Patient-Reported Safety Information: A Renaissance of Pharmacovigilance?
Author:
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Pharmacology,Toxicology
Link
http://link.springer.com/content/pdf/10.1007/s40264-016-0441-x.pdf
Reference58 articles.
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2. Directive 2010/84/EU. Official Journal of the European Union 2010; L. 348-74-99.
3. Regulation 1235/2010. Official Journal of the European Union 2010; L. 348-1-16.
4. CIOMS Working group VIII. Practical aspects of signal detection in pharmacovigilanc: report of CIOMS Working group VIII. Geneva: CIOMS; 2010.
5. van Hunsel F, Talsma A, van Puijenbroek E, de Jong-van den Berg L, van Grootheest K. The proportion of patient reports of suspected ADRs to signal detection in the Netherlands: case-control study. Pharmacoepidemiol Drug Saf. 2011;20:286–91.
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