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  1. List of Excluded Studies - Safety of Vaccines Used for Routine Immunization in the United States: An Update - NCBI ... 
    https://www.ncbi.nlm.nih.gov/books/NBK572039
    ... 18th Annual Meeting of the International Society of Pharmacovigilance, ISoP 2018. Switzerland. 41(11):1198. doi: 10. ... in Iraq: A retrospective study based on Iraqi pharmacovigilance database. Iraqi Journal of Pharmaceutical Sciences. 2019;28( ...
  2. Use of Registries in Product Safety Assessment - Registries for Evaluating Patient Outcomes - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK208606
    ... questions. In Europe, in response to concerns over pharmacovigilance, marketing authorization applicants are required to submit a ... undertaken. While many products will require only routine pharmacovigilance, for others more proactive methods of pharmacovigilance will ...
  3. Proactive Postmarketing Surveillance: Overview and Lessons Learned from Medication Safety Research in the Veterans ... 
    https://www.ncbi.nlm.nih.gov/books/NBK43650
    ... data for proactive medication safety surveillance, or enhanced pharmacovigilance studies, is based on the ability of researchers ... than adverse drug reactions. The FDA has defined pharmacovigilance as “all post-approval scientific and data gathering ...
  4. Excluded clinical studies - Drug Allergy - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK274133
    ... MC, Dumas F, Demoly P. Accuracy of a pharmacovigilance algorithm in diagnosing drug hypersensitivity reactions. Archives of ... in systematic review Machado D, Gomes E. Are pharmacovigilance algorithms trustful for the diagnosis of drug hypersensitivity? ...
  5. Adverse Event Detection, Processing, and Reporting - Registries for Evaluating Patient Outcomes - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK208615
    ... product directly to FDA. As standard practice in pharmacovigilance, many sponsors report events potentially associated with another ... the product development cycle and as part of pharmacovigilance; however, other coding systems are also used. For ...
  6. Adverse Event Detection, Processing, and Reporting - Registries for Evaluating Patient Outcomes: A User’s Guide - NCBI .... 
    https://www.ncbi.nlm.nih.gov/books/NBK562574
    ... product directly to FDA. As standard practice in pharmacovigilance, many sponsors report events potentially associated with another ... the product development cycle and as part of pharmacovigilance; however, other coding systems are also used. For ...
  7. Digital Health and Patient Registries: Today, Tomorrow, and the Future - 21st Century Patient Registries - NCBI ... 
    https://www.ncbi.nlm.nih.gov/books/NBK493822
    ... technologies are being used to perform disease and pharmacovigilance surveillance. Recently, in Cambodia, mobile phone-based, SMS text messages were used to conduct pharmacovigilance on 17 different vaccines. 30 Their intention was ...
  8. List of Excluded Studies - Diabetes Medications for Adults With Type 2 Diabetes: An Update - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK362864
    ... pioglitazone in France: a study using the French PharmacoVigilance database. BMC Clin Pharmacol. 2011; 11 :5. Background ... McNair D, Mattison D, et al. Clinical and pharmacovigilance approaches for exploring an electronic medical record dataset ...
  9. Direct-to-Patient Registry and Other Patient-Centric Designs - 21st Century Patient Registries - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK493817
    ... pilot study to test new methods of conducting pharmacovigilance from the Pharmacoepidemiological Research on Outcomes of Therapeutics ... be used for regulatory submission to satisfy the pharmacovigilance obligations of pharmaceutical companies who have marketed products. ...
  10. How this guideline was developed - Medicines Optimisation - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK355914
    ... Hansen EH. (2009) Information about ADRs explored by pharmacovigilance approaches: a qualitative review of studies on antibiotics, ... Trontell A. (2004) Expecting the unexpected – Drug safety, pharmacovigilance and the prepared mind. New England Journal of ...
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