Detalles de la búsqueda
1.
HARmonized Protocol Template to Enhance Reproducibility of hypothesis evaluating real-world evidence studies on treatment effects: A good practices report of a joint ISPE/ISPOR task force.
Pharmacoepidemiol Drug Saf
; 32(1): 44-55, 2023 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-36215113
2.
HARmonized Protocol Template to Enhance Reproducibility of Hypothesis Evaluating Real-World Evidence Studies on Treatment Effects: A Good Practices Report of a Joint ISPE/ISPOR Task Force.
Value Health
; 25(10): 1663-1672, 2022 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-36241338
3.
What are the patients' and health care professionals' understanding and behaviors towards adverse drug reaction reporting and additional monitoring?
Pharmacoepidemiol Drug Saf
; 30(3): 334-341, 2021 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-33099846
4.
Does additional monitoring status increase the reporting of adverse drug reactions? An interrupted time series analysis of EudraVigilance data.
Pharmacoepidemiol Drug Saf
; 30(3): 350-359, 2021 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-33197106
5.
Exploring the opportunities for alignment of regulatory postauthorization requirements and data required for performance-based managed entry agreements.
Int J Technol Assess Health Care
; 37(1): e83, 2021 Aug 23.
Artículo
en Inglés
| MEDLINE | ID: mdl-34424152
6.
Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines.
Br J Clin Pharmacol
; 86(6): 1034-1051, 2020 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-32162368
7.
Navigating stormy waters: 10 years of operation of the European Union Regulatory Network Incident Management Plan for Medicines for Human Use.
Pharmacoepidemiol Drug Saf
; 29(11): 1343-1352, 2020 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-32954565
8.
Graphical Depiction of Longitudinal Study Designs in Health Care Databases.
Ann Intern Med
; 170(6): 398-406, 2019 03 19.
Artículo
en Inglés
| MEDLINE | ID: mdl-30856654
9.
A European multicentre drug utilisation study of the impact of regulatory measures on prescribing of codeine for pain in children.
Pharmacoepidemiol Drug Saf
; 28(8): 1086-1096, 2019 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-31219227
10.
European Medicines Agency seeks stakeholders' views on future transparency measures for clinical trials.
Br J Clin Pharmacol
; 89(8): 2338-2340, 2023 08.
Artículo
en Inglés
| MEDLINE | ID: mdl-37345382
11.
An algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilance.
Pharmacoepidemiol Drug Saf
; 27(1): 38-45, 2018 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-29143393
12.
Is patient exposure preapproval and postapproval a determinant of the timing and frequency of occurrence of safety issues?
Pharmacoepidemiol Drug Saf
; 27(2): 168-173, 2018 02.
Artículo
en Inglés
| MEDLINE | ID: mdl-29278866
13.
Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.
Pharmacoepidemiol Drug Saf
; 26(12): 1442-1450, 2017 Dec.
Artículo
en Inglés
| MEDLINE | ID: mdl-28345151
14.
Geographical variation in reporting Interstitial Lung Disease as an adverse drug reaction: findings from an European Medicines Agency analysis of reports in EudraVigilance.
Pharmacoepidemiol Drug Saf
; 25(6): 705-12, 2016 06.
Artículo
en Inglés
| MEDLINE | ID: mdl-27004571
15.
Measuring the impact of risk communications: Robust analytical approaches are key.
Br J Clin Pharmacol
; 86(4): 635-636, 2020 04.
Artículo
en Inglés
| MEDLINE | ID: mdl-32064646
16.
Increasing scientific standards, independence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.
Pharmacoepidemiol Drug Saf
; 21(7): 690-696, 2012 Jul.
Artículo
en Inglés
| MEDLINE | ID: mdl-22522622
17.
A natural language processing approach towards harmonisation of European medicinal product information.
PLoS One
; 17(10): e0275386, 2022.
Artículo
en Inglés
| MEDLINE | ID: mdl-36264941
18.
The Impact of Mandatory Reporting of Non-Serious Safety Reports to EudraVigilance on the Detection of Adverse Reactions.
Drug Saf
; 45(1): 83-95, 2022 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-34881404
19.
European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance.
Pharmacoepidemiol Drug Saf
; 20(10): 1021-9, 2011 Oct.
Artículo
en Inglés
| MEDLINE | ID: mdl-22039593
20.
The Certainty Framework for Assessing Real-World Data in Studies of Medical Product Safety and Effectiveness.
Clin Pharmacol Ther
; 109(5): 1189-1196, 2021 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-32911562