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  1. NLM Digital Collections - Hospital and health administration index (Volume 54) 
    resource.nlm.nih.gov/9601831X4
    ... a case/non-case study in the French pharmacovigilance system database. Moore N, et al. Br J ... care professionals across the European Union. The European Pharmacovigilance Research Group. Belton KJ. Eur J Clin Pharmacol ...
  2. NLM Digital Collections - E2B(R3) electronic transmission of Individual Case Safety Reports (ICSRs) implementation ... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
    resource.nlm.nih.gov/9918469488506676
    ... standard that have a wider scope, such as pharmacovigilance activities related to vaccines, herbal products, cosmetics, veterinary ... primary ICH application is for the exchange of pharmacovigilance information between and among the pharmaceutical industry and ...
  3. NLM Digital Collections - Appendix I (B) to the ICH E2B(R3) ICSRs implementation guide : backwards and forwards ... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
    resource.nlm.nih.gov/9918469488306676
    ... and E2B(R3). 2.0 BACKGROUND The current pharmacovigilance databases are operating largely on the basis of ... have implemented the new guideline and have their pharmacovigilance databases adapted to these new standards. This implies ...
  4. NLM Digital Collections - Hospital and health administration index (Volume 55) 
    resource.nlm.nih.gov/9601831X5
    ... reaction monitoring in Jena—experiences of a regionalized pharmacovigilance centre. Hoffmann A, et al. Exp Toxicol Pathol ... Oct; 89(10): 1567-70 Record-linkage for pharmacovigilance in Scotland. Evans JM, et al. Br J ...
  5. NLM Digital Collections - Development and licensure of vaccines to prevent COVID-19 : guidance for industry 
    Publication: [Silver Spring, MD] : Center for Biologics Evaluation and Research, October 2023
    resource.nlm.nih.gov/9918732188106676
    ... KEY CONSIDERATIONS .................. 16 A. General Considerations .................................................................................................... 16 B. Pharmacovigilance Activities for COVID-19 Vaccines ................................................. 16 C. Required ... vaccine is licensed. • FDA recommends early planning of pharmacovigilance activities before licensure. • To facilitate accurate recording and ...
  6. NLM Digital Collections - Hospital literature index (Volume 50) 
    resource.nlm.nih.gov/7807587X37
    ... 1015-22 Dealing with variability: the role of pharmacovigilance. Waller PC. J Pharm Pharmacol 1994 May; 46 ... Jan 1 ;51 (1 ):79-84 Harmonisation in pharmacovigilance. Edwards IR, et al. Drug Saf 1994 Feb; ...
  7. NLM Digital Collections - Hospital and health administration index (Volume 53) 
    resource.nlm.nih.gov/9601831X3
    ... in: BMJ 1997 Aug 30;315(7107):500. Pharmacovigilance in the 1990s [comment] Lawson DH. Br J ... 10 Drug-induced autoimmunity: experience of the French pharmacovigilance system. Vial T, et al. Toxicology 1997 Apr ...
  8. NLM Digital Collections - Long term follow-up after administration of human gene therapy products 
    Publication: Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
    resource.nlm.nih.gov/101767662
    ... time of your BLA submission you submit a Pharmacovigilance Plan (PVP) as described in the FDA Guidance for Industry; E2E Pharmacovigilance Planning (Ref. 34). Of note, the ongoing or ...
  9. NLM Digital Collections - Pharmacological management of glycaemic control in people with type 2 diabetes : a national ... 
    Publication: Edinburgh, Scotland : Scottish Intercollegiate Guidelines Network (SIGN), November 2017
    resource.nlm.nih.gov/101730372
    ... SE, Bergenstal RM, Bakris 79 European Medicines Agency, Pharmacovigilance Risk Assessment GL, et al. Alogliptin after acute ... 35. Regulation (EC) No 726/2004 resulting from pharmacovigilance data - SGLT 2 inhibitors. London: European Medicines Agency; ...
  10. NLM Digital Collections - Considerations in demonstrating interchangeability with a reference product 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
    resource.nlm.nih.gov/101760108
    ... for an interchangeable product should also have adequate pharmacovigilance mechanisms in place.33 Rare but potentially serious ... the BPCI Act (December 2018). 33 For general pharmacovigilance considerations, see the guidance for industry Good Pharmacovigilance ...
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