basic registration experience, including three years’ experience in the relevant specialist field and who satisfies the local criteria.

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

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Collaborative practice agreement means a written agreement

  • GCP means the Good Clinical Practices officially published by EMA, FDA and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that may be in effect from time to time and are applicable to the testing of the Compounds.

  • Licensed mental health professional or "LMHP" means a physician, licensed clinical psychologist, licensed professional counselor, licensed clinical social worker, licensed substance abuse treatment practitioner, licensed marriage and family therapist, certified psychiatric clinical nurse specialist, licensed behavior analyst, or licensed psychiatric/mental health nurse practitioner.

  • ERCOT Protocols means the document adopted by ERCOT, including any attachments or exhibits referenced in that document, as amended from time to time, that contains the scheduling, operating, planning, reliability, and Settlement (including Customer registration) policies, rules, guidelines, procedures, standards, and criteria of ERCOT. For the purposes of determining responsibilities and rights at a given time, the ERCOT Protocols, as amended in accordance with the change procedure(s) described in the ERCOT Protocols, in effect at the time of the performance or non-performance of an action, shall govern with respect to that action.

  • Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer;