Name: The Interplay of Global Standards and Eu Pharmaceutical Regulation: The International Council for Harmonisation (en Inglés)
Price: 165700.00 CLP
Availability: InStock
Author: Murphy, Thérèse ; Röttger-Wirtz, Sabrina ; Hervey, Tamara
ISBN: 9781509942992

portada The Interplay of Global Standards and Eu Pharmaceutical Regulation: The International Council for Harmonisation (en Inglés)

Formato

Libro Físico

Autor

Sabrina Röttger-Wirtz

Editorial

Bloomsbury Publishing PLC

Idioma

Inglés

N° páginas

256

Encuadernación

Tapa Dura

Dimensiones

23.4 x 15.6 x 1.6 cm

Peso

0.53 kg.

ISBN13

9781509942992

Categorías

Derecho administrativo y administraciones públicas
Derecho médico sanitario

The Interplay of Global Standards and Eu Pharmaceutical Regulation: The International Council for Harmonisation (en Inglés)

Sabrina Röttger-Wirtz (Autor) · Bloomsbury Publishing PLC · Tapa Dura

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Reseña del libro "The Interplay of Global Standards and Eu Pharmaceutical Regulation: The International Council for Harmonisation (en Inglés)"

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.