These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.


BIOMARKERS

Molecular Biopsy of Human Tumors

- a resource for Precision Medicine *

155 related articles for article (PubMed ID: 37658281)

  • 1. Duration of Effectiveness Evaluation of Additional Risk Minimisation Measures for Centrally Authorised Medicinal Products in the EU Between 2012 and 2021.
    Essink SCM; Zomerdijk IM; Straus SMJM; Gardarsdottir H; De Bruin ML
    Drug Saf; 2023 Oct; 46(10):1007-1020. PubMed ID: 37658281
    [TBL] [Abstract][Full Text] [Related]  

  • 2. Description of the Risk Management of Medication Errors for Centrally Authorised Products in the European Union.
    Hoeve CE; Francisca RDC; Zomerdijk I; Sturkenboom MCJM; Straus SMJM
    Drug Saf; 2020 Jan; 43(1):45-55. PubMed ID: 31617081
    [TBL] [Abstract][Full Text] [Related]  

  • 3. Introduction or Discontinuation of Additional Risk Minimisation Measures During the Life Cycle of Medicines in Europe.
    Francisca RDC; Baba E; Hoeve CE; Zomerdijk IM; Sturkenboom MCJM; Straus SMJM
    Drug Saf; 2021 Jan; 44(1):63-72. PubMed ID: 33000427
    [TBL] [Abstract][Full Text] [Related]  

  • 4. A descriptive review of additional risk minimisation measures applied to EU centrally authorised medicines 2006-2015.
    Rubino A; Artime E
    Expert Opin Drug Saf; 2017 Aug; 16(8):877-884. PubMed ID: 28548608
    [TBL] [Abstract][Full Text] [Related]  

  • 5. Additional Risk Minimisation Measures for Medicinal Products in the European Union: A Review of the Implementation and Effectiveness of Measures in the United Kingdom by One Marketing Authorisation Holder.
    Agyemang E; Bailey L; Talbot J
    Pharmaceut Med; 2017; 31(2):101-112. PubMed ID: 28413313
    [TBL] [Abstract][Full Text] [Related]  

  • 6. Additional risk minimisation measures in the EU - are they eligible for assessment?
    Zomerdijk IM; Trifirò G; Sayed-Tabatabaei FA; Sturkenboom MC; Straus SM
    Pharmacoepidemiol Drug Saf; 2013 Oct; 22(10):1046-53. PubMed ID: 23946274
    [TBL] [Abstract][Full Text] [Related]  

  • 7. Pharmacovigilance in Europe: Place of the Pharmacovigilance Risk Assessment Committee (PRAC) in organisation and decisional processes.
    Laroche ML; Batz A; Géniaux H; Féchant C; Merle L; Maison P
    Therapie; 2016 Apr; 71(2):161-9. PubMed ID: 27080834
    [TBL] [Abstract][Full Text] [Related]  

  • 8. The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011-2018.
    Schuster Bruce C; Brhlikova P; Heath J; McGettigan P
    PLoS Med; 2019 Sep; 16(9):e1002873. PubMed ID: 31504034
    [TBL] [Abstract][Full Text] [Related]  

  • 9. Risk Minimisation Evaluation with Process Indicators and Behavioural or Health Outcomes in Europe: Systematic Review.
    Artime E; Qizilbash N; Herruzo R; Garrido-Estepa M
    Pharmaceut Med; 2020 Dec; 34(6):387-400. PubMed ID: 33141411
    [TBL] [Abstract][Full Text] [Related]  

  • 10. Impact of Changing Regulations and the Dynamic Nature of European Risk Management Plans for Human Medicines on the Lifecycle of Safety Concerns.
    Holm JEJ; Ruppert JG; Ramsden SD
    Pharmaceut Med; 2022 Feb; 36(1):33-46. PubMed ID: 35099785
    [TBL] [Abstract][Full Text] [Related]  

  • 11. Measuring the impact of the 2012 European pharmacovigilance legislation on additional risk minimization measures.
    Francisca RDC; Zomerdijk IM; Sturkenboom MCJM; Straus SMJM
    Expert Opin Drug Saf; 2018 Oct; 17(10):975-982. PubMed ID: 30107752
    [TBL] [Abstract][Full Text] [Related]  

  • 12. Chaos to Clarity: Pragmatic Approaches to Overcome Challenges for Successful Implementation of Additional Risk Minimisation Measures in the European Union and the UK by a Marketing Authorisation Holder.
    Hapani K; Parikh N; Pianka K; Patel H
    Pharmaceut Med; 2022 Jun; 36(3):173-188. PubMed ID: 35416591
    [TBL] [Abstract][Full Text] [Related]  

  • 13. Risk minimization activities of centrally authorized products in the EU: a descriptive study.
    Zomerdijk IM; Sayed-Tabatabaei FA; Trifirò G; Blackburn SC; Sturkenboom MC; Straus SM
    Drug Saf; 2012 Apr; 35(4):299-314. PubMed ID: 22339506
    [TBL] [Abstract][Full Text] [Related]  

  • 14. A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee.
    Pacurariu AC; Coloma PM; van Haren A; Genov G; Sturkenboom MC; Straus SM
    Drug Saf; 2014 Dec; 37(12):1059-66. PubMed ID: 25398646
    [TBL] [Abstract][Full Text] [Related]  

  • 15. [The new pharmacovigilance legislation in practice].
    Broekmans AW; Mol PG
    Ned Tijdschr Geneeskd; 2014; 158():A7129. PubMed ID: 24846112
    [TBL] [Abstract][Full Text] [Related]  

  • 16. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.
    Bouvy JC; Blake K; Slattery J; De Bruin ML; Arlett P; Kurz X
    Pharmacoepidemiol Drug Saf; 2017 Dec; 26(12):1442-1450. PubMed ID: 28345151
    [TBL] [Abstract][Full Text] [Related]  

  • 17. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.
    Borg JJ; Aislaitner G; Pirozynski M; Mifsud S
    Drug Saf; 2011 Mar; 34(3):187-97. PubMed ID: 21332243
    [TBL] [Abstract][Full Text] [Related]  

  • 18. Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.
    Engel P; Almas MF; De Bruin ML; Starzyk K; Blackburn S; Dreyer NA
    Br J Clin Pharmacol; 2017 Apr; 83(4):884-893. PubMed ID: 27780289
    [TBL] [Abstract][Full Text] [Related]  

  • 19. Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation.
    Banerjee AK; Zomerdijk IM; Wooder S; Ingate S; Mayall SJ
    Drug Saf; 2014 Jan; 37(1):33-42. PubMed ID: 24357107
    [TBL] [Abstract][Full Text] [Related]  

  • 20. [Experimental testing of centrally authorised medicinal products. The CAP programme].
    Giess S
    Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz; 2014 Oct; 57(10):1169-72. PubMed ID: 25159224
    [TBL] [Abstract][Full Text] [Related]  

    [Next]    [New Search]
    of 8.