Evaluating the effectiveness of risk minimisation measures: the application of a conceptual framework to Danish real-world dabigatran data-Reference-Cited by-同舟云学术

Evaluating the effectiveness of risk minimisation measures: the application of a conceptual framework to Danish real-world dabigatran data

Published:2017-04-11 Issue:6 Volume:26 Page:607-614
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Nyeland Martin Erik¹,Laursen Mona Vestergaard¹,Callréus Torbjörn¹²

Affiliation:

1. Danish Medicines Agency; Copenhagen Denmark

2. Copenhagen Center for Regulatory Science; Copenhagen Denmark

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference28 articles.

1. Post-approval evaluation of effectiveness of risk minimisation: methods, challenges and interpretation;Banerjee;Drug Saf,2014

2. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use Off J Eur Union 2010 L 348 74 99

3. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products Off J Eur Union 2010 L 348 1 16

4. Methodological approaches to evaluate the impact of FDA drug safety communications;Kesselheim;Drug Saf,2015

Cited by 17 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. The use of implementation science theories, models, and frameworks in implementation research for medicinal products: A scoping review;Health Research Policy and Systems;2024-01-29

2. Views from Academia, Industry, Regulatory Agencies, and the Legal System;Textbook of Pharmacoepidemiology;2021-11-15

3. Effectiveness of drug safety measures for reducing the incidence of adverse drug reactions: Post-hoc analysis of data from all-case surveillance of iguratimod using generalized estimating equations;PLOS ONE;2021-07-30

4. Risk Management for the 21st Century: Current Status and Future Needs;Drug Safety;2021-02-09

5. Risk Minimisation Evaluation with Process Indicators and Behavioural or Health Outcomes in Europe: Systematic Review;Pharmaceutical Medicine;2020-11-03