The contribution of direct patient reported ADRs to drug safety signals in the Netherlands from 2010 to 2015

Author:

van Hunsel Florence1ORCID,de Waal Susan12,Härmark Linda1

Affiliation:

1. Netherlands Pharmacovigilance Centre Lareb; WHO Collaborating Centre For Pharmacovigilance In Education And Patient Reporting; 's-Hertogenbosch The Netherlands

2. Pharmaceutical Business Administration, Institute for Allied Healthcare; Utrecht University of Applied Sciences; Utrecht the Netherlands

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Reference26 articles.

1. Evaluation of FDA safety-related drug label changes in 2010;Lester;Pharmacoepidemiol Drug Saf,2013

2. A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee;Pacurariu;Drug Saf,2014

3. CIOMS Working Group VIII Practical aspects of signal detection in pharmacovigilance: report of CIOMS working group VIII 2010

4. The validity and reliability of a signal impact assessment tool;Rolfes;Pharmacoepidemiol Drug Saf,2016

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