What are the patients' and health care professionals' understanding and behaviors towards adverse drug reaction reporting and additional monitoring?-Reference-Cited by-同舟云学术

What are the patients' and health care professionals' understanding and behaviors towards adverse drug reaction reporting and additional monitoring?

Published:2020-11-08 Issue:3 Volume:30 Page:334-341
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Januskiene Justina¹^ORCID,Segec Andrej¹^ORCID,Slattery Jim¹^ORCID,Genov Georgy¹,Plueschke Kelly¹,Kurz Xavier¹^ORCID,Arlett Peter¹²

Affiliation:

1. Pharmacovigilance and Epidemiology Department, European Medicines Agency Amsterdam HS The Netherlands

2. London School of Hygiene and Tropic Medicine London UK

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/pds.5162

Reference12 articles.

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

2. Under-Reporting of Adverse Drug Reactions

3. Guideline on good pharmacovigilance practices Module X—Additional monitoring. Retrieved from.http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/04/WC500142282.pdf

4. Regulation (EC) No 726/2004 of the European Parliament and of the council of 31 March laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency Official Journal L–136 p. 1–33. Retrieved fromhttp://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:136:0001:0033:en:PDF

5. Report from the Commission to the European Parliament and the Council on the national and European Medicines Agency experience regarding the list of medicines for human use subject to additional monitoring. Retrieved fromhttps://ec.europa.eu/transparency/regdoc/rep/1/2019/EN/COM-2019-591-F1-EN-MAIN-PART-1.PDF

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