Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-524"
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"en.20100921.18.2-524"2
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"Pharmacovigilance is an important part of the system protecting patient health, reducing the risks and increasing the benefits of medicines. It is particularly important to assess and monitor the safety of medicines in the first years after they are brought into use. Within the framework of the licensing process, before medicines are actually put on the market, the information from preclinical and clinical studies is assessed first and foremost. However, many possible side effects cannot be discovered until after a medicine has been brought into use. In this context, it is patients who play an important role along with health workers in identifying adverse effects or the suspicion of such effects. However, it is equally important to have an expert assessment of this information, particularly in view of the frequently causal relationship between an adverse effect and the administration of a medicine. I therefore support the new element strengthening the position of patients by enabling them to get actively involved in the process of reporting adverse effects and a high quality evaluation system. In the Czech Republic, patients already have this option on the web portal of the State Institute for Drug Control, which I consider to be an example of good practice for those Member States where such an option does not yet exist."@en1
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