Good Pharmacovigilance Practices definition

Good Pharmacovigilance Practices or “GVP” means the then-current good pharmacovigilance practice standards, practices, and procedures promulgated or endorsed by any applicable Regulatory Authority as set forth in the guidelines imposed by such Regulatory Authority, as may be updated from time to time.
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Good Pharmacovigilance Practices or “GPV” means all applicable good pharmacovigilance practices promulgated and published by FDA, EMA or any other Regulatory Authorities having jurisdiction over the Development, Manufacture or Commercialization of INTASYL PH-762 , DP TIL, or the Product, as applicable, pursuant to its regulations, guidelines or otherwise, including as applicable, major pharmacovigilance process and product and/or population specific considerations as defined in (a) European Commission Regulation code relating to medicinal products for human use, Directives 2010/84/EU and 2012/26/EU respectively, as well as by the Commission Implementing Regulation (EU) No 520/2012 on the Performance of Pharmacovigilance Activities Provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC, Title IX of the Directive, Article 108a (a) of Directive 2001/83/EC, and principles detailed in the ICH guidelines for pharmacovigilance as well as (b) principles detailed in the United States 21 CFR and Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiological Assessment.
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Good Pharmacovigilance Practices means a set of guidelines for the conduct of pharmacovigilance in the EU, drawn up based on Article 108a of Directive 2001/83/EC, by the European Medicines Agency in cooperation with competent authorities in Member States and interested parties, and applying to marketing authorization holders in the EU or the Territory.
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Examples of Good Pharmacovigilance Practices in a sentence

  • All newly acquired safety information will continue to be actively monitored in accordance with Good Pharmacovigilance Practices, including regular review and evaluation of cumulative data.

  • MEDIALDEAExecutive SecretaryANNEX “C” FOI Receiving Officers of ISCOF Name of OfficeLocation of FOI Receiving Office Contact DetailsAssigned FOI Receiving Officer ISCOF Main CampusOffice of Chief Administrative OfficerAdministration Building09278504299iscofmain@gmail.comMrs.

  • EMA, Guideline on Good Pharmacovigilance Practices, Module V –Risk Management Systems.

  • Guidance for Industry – Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.

  • When reporting results of this study, the appropriate STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist (von Elm et al., 2008) will be followed.In line with the EMA Guideline on Good Pharmacovigilance Practices (GVP).

  • The study will be registered in the ENCePP electronic register of post-authorisation studies (EU PAS register) (ENCePP, 2010) as detailed in the module VIII of the EU Guideline on Good Pharmacovigilance Practices (GVP) (EMA, 2012a).

  • Gilead will ensure that the report meets the standards set out in the Guideline on Good Pharmacovigilance Practices (GVP) Module VIII.

  • European Medicines Agency (EMA) - EMA/873138/2011 Guideline on Good Pharmacovigilance Practices.

  • Guidance for Industry: Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment.

  • EMA Guidelines on Good Pharmacovigilance Practices (GVP)Module V – Risk management systems (Rev.


More Definitions of Good Pharmacovigilance Practices

Good Pharmacovigilance Practices or “cGPvP” means the then-current good pharmacovigilance practices recommended by the FDA, EMA (including Volume 9A of The Rules Governing Medicinal Products in the European Union — Guidelines on Pharmacovigilance for Medicinal Products for Human Use), or other Regulatory Authority applicable to the Licensed Territory, as they may be updated from time to time, including applicable guidelines under the ICH.
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Good Pharmacovigilance Practices or “GVP” means, in addition to the provisions under the Pharmacovigilance
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Good Pharmacovigilance Practices or “GVP” means, in addition to the provisions under the Pharmacovigilance Agreement, all applicable good pharmacovigilance practices promulgated and published by the FDA, EMA or any other applicable Regulatory Authority including, as applicable, major pharmacovigilance process and product and/or population specific considerations as defined in (a) European Commission Regulation code relating to medicinal products for human use, Directives 2010/84/EU and 2012/26/EU, as well as by the Commission Implementing Regulation (EU) No 520/2012 on the Performance of Pharmacovigilance Activities provided for in Regulation (EC) No 726/2004 and Directive 2001/83/EC, Title IX and Article 108a(a) and principles detailed in the ICH guidelines for pharmacovigilance as well as (b) principles detailed in the United States 21 CFR and Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiological Assessment.
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Related to Good Pharmacovigilance Practices

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

  • 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.

  • 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.

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

  • 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

  • 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.

  • 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 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.

  • 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.

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

  • 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.

  • Best management practices (BMP) means schedules of activities, prohibitions of practices, maintenance procedures, and other management practices to prevent or reduce the pollution of waters of the United States. BMPs include treatment requirements, operation procedures, and practices to control plant site runoff, spillage or leaks, sludge or waste disposal, or drainage from raw material storage.

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

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

  • Good Industry Practices means the practices that would be adopted by, and the exercise of that degree of care, skill, diligence, prudence and foresight that reasonably would be expected from, a competent contractor in the international oil and gas industry experienced in performing work similar in nature, size, scope and complexity to the Work and under conditions comparable to those applicable to the Work, where such work is subject to, and such contractor is seeking to comply with, the standards and codes specified in the Contract or (to the extent that they are not so specified) such national or international standards and codes as are most applicable in the circumstances, and the applicable Law.

  • 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.

  • cGLP means the current good laboratory practice regulations promulgated by the FDA, published at 21 C.F.R. § 58, and all applicable FDA rules, regulations, orders and guidances and equivalent or comparable non-United States regulations, rules, orders, guidances and standards in the Territory, as applicable, as such current laboratory practices, rules, regulations, orders, guidances and standards may be amended from time to time.

  • 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.

  • Quality Management System means a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives are achieved;

  • Proper practices means those set out in The Practitioners’ Guide

  • Best Practices means a term that is often used inter-changeably with “evidence-based 24 practice” and is best defined as an “umbrella” term for three levels of practice, measured in relation to 25 recovery-consistent mental health practices where the recovery process is supported with scientific 26 intervention that best meets the needs of the Client at this time. 27 a. EBP means Evidence-Based Practices and refers to the interventions utilized for which 28 there is consistent scientific evidence showing they improved Client outcomes and meets the following 29 criteria: it has been replicated in more than one geographic or practice setting with consistent results; it

  • Employment Practices means any wrongful or unfair dismissal, denial of natural justice, defamation, misleading representation or advertising, unfair contracts, harassment or discrimination (sexual or otherwise) in respect of employment by the Insured.

  • collusive practices means a scheme or arrangement between two or more Bidders, with or without the knowledge of the Procuring Entity, designed to establish bid prices at artificial, non-competitive levels.

  • Best management practice (BMP) means a structural device or nonstructural practice designed to temporarily store or treat stormwater runoff in order to mitigate flooding, reduce pollution, and provide other amenities.

  • 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.