The EDQM, a leading organisation that protects public health PDF Download
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Author: Council of Europe
Publisher: Council of Europe
ISBN:
Category : Political Science
Languages : en
Pages : 28
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Book Description
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.
Author: Council of Europe
Publisher: Council of Europe
ISBN:
Category : Political Science
Languages : en
Pages : 28
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Book Description
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.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264805907
Category :
Languages : en
Pages : 447
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Book Description
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.
Author: Divya Vohora
Publisher: Academic Press
ISBN: 0128020989
Category : Medical
Languages : en
Pages : 527
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Book Description
Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery
Author: Dahl, Anne
Publisher: Nordic Council of Ministers
ISBN: 9289371897
Category : Technology & Engineering
Languages : en
Pages : 270
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Book Description
Available online: https://pub.norden.org/temanord2021-547/ The Finnish presidency project on data exchange "Achieving the World's Smoothest Cross-Border Mobility and Daily Life Through Digitalisation" (2021–2023) has produced this baseline study report. The report outlines the current situation of cross-border data exchange between authorities in the Nordic and Baltic countries, while focusing on the three work packages of the presidency project: Studying in another Nordic-Baltic country, using health services in another Nordic-Baltic country, and the versatile use of the Nordic-Baltic legislative databases. Additionally, the barriers to cross-border data exchange was assessed based on the four interoperability layers of the European Interoperability Framework: legal, organisational, semantic and technical interoperability. The report will form the basis of the continued work of the presidency project.
Author:
Publisher:
ISBN: 9789241209021
Category : Drugs
Languages : en
Pages : 208
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Book Description
Author: Ved Srivastava
Publisher: Royal Society of Chemistry
ISBN: 1788014332
Category : Science
Languages : en
Pages : 572
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Book Description
Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis. Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability. This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.
Author: WHO Expert Committee on Biological Standardization. Meeting
Publisher:
ISBN: 9789241209328
Category : Medical
Languages : en
Pages : 137
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Book Description
The Committee reports on general issues discussed and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors and endocrinological substances. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains guidelines on the production and quality control of candidate tetravalent dengue virus vaccines and recommendations for the preparation, characterisation and establishment of international and other biological reference standards.
Author: Council of Europe
Publisher: Manhattan Publishing Company
ISBN:
Category : Medical
Languages : en
Pages : 184
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Book Description
Author: WHO Expert Committee on Biological Standardization. Meeting
Publisher: World Health Organization
ISBN: 9241209771
Category : Medical
Languages : en
Pages : 241
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Book Description
This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices. The second part of the report, of particular relevance to manufacturers and national regulatory authorities, contains revised WHO recommendations for production and control of live attenuated influenza vaccines and for production and control of pneumococcal conjugate vaccines. New WHO guidelines on the regulatory evaluation of similar biotherapeutic medicines are also provided. Also included are a list of recommendations, guidelines and other documents for biological substances used in medicine, and of international standards and reference reagent for biological substances.
Author: Stefanie Schmahl
Publisher: Oxford University Press
ISBN: 0191653144
Category : Law
Languages : en
Pages : 1110
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Book Description
The Council of Europe, of which all European States are members, plays a pivotal role in the promotion and protection of human rights, democracy, and the rule of law in Europe. Bringing together specialist scholars and practitioners, The Council of Europe: Its Laws and Policies offers profound insights into the functioning of the organization. The organization's primary and secondary law, its institutional structure, and its far-reaching fields of activities are comprehensively and systematically analysed. This volume investigates the impact of the Council's activities within the national legal systems of the Member States and the dense web of relationships between the Council of Europe and other international organisations. An important reference work on one of the most influential organizations in Europe, the book concludes that the Council of Europe has played a considerable role in the constitutionalization process of regional public international law.
