The interplay of global standards and EU pharmaceutical regulation

Research output: ThesisDoctoral ThesisInternal

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Abstract

The PhD research ‘The Interplay of Global Standards and EU Pharmaceutical Regulation’ discusses the EU implementation of pharmaceutical standards set by the International Council for Harmonisation (ICH). It is argued that the process of standard-setting in the ICH does not adhere to the same level of participation, transparency and independence of expertise as would be ensured through administrative procedure in the Union. This leads to legitimacy flaws of the ICH standards. With the implementation of ICH standards in the Union, its flaws are imported as well. These legitimacy flaws are not compensated through the Union’s implementation procedure.
Original languageEnglish
Awarding Institution
  • Maastricht University
Supervisors/Advisors
  • Vos, Ellen, Supervisor
  • Ott, Andrea, Advisor
Award date18 Dec 2017
Place of PublicationMaastricht
Publisher
DOIs
Publication statusPublished - 2017

Keywords

  • ICH standards
  • EU implementation
  • legitimacy flaws

Cite this

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title = "The interplay of global standards and EU pharmaceutical regulation",
abstract = "The PhD research ‘The Interplay of Global Standards and EU Pharmaceutical Regulation’ discusses the EU implementation of pharmaceutical standards set by the International Council for Harmonisation (ICH). It is argued that the process of standard-setting in the ICH does not adhere to the same level of participation, transparency and independence of expertise as would be ensured through administrative procedure in the Union. This leads to legitimacy flaws of the ICH standards. With the implementation of ICH standards in the Union, its flaws are imported as well. These legitimacy flaws are not compensated through the Union’s implementation procedure.",
keywords = "ICH standards, EU implementation, legitimacy flaws",
author = "Sabrina R{\"o}ttger-Wirtz",
year = "2017",
doi = "10.26481/dis.20171218sr",
language = "English",
publisher = "Maastricht University",
school = "Maastricht University",

}

The interplay of global standards and EU pharmaceutical regulation. / Röttger-Wirtz, Sabrina.

Maastricht : Maastricht University, 2017. 327 p.

Research output: ThesisDoctoral ThesisInternal

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AB - The PhD research ‘The Interplay of Global Standards and EU Pharmaceutical Regulation’ discusses the EU implementation of pharmaceutical standards set by the International Council for Harmonisation (ICH). It is argued that the process of standard-setting in the ICH does not adhere to the same level of participation, transparency and independence of expertise as would be ensured through administrative procedure in the Union. This leads to legitimacy flaws of the ICH standards. With the implementation of ICH standards in the Union, its flaws are imported as well. These legitimacy flaws are not compensated through the Union’s implementation procedure.

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