Improving the Safety of Medicines in the European Union: From Signals to Action-Reference-Cited by-同舟云学术

Improving the Safety of Medicines in the European Union: From Signals to Action

Published:2019-12-06 Issue:3 Volume:107 Page:521-529
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin. Pharmacol. Ther.

Author:

Potts Joanne¹,Genov Georgy¹,Segec Andrej¹,Raine June²,Straus Sabine³⁴,Arlett Peter¹

Affiliation:

1. Pharmacovigilance and Epidemiology Department European Medicines Agency (EMA) Amsterdam The Netherlands

2. Medicines and Healthcare Products Regulatory Agency (MHRA) London UK

3. Medicines Evaluation Board (MEB) Utrecht The Netherlands

4. EMA Pharmacovigilance Risk Assessment Committee (PRAC) Amsterdam The Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1678

Reference21 articles.

1. Observational Research, Randomised Trials, and Two Views of Medical Science

2. 2018 Annual Report on EudraVigilance for the European Parliament the Council and the Commission. EUROPEAN MEDICINES AGENCY (2019). Accessed November 27 2019.

3. Promoting and Protecting Public Health: How the European Union Pharmacovigilance System Works

4. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. EUROPEAN COMMISSION (2012). Accessed November 27 2019.

5. Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency. EUROPEAN COMMISSION (2019). Accessed November 27 2019.

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