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The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964). The 37 member states and European Union (EU) that have signed the Convention are committed to achieving harmonisation of the quality of medicines throughout the European continent and beyond. This brochure presents the activities of the EDQM.
Pharmaceutical Medicine provides an accessible, user-friendly and up-to-date guide for those involved in clinical trials or marketing of new medicines in the pharmaceutical industry.
This guide is intended to provide general provisions and recommendations to assist national policy makers and to enhance the harmonisation of technical standards among the States Parties to the Convention on the Elaboration of a European Pharmacopoeia
People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and ...
This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.
Health at a Glance: Europe 2018 presents comparative analyses of the health status of EU citizens and the performance of the health systems of the 28 EU Member States, 5 candidate countries and 3 EFTA countries.
Incorporating HC 1030-i to iii.
While there may be consensus on the broader issues of the core objectives of the health care system, expectations differ between EU countries, and European national policy-makers. This book seeks firstly to assess the impact of the enlargement process and then to analyse the challenges that lie ahead in the field of health and health policy.