Translation of "Version finale de la norme internationale " (French → English) :

Differences between this Regulation and the International Standards contained in Annex 11 to the Convention on International Civil Aviation, as amended’.

(47) The rules on clinical investigations should be in line with major international guidance in this field, such as the international standard ISO 14155:2011 or any subsequent version of it on good clinical practice for clinical investigations of medical devices for human subjects and the most recent version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects ...[+++] to ensure that clinical investigations conducted in the Union are accepted elsewhere and that clinical investigations conducted outside the Union in accordance with international guidelines can be accepted under this Regulation.

(47) The rules on clinical investigations should be in line with major international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects and the most recent (2008) version of the World Medical Association Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects to ensure that clinical ...[+++]investigations conducted in the Union are accepted elsewhere and that clinical investigations conducted outside the Union in accordance with international guidelines can be accepted under this Regulation.

10. Emphasises the need to strengthen the credibility, stability, independence and effectiveness of institutions, thereby guaranteeing democracy and the rule of law and promoting a consensual constitutional reform process based on the clear separation of powers and effective checks and balances between state institutions; stresses that cooperation with the European Commission for Democracy through Law (Venice Commission) is crucial to ensure that the legislative reform packages that are currently being developed are fully consistent with European standards and values; calls on all the relevant political stakeholders, including the government and opposition, to take part in this process, calls on the Ukrainian authorities to ask the Venice ...[+++] Commission for an opinion on the final versions of draft laws;

After lengthy negotiations in committee, I support the final version of our motion for a resolution, which contains many key elements, including the systematic training of the Afghan security forces, greater focus on the rebuilding of civil society and enhanced coordination between the international bodies.

On top of that – and I think Commissioner McCreevy was entirely right here – the current proposal is for nothing more than a slimmed-down version of what are, by any measure, extremely complicated international standards, entirely unsuited to the structure of small and medium-sized companies in Europe.