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- Qualified_Person_Responsible_For_Pharmacovigilance abstract "In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU. This function was established in 2004 by article 23 of regulation (EC) No 726/2004. The article establishes that the holder of a marketing authorization for a drug for human use must have a QPPV.\"The holder of an authorisation for a medicinal product for human use granted in accordance with the provisions of this Regulation shall have permanently and continuously at his disposal an appropriately qualified person responsible for pharmacovigilance.\"The QPPV must reside in the European Union. Per Article 23, the QPPV is responsible for: Establishing and maintaining a pharmacovigilance system Preparing pharmacovigilance reports as defined by regulations Answering requests from Health Authorities Providing Health Authorities with any other information relevant to product safetyVolume 9A provides further guidance regarding these responsibilities of the QPPV (Part I, Chapter 1.2, Section 1.2.1: The Role and Responsibilities of the Qualified Person Responsible for Pharmacovigilance). Per Volume 9A, the QPPV is responsible for \"overall pharmacovigilance for all medicinal products for which the company holds marketing authorisations within the EU\", and specifically for: Establishing and maintaining/managing the pharmaceutical company's pharmacovigilance system Having an overview of the safety profiles and any emerging safety concerns for the company's drugs Acting as a single contact point for the Health Authorities on a 24-hour basis".
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageExternalLink reg_2004_726_en.pdf.
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageExternalLink vol9a_09-2008.pdf.
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageID "25212610".
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageLength "2725".
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageOutDegree "5".
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageRevisionID "538350969".
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageWikiLink Category:Clinical_research_ethics.
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageWikiLink Category:Pharmaceuticals_policy.
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageWikiLink EudraLex.
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageWikiLink European_Medicines_Agency.
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageWikiLink Pharmacovigilance.
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageUsesTemplate Template:Mergeto.
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageUsesTemplate Template:Multiple_issues.
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageUsesTemplate Template:Notability.
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageUsesTemplate Template:Pharma-stub.
- Qualified_Person_Responsible_For_Pharmacovigilance wikiPageUsesTemplate Template:Unreferenced.
- Qualified_Person_Responsible_For_Pharmacovigilance subject Category:Clinical_research_ethics.
- Qualified_Person_Responsible_For_Pharmacovigilance subject Category:Pharmaceuticals_policy.
- Qualified_Person_Responsible_For_Pharmacovigilance hypernym Individual.
- Qualified_Person_Responsible_For_Pharmacovigilance type Person.
- Qualified_Person_Responsible_For_Pharmacovigilance comment "In the European Union, the Qualified Person Responsible For Pharmacovigilance (QPPV) is an individual, usually an employee of a pharmaceutical company, who is personally responsible for the safety of the human pharmaceutical products marketed by that company in the EU. This function was established in 2004 by article 23 of regulation (EC) No 726/2004.".
- Qualified_Person_Responsible_For_Pharmacovigilance label "Qualified Person Responsible For Pharmacovigilance".
- Qualified_Person_Responsible_For_Pharmacovigilance sameAs Q7268654.
- Qualified_Person_Responsible_For_Pharmacovigilance sameAs m.09gjnht.
- Qualified_Person_Responsible_For_Pharmacovigilance sameAs Q7268654.
- Qualified_Person_Responsible_For_Pharmacovigilance wasDerivedFrom Qualified_Person_Responsible_For_Pharmacovigilance?oldid=538350969.
- Qualified_Person_Responsible_For_Pharmacovigilance isPrimaryTopicOf Qualified_Person_Responsible_For_Pharmacovigilance.