Sabrina Röttger-Wirtz – författare
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5 produkter
5 produkter
Inbunden, Engelska, 2021
1 220 kr
Skickas inom 10-15 vardagar
This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy.Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union’s reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.
E-bok
Engelska, 2021599 kr
Läs direkt efter köp
This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union''s reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.
E-bok
PDF, Engelska, 2021578 kr
Läs direkt efter köp
This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union''s reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.
Häftad, Engelska, 2023
556 kr
Skickas inom 10-15 vardagar
This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy.Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union’s reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.
Inbunden, Engelska, 2025
1 788 kr
Skickas inom 5-8 vardagar
This book examines the interplay between global standards and the EU legal system, examining how the process of incorporating technical standards set at international level poses challenges for principles of good governance, such as accountability, participatory openness and transparency. It contributes to the ongoing debate concerning the democratic credentials of decision-making in Europe by focusing on the specific juncture where globally produced standards are used by the EU institutions for EU regulatory purposes.Renowned experts delve into the process of incorporation of global standards into salient EU policy areas including agriculture, environment, finance, telecommunications and transport. They shed light on relevant case law and EU legislation, providing unique reflections on the interactions between global and EU governance. Chapters explore the membership and procedural rules of global standard-setting bodies and discuss the patterns of incorporation of standards produced by diverse global regulators. They also present critical insights into horizontal issues, focussing on the role of agencies as in-betweeners, the role of the Court of Justice of the EU, and the bottom-up approach to standardisation via EU member states.Global Standards and EU Law is designed for students and academics in European law and governance. The focus on global standards makes this an essential read for policymakers and practitioners in EU and US administrative law.