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Produktbild: The Interplay of Global Standards and Eu Pharmaceutical Regulation

The Interplay of Global Standards and Eu Pharmaceutical Regulation The International Council for Harmonisation

Aus der Reihe Hart Studies in Law and Health

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Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

23.09.2021

Herausgeber

Thérèse Murphy + weitere

Verlag

Hart Publishing

Seitenzahl

256

Maße (L/B/H)

24/16,1/1,8 cm

Gewicht

543 g

Sprache

Englisch

ISBN

978-1-5099-4299-2

Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

23.09.2021

Herausgeber

Verlag

Hart Publishing

Seitenzahl

256

Maße (L/B/H)

24/16,1/1,8 cm

Gewicht

543 g

Sprache

Englisch

ISBN

978-1-5099-4299-2

Herstelleradresse

Libri GmbH
Europaallee 1
36244 Bad Hersfeld
DE

Email: gpsr@libri.de

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  • Produktbild: The Interplay of Global Standards and Eu Pharmaceutical Regulation

  • Introduction
    I. EU Pharmaceutical Regulation in a Globalised Market
    II. Global Standards: Questions of Legitimacy
    III. The Contribution of this Book: The Influence of Global Standards through the EU Lens
    IV. The Structure of this Book

    PART I
    1. Regulating Pharmaceuticals in the European Union: Law and Administrative Rule-Making
    I. EU Pharmaceutical Regulation: Past and Present
    II. The Core of the Regulatory Framework: The Marketing Authorisation Procedures
    III. The Role of Administrative Rule-Making in EU Pharmaceutical Regulation
    IV. Conclusion: Incremental Integration, Extensive (Risk) Regulation and the Significance of Administrative Guidance
    2. EU Risk Regulation in a Globalised World: Global Standards
    I. The Phenomenon of Global Standard-Setting
    II. The Institutional Landscape of Global Standard-Setting
    III. The Interplay between Global Standards and EU Risk Regulation
    IV. Conclusion: Institutional Diversity in the Face of Regulatory Complexity
    3. The International Council for Harmonisation: Pharmaceutical Standard-Setting on the Global Level
    I. Pharmaceutical Regulation in a Globalised World: The History of the ICH
    II. The ICH: Mandate and Membership
    III. The ICH: Institutional Structure
    IV. The Standard-Setting Process
    V. Conclusion: The Reformed ICH in Perspective
    4. The Implementation of ICH Standards in the European Union
    I. A Closer Look at the ICH Guidelines
    II. Implementing Global Standards in the EU: The Integration of ICH Standards in EU Pharmaceutical Law
    III. The Influence of ICH Guidelines on Legislation, Commission Guidelines and the Court of Justice
    IV. Conclusion: ICH Guidelines as Integral Parts of the EU Regulatory Framework for Pharmaceuticals

    PART II
    5. Questioning the Legitimacy of Global Standards
    I. Why Should the Legitimacy of Global Standards Be Examined?
    II. What Constitutes Legitimacy on the Global Level?
    III. Administrative Law and Global Standards
    IV. Applying the Perspective of European Administrative Law
    V. Conclusion: In Search of Legitimacy
    6. Examining the Legitimacy of the ICH Standard-Setting Procedure and Uploading EU Administrative Law
    I. The Principle of Participation
    II. The Principle of Independent Expertise
    III. The Principle of Transparency
    IV. Discussing Remedies: The Introduction of Ex-ante and Ex-post Procedures in the Process of Implementation
    V. Conclusion: Undermining and Uploading Procedural Standards
    7. Global Pharmaceutical Standards as a Challenge for EU Law: Remedies within the EU
    I. Political Accountability within the EU for Global Pharmaceutical Standards: A Remedy with Limits
    II. Legal Accountability: Judicial Review of ICH Guidelines within the EU
    III. A Broader Perspective: Global Standards as a Challenge for European Law - The Potential for Juridification
    IV. Conclusion: Accountability Gaps and Juridification
    Conclusion
    I. Pharmaceutical Regulation in a Globalised World
    II. The Legitimacy of Global Pharmaceutical Standards
    III. Lessons Learned from 'Uploading' EU Law to the ICH
    IV. The Implementation of Global Standards as a Legitimacy Challenge for the EU