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Author: Council of Europe Publisher: Council of Europe ISBN: Category : Political Science Languages : en Pages : 28
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
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: Divya Vohora Publisher: Academic Press ISBN: 0128020989 Category : Medical Languages : en Pages : 527
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: OECD Publisher: OECD Publishing ISBN: 9264805907 Category : Languages : en Pages : 447
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: World Health Organization Publisher: World Health Organization ISBN: 9240091033 Category : Business & Economics Languages : en Pages : 382
Book Description
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines and provision of global regulatory tools. The Expert Committee develops standards through worldwide consultation and an international consensus-building process. The following new guidance texts were adopted and recommended for use: WHO good manufacturing practices for excipients used in pharmaceutical products (revision); IAEA/WHO good manufacturing practices for in-house cold kits for radiopharmaceutical preparations (new); WHO good practices for pharmaceutical quality control laboratories (revision); WHO/UNFPA female condom generic specification (new); WHO Biowaiver List: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release (updated), solid oral dosage forms; WHO guideline on Biopharmaceutics Classification System-based biowaivers (revision); and Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability (republished). All of the above are included in this report and recommended for implementation.
Author: Dahl, Anne Publisher: Nordic Council of Ministers ISBN: 9289371897 Category : Technology & Engineering Languages : en Pages : 270
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: Institute of Medicine Publisher: National Academies Press ISBN: 0309269393 Category : Medical Languages : en Pages : 377
Book Description
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
Author: Ved Srivastava Publisher: Royal Society of Chemistry ISBN: 1788018699 Category : Science Languages : en Pages : 572
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: Stefanie Schmahl Publisher: Oxford University Press ISBN: 0191653144 Category : Law Languages : en Pages : 1110
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.
Author: Council of Europe
Author: Council of Europe
Author: Divya Vohora
Author: OECD
Author: World Health Organization
Author: Dahl, Anne
Author: 
Author: Institute of Medicine
Author: Ved Srivastava
Author: Stefanie Schmahl
Author: Council of Europe