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Establishing Quality Specifications For Medicines Vaccines And In Vitro Diagnostics
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Book Synopsis Establishing quality specifications for medicines, vaccines and in vitro diagnostics by : World Health Organization
Download or read book Establishing quality specifications for medicines, vaccines and in vitro diagnostics written by World Health Organization and published by World Health Organization. This book was released on 2024-07-10 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The selection and use of essential in vitro diagnostics by :
Download or read book The selection and use of essential in vitro diagnostics written by and published by World Health Organization. This book was released on 2021-01-29 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis First WHO Model List of Essential In Vitro Diagnostics by : World Health Organization
Download or read book First WHO Model List of Essential In Vitro Diagnostics written by World Health Organization and published by World Health Organization. This book was released on 2019-05-16 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt: The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.
Book Synopsis Biotechnology Operations by : John M. Centanni
Download or read book Biotechnology Operations written by John M. Centanni and published by CRC Press. This book was released on 2011-03-22 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Because of rapid developments in the biotechnology industry—and the wide range of disciplines that contribute to its collective growth—there is a heightened need to more carefully plan and fully integrate biotech development projects. Despite the wealth of operations experience and associated literature available, no single book has yet offered a comprehensive, practical guide to fundamentals. Filling the void, Biotechnology Operations: Principles and Practices reflects this integrative philosophy, serving as a practical guide for students, professionals, or anyone else with interests in the biotech industry. Although many books emphasize specific technical aspects of biotech, this is perhaps the first to integrate essential concepts of product development and scientific and management skills with the seven functional areas of biotechnology: Biomanufacturing Clinical trials Nonclinical studies Project management Quality assurance Quality control Regulatory affairs A practical roadmap to optimizing biotechnology operations, this reference illustrates how to use specific product planning, design, and project management processes to seamlessly merge plans and efforts in the key functional areas. Applying lessons learned throughout the nascent history of biotech, author Michael Roy highlights developmental principles that could bring future products to market more safely and efficiently. Drawing from his experiences working in industry and teaching a graduate course at the University of Wisconsin, this hotly anticipated book clarifies basic methodologies and practices to help reduce risks and resolve problems as future technological discoveries are developed into tangible products.
Author :World Health Organization. Expert Committee on Biological Standardization Publisher :World Health Organization ISBN 13 :9241209992 Total Pages :292 pages Book Rating :4.2/5 (412 download)
Book Synopsis WHO Expert Committee on Biological Standardization by : World Health Organization. Expert Committee on Biological Standardization
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization. Expert Committee on Biological Standardization and published by World Health Organization. This book was released on 2016 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 biological substances, and the establishment of international biological reference materials. Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, a WHO guidance document on Regulatory assessment of approved rDNA-derived biotherapeutics was adopted along with WHO Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions and on WHO good manufacturing practices for biological products. In addition, revised WHO Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines were also adopted by the Committee. Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1). The above four WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2-5). Finally, all additions and discontinuations made during the 2015 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 6. The updated full catalog of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Book Synopsis Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance by : World Health Organization
Download or read book Quality assurance of pharmaceuticals: a compendium of guidelines and related materials, tenth edition. Volume 1. Good practices and related regulatory guidance written by World Health Organization and published by World Health Organization. This book was released on 2024-10-24 with total page 1788 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication represents a significant achievement in our ongoing effort to ensure that everyone can reach the highest possible level of health. Over the last three decades, we have seen the transformation of the pharmaceutical industry and the increasing intricacy of the product life cycle. The challenges we face today are very different from those we faced when the first edition of this Compendium was published in 1997. However, our mission remains the same: to promote health, keep the world safe and serve the vulnerable. The new edition reflects the collective knowledge and expertise of countless professionals who have worked diligently to develop, revise, and implement WHO guidelines for pharmaceuticals. This includes experts from WHO, Member States, our Expert Advisory Panels and Expert Committees on Specifications for Pharmaceutical Preparations and other organizations and has undergone extensive consultation with stakeholders worldwide. This Compendium covers development through manufacturing and quality control to post-marketing surveillance. It provides a comprehensive framework for quality assurance that is both strong and flexible, capable of meeting the requirements of a rapidly changing global health landscape. The 10th edition is a collection of knowledge and tools for empowerment, enabling all stakeholders in the pharmaceutical industry to make informed decisions that prioritize patient safety and well-being.
