Good Manufacturing Practice (GMP) Guidelines

Good Manufacturing Practice (GMP) Guidelines PDF

Author: Mindy J. Allport-Settle

Publisher: Pharmalogika

Published: 2009-12

Total Pages: 686

ISBN-13: 9780982147603

DOWNLOAD EBOOK →

This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.

European Monetary Integration

European Monetary Integration PDF

Author: Paul J.J. Welfens

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 399

ISBN-13: 3642799698

DOWNLOAD EBOOK →

EU monetary integration was reinforced in the 1980s when macroeconomic convergence and a dominant role of the German Bundesbank created the basis for relatively stable exchange rates and increasing EU trade volumes. The analysis here focuses on the EMS crisis of 1992/93, the topic of optimum currency areas and the problem of fiscal policies and regional stabilization in Europe, the US and Canada. This book gives an assessment of the EMS developments and shows how financial market liberalization as well as the EU single market project affect the process of economic and monetary union. The role of currency substitution and problems of the Bundesbank's monetary policy control in a changing international system are evaluated.

The European Social Dialogue Under Articles 138 and 139 of the EC Treaty

The European Social Dialogue Under Articles 138 and 139 of the EC Treaty PDF

Author: Christian Welz

Publisher: Kluwer Law International B.V.

Published: 2008-01-01

Total Pages: 692

ISBN-13: 9041127445

DOWNLOAD EBOOK →

Describes, analyses, and assesses the European social dialogue from a combined theoretical and normative perspective and applies theoretical strands stemming from industrial relations, EC law, and political theory to an understanding and assessment of the genesis, actors, processes, and outcomes of the European social dialogue through 2007

Participation in EU Rule-making

Participation in EU Rule-making PDF

Author: Joana Mendes

Publisher: OUP Oxford

Published: 2011-04-07

Total Pages: 544

ISBN-13: 0191616699

DOWNLOAD EBOOK →

The limited scope of participation in the making of EU law remains a continued source of controversy, featuring prominently in recent institutional and political developments that have been shaping the EU's constitutional framework - most intensely in the follow up of the Commission's White Paper on Governance. Yet little attention has been paid to participation rights as a means of ensuring the procedural protection of persons affected by EU regulation in its diverse forms. This is a dimension of the rule of law that has been largely ignored by EU legislative and judicial bodies. Not only the legislator, but also the Court of Justice and the Court of First Instance tend to adhere to excessively formal conceptions of participation rights that are premised on the right to be heard in individual procedures, as well as to a restrictive view regarding the relationships between the citizens and the administration. This book shows why, in the face of new regulatory developments, these conceptions are currently inadequate to ensure the legal protection of rights and interests affected by EU regulation. Combining a conceptual analysis with thorough empirical scrutiny, this book assesses the scope of participation rights in EU law against their rationales and underlying legal values. It makes a case for the extension of participation rights to new situations and new types of procedures, in particular those that would generally fall within the category of rulemaking. It brings distinct normative insights into a crucial theme of EU administrative law, and makes a topical and timely contribution to the increasingly notable theme of public participation in EU regulation. Joanna Mendes' 2009 thesis upon which Participation in EU Rule-Making is based was awarded the the European University Institute (Florence) Mauro Cappelletti Prize for the best doctoral thesis using a methodology of comparative law