365 related articles for article (PubMed ID: 31621897)
1. Improving the Safety of Medicines in the European Union: From Signals to Action.
Potts J; Genov G; Segec A; Raine J; Straus S; Arlett P
Clin Pharmacol Ther; 2020 Mar; 107(3):521-529. PubMed ID: 31621897
[TBL] [Abstract][Full Text] [Related]
2. [The new pharmacovigilance legislation in practice].
Broekmans AW; Mol PG
Ned Tijdschr Geneeskd; 2014; 158():A7129. PubMed ID: 24846112
[TBL] [Abstract][Full Text] [Related]
3. 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]
4. New safety signals assessed by the Pharmacovigilance Risk Assessment Committee at EU level in 2014-2017.
Farcaş A; Măhălean A; Bulik NB; Leucuta D; Mogoșan C
Expert Rev Clin Pharmacol; 2018 Oct; 11(10):1045-1051. PubMed ID: 30269618
[TBL] [Abstract][Full Text] [Related]
5. 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]
6. A description of medicines-related safety issues evaluated through a referral procedure at the EU level after 2012.
Farcas A; Balcescu T; Anghel L; Bucsa C; Mogoșan C
Expert Opin Drug Saf; 2020 Jun; 19(6):755-762. PubMed ID: 32186202
[TBL] [Abstract][Full Text] [Related]
7. Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works.
Santoro A; Genov G; Spooner A; Raine J; Arlett P
Drug Saf; 2017 Oct; 40(10):855-869. PubMed ID: 28735357
[TBL] [Abstract][Full Text] [Related]
8. 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]
9. 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]
10. 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]
11. 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]
12. 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]
13. Geographical variation in reporting Interstitial Lung Disease as an adverse drug reaction: findings from an European Medicines Agency analysis of reports in EudraVigilance.
Pinheiro L; Blake K; Januskiene J; Yue QY; Arlett P
Pharmacoepidemiol Drug Saf; 2016 Jun; 25(6):705-12. PubMed ID: 27004571
[TBL] [Abstract][Full Text] [Related]
14. A review of the National pharmacovigilance system in Malta - implementing and operating a pharmacovigilance management system.
Tanti A; Micallef B; Serracino-Inglott A; Borg JJ
Expert Opin Drug Saf; 2017 Jan; 16(1):65-76. PubMed ID: 27732110
[TBL] [Abstract][Full Text] [Related]
15. Interest of pharmacoepidemiology in pharmacovigilance: Post-authorization safety studies in regulatory pharmacovigilance activity.
Abou Taam M; Ferard C; Rocle P; Maison P
Therapie; 2019 Apr; 74(2):301-306. PubMed ID: 30704766
[TBL] [Abstract][Full Text] [Related]
16. Factors distinguishing important identified risks from important potential risks in orphan and nonorphan drugs: An analysis of safety specifications of Japan and European Union risk management plans.
Hirota S; Yamaguchi T
Pharmacoepidemiol Drug Saf; 2018 Nov; 27(11):1231-1238. PubMed ID: 30187590
[TBL] [Abstract][Full Text] [Related]
17. [Direct reporting by patients of adverse drug reactions in Spain].
Esther Salgueiro M; Jimeno FJ; Aguirre C; García M; Ordóñez L; Manso G
Farm Hosp; 2013; 37(1):65-71. PubMed ID: 23461502
[TBL] [Abstract][Full Text] [Related]
18. Current state of biologic pharmacovigilance in the European Union: improvements are needed.
Felix T; Jordan JB; Akers C; Patel B; Drago D
Expert Opin Drug Saf; 2019 Mar; 18(3):231-240. PubMed ID: 30714424
[TBL] [Abstract][Full Text] [Related]
19. The Importance of Direct Patient Reporting of Adverse Drug Reactions in the Safety Monitoring Process.
Sienkiewicz K; Burzyńska M; Rydlewska-Liszkowska I; Sienkiewicz J; Gaszyńska E
Int J Environ Res Public Health; 2021 Dec; 19(1):. PubMed ID: 35010673
[TBL] [Abstract][Full Text] [Related]
20. Signal detection activity on EudraVigilance data: analysis of the procedure and findings from an Italian Regional Centre for Pharmacovigilance.
Monaco L; Melis M; Biagi C; Donati M; Sapigni E; Vaccheri A; Motola D
Expert Opin Drug Saf; 2017 Mar; 16(3):271-275. PubMed ID: 28094583
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
