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03687aam a2200433 i 4500 001 045A9D725F0811ECA70E6FDD2BECA4DB 003 SILO 005 20211217010126 008 210412t20212021enk b 001 0 eng 010 $a 2021017140 020 $a 1509943080 020 $a 9781509943081 020 $a 1509942998 020 $a 9781509942992 035 $a (OCoLC)1224246898 040 $a DLC $b eng $e rda $c DLC $d OCLCO $d OCLCF $d UKMGB $d YDX $d GWL $d SILO 042 $a pcc 043 $a e------ 050 00 $a KJE6191 $b .R68 2021 100 1 $a RoÂttger-Wirtz, Sabrina, $e author. 245 14 $a The interplay of global standards and EU pharmaceutical regulation : $b the International Council for Harmonisation / $c Sabrina RoÂttger-Wirtz. 264 1 $a Oxford, UK ; $b Hart Publishing, Bloomsbury Publishing Plc, $c 2021. 300 $a viii, 241 pages ; $c 25 cm. 490 1 $a Hart studies in law and health 500 $a Based on author's thesis (doctoral)--Universiteit Maastricht, 2017. 504 $a Includes bibliographical references (pages 220-236) and index. 505 0 $a Introduction -- Regulating pharmaceuticals in the European Union : law and administrative rule-making -- EU risk regulation in a globalised world : global standards -- The International Council for Harmonisation : pharmaceutical standard-setting on the global level -- The implementation of ICH standards in the European Union -- Questioning the legitimacy of global standards -- Examining the legitimacy of the ICH standard-setting procedure and uploading EU administrative law -- Global pharmaceutical standards as a challenge for EU law : remedies within the EU -- Conclusion. 520 $a "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"-- $c Provided by publisher. 610 20 $a ICH (Association) 650 0 $a Drugs $x Law and legislation $z European Union countries. 650 0 $a International and municipal law $z European Union countries. 650 7 $a Drugs $x Law and legislation. $2 fast $0 (OCoLC)fst00898830 650 7 $a International and municipal law. $2 fast $0 (OCoLC)fst00976759 651 7 $a European Union countries. $2 fast $0 (OCoLC)fst01269470 776 08 $i Online version: $a RoÂettger-Wirtz, Sabrina. $t Interplay of global standards and EU pharmaceutical regulation $d Oxford ; New York : Hart, 2021 $z 9781509943012 $w (DLC) 2021017141 830 0 $a Hart studies in law and health. 941 $a 1 952 $l OVUX522 $d 20231018011100.0 956 $a http://locator.silo.lib.ia.us/search.cgi?index_0=id&term_0=045A9D725F0811ECA70E6FDD2BECA4DBInitiate Another SILO Locator Search