Book Synopsis WHO Expert Committee on Biological Standardization by : World Health Organization
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization and published by World Health Organization. This book was released on 2022-09-30 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 75th meeting of the WHO Expert Committee on Biological Standardization was held from 4 to 8 April 2022 by Zoom video conferencing. The meeting was opened on behalf of the Director-General of WHO by Dr Mariângela Batista Galvao Simão, Assistant Director-General, Access to Medicines and Health Products. The Expert Committee on Biological Standardization reviews developments in the field of biological substances used in human medicine, which include vaccines, biotherapeutics, blood products and related substances, and in vitro diagnostic reagents. It coordinates activities leading to: (a) the adoption of WHO guidelines and recommendations for assuring the quality, safety and efficacy of such substances; and (b) the establishment of WHO international standards and other reference materials. The use of international reference materials for designating the activity of biological substances used in prophylaxis or therapy, or for ensuring the reliability of quality control or diagnostic procedures, allows for the comparison of data worldwide. Target audience includes - but is not limited to - regulators, manufacturers, developers of vaccines and other biological products and academia.
Book Synopsis International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations by : Pierre-Louis Lezotre
Download or read book International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations written by Pierre-Louis Lezotre and published by Academic Press. This book was released on 2013-12-05 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health. The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels) The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area
Author : Publisher :Food & Agriculture Org. ISBN 13 :9251388946 Total Pages :174 pages Book Rating :4.2/5 (513 download)
Download or read book written by and published by Food & Agriculture Org.. This book was released on with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Promoting access to medical technologies and innovation by :
Download or read book Promoting access to medical technologies and innovation written by and published by World Health Organization. This book was released on 2020-08-31 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :WHO Expert Committee on Biological Standardization. Meeting Publisher :World Health Organization ISBN 13 :9241209771 Total Pages :241 pages Book Rating :4.2/5 (412 download)
Book Synopsis WHO Expert Committee on Biological Standardization by : WHO Expert Committee on Biological Standardization. Meeting
Download or read book WHO Expert Committee on Biological Standardization written by WHO Expert Committee on Biological Standardization. Meeting and published by World Health Organization. This book was released on 2013 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Rossi's Principles of Transfusion Medicine by : Toby L. Simon
Download or read book Rossi's Principles of Transfusion Medicine written by Toby L. Simon and published by John Wiley & Sons. This book was released on 2016-03-15 with total page 760 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rossi's Principles of Transfusion Medicine is the most comprehensive and practical reference on transfusion science and medicine available Led by a world class Editor team, including two past-presidents of AABB, a past- President of the American Board of Pathology and members of the FDA Blood Products Advisory Committee , and international contributor team Comprehensive reference resource, considered the gold standard in transfusion Covers current hot topics such as donor care – including the frequency of donation and management of iron deficiency/status), patient blood management, hemovigilance, cstem cell therapies, and global aspects of the organization of transfusion and transplant services New material on molecular immunohematology Companion website includes figures, full text and references
Download or read book Programme budget 2022–2023 written by and published by World Health Organization. This book was released on 2021-10-08 with total page 131 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Commercializing Successful Biomedical Technologies by : Shreefal S. Mehta
Download or read book Commercializing Successful Biomedical Technologies written by Shreefal S. Mehta and published by Cambridge University Press. This book was released on 2008-04-24 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This book guides the reader through the practical aspects of the commercialization process of drug, diagnostic and device biomedical technology including market analysis, product development, intellectual property and regulatory constraints. Key issues are highlighted at each stage in the process, and case studies are used to provide practical examples. The book will provide a sound road map for those involved in the biotechnology industry to effectively plan the commercialization of profitable regulated medical products. It will also be suitable for a capstone design course in engineering and biotechnology, providing the student with the business acumen skills involved in product development.
Book Synopsis WHO Expert Committee on Specifications for Pharmaceutical Preparations by :
Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by and published by World Health Organization. This book was released on 2021-04-26 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. Standards are developed by the Expert Committee through worldwide consultation and an international consensus-building process. The following new guidance texts were adopted and recommended for use: Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations; Points to consider when including Health Based Exposure Limits (HBELs) in cleaning validation; Good manufacturing practices: water for pharmaceutical use; Guideline on data integrity; WHO/United Nations Population Fund recommendations for condom storage and shipping temperatures; WHO/United Nations Population Fund guidance on testing of male latex condoms; WHO/United Nations Population Fund guidance on conducting post-market surveillance of condoms; WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce; Good reliance practices in the regulation of medical products: high-level principles and considerations; and Good regulatory practices in the regulations of medical products. All of the above are included in this report and recommended for implementation.
Book Synopsis Chronological Document Listing, 1936-1976 by : United States. Food and Drug Administration
Download or read book Chronological Document Listing, 1936-1976 written by United States. Food and Drug Administration and published by . This book was released on 1977 with total page 546 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Guidance on implementation of a quality system in blood establishments by : World Health Organization
Download or read book Guidance on implementation of a quality system in blood establishments written by World Health Organization and published by World Health Organization. This book was released on 2024-02-23 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt:
