Local view for "http://purl.org/linkedpolitics/eu/plenary/2010-09-21-Speech-2-500"

Predicate	Value (sorted: default)
rdf:type	lpv_eu:Speech2
dcterms:Date	"2010-09-21"^^xsd:date2
dcterms:Is Part Of	lp_eu:Pharmacovigilance of medicinal products (amendment of Regulation (EC) No 726/2004) - Pharmacovigilance (amendment of Directive 2001/83/EC) (debate)2
dcterms:Language	"it"^^xsd:language2
lpv:document identification number	"en.20100921.18.2-500"2
lpv:hasSubsequent	lp_eu:2010-09-21-Speech-2-5012
lpv:speaker	lp:Paolo Bartolozzi2
lpv:spokenAs	member; EPP (2009-07-14--2014-06-30)3 chair; Delegation to the EU-Kazakhstan, EU-Kyrgyzstan and EU-Uzbekistan Parliamentary Cooperation Committees, and for relations with Tajikistan, Turkmenistan and Mongolia (2009-09-29--2014-06-30)3 unknown; Il Popolo della Libertà (2009-07-14--2013-12-09)3 member; ENVI (2009-07-16--2012-01-18)3 substitute; JURI (2009-07-16--2012-01-18)3 member; Conference of Delegation Chairs (2009-09-29--2014-06-30)3 substitute; Delegation for relations with the countries of Central America (2009-09-16--2014-06-30)3
lpv:translated text	"Mr President, Commissioner, ladies and gentlemen, this measure sets out to reinforce and rationalise the system of pharmacovigilance in the European Union: these are the ambitious goals set by the McAvan reports, which aim to amend Regulation (EC) No 726/2004 and Directive 2001/83/EC respectively. Thanks to a close and effective working relationship between the European Council and Parliament, and between the parliamentary committees responsible for this area, we have reached the point where we are able today to discuss a proposal that aims to improve the EU pharmacovigilance system, and to conclude the consistent work that the European Union has carried out in this field over more than a decade. Simplification, transparency and rationalisation may be considered the key points of these two reports, which propose measures aiming to guarantee the best possible protection of public health on the basis of standards that are harmonised throughout Europe. Reference is made to an extensive series of actions, ranging from better definition of the roles and responsibilities of the main national and international stakeholders seeking to ensure a new, more informed and active involvement of patients, who are given a fundamental role in the system, to the increased transparency of information concerning the safety of medicinal products and the simplification of activities involved in communicating, recording and evaluating suspected adverse reactions. The current pharmacovigilance system must also be improved through closer cooperation at European, national and regional levels. Effective participation at all three of these levels will, in fact, ensure a profitable exchange of information on the side effects of medicinal products. When reorganised as a network, with Internet support, the new pharmacovigilance system will be able to ensure a high level of information sharing and security to benefit patients, national authorities and healthcare professionals."@en1
lpv:videoURI	<go to Events_and_structure europarl>2

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