Lessons learned on the design and the conduct of Post‐Authorization Safety Studies: review of 3 years of PRAC oversight-Reference-Cited by-同舟云学术

Lessons learned on the design and the conduct of Post‐Authorization Safety Studies: review of 3 years of PRAC oversight

Published:2016-12-07 Issue:4 Volume:83 Page:884-893
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Br J Clin Pharmacol

Author:

Engel Pierre¹,Almas Mariana Ferreira²,De Bruin Marieke Louise³⁴,Starzyk Kathryn⁵,Blackburn Stella²,Dreyer Nancy Ann⁵

Affiliation:

1. Real‐World InsightsQuintilesIMS Saint Ouen France

2. Real‐World InsightsQuintilesIMS Green Park, Reading UK

3. Utrecht Institute for Pharmaceutical Sciences (UIPS), Division of Pharmacoepidemiology and Clinical PharmacologyUtrecht University Utrecht the Netherlands

4. Copenhagen Centre for Regulatory Science (CORS)University of Copenhagen Denmark

5. Real‐World InsightsQuintilesIMS Cambridge MA USA

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.13165

Reference41 articles.

1. 1. European Commission.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. OJ EU2010

2. 2. L/348: 74-99 [online]. Available athttp://eur???lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF(lastaccessed10October2016).

3. 3. European Commission.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. OJ EU2010

4. 4. L348: 1-16 [online]. Available athttp://eur???lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF(lastaccessed10October2016).

5. European Medicines Agency.Pharmacovigilance legislation[online]. Available athttp://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000491.jsp&mid=WC0b01ac058058f32d(last accessed 10 October 2016).

Cited by 37 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. Review of Studies Evaluating Effectiveness of Risk Minimization Measures Assessed by the European Medicines Agency Between 2016 and 2021;Clinical Pharmacology & Therapeutics;2023-10-16

2. Reported congenital malformations after exposure to non‐tumour necrosis factor inhibitor biologics: A retrospective comparative study in EudraVigilance;British Journal of Clinical Pharmacology;2022-08-05

3. Systematic review of guidance for the collection and use of patient-reported outcomes in real-world evidence generation to support regulation, reimbursement and health policy;Journal of Patient-Reported Outcomes;2022-06-02

4. Overview of the European post‐authorisation study register post‐authorization studies performed in Europe from September 2010 to December 2018;Pharmacoepidemiology and Drug Safety;2022-02-11

5. Impact of Changing Regulations and the Dynamic Nature of European Risk Management Plans for Human Medicines on the Lifecycle of Safety Concerns;Pharmaceutical Medicine;2022-01-31