Download or read book Pharmacetical Applications in the European Union written by Cheng Yee Lowe and published by CRC Press. This book was released on 1998-02-28 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by an expert with twenty years' experience in regulatory affairs in a number of multi-national companies, this book guides readers through the legislative minefield of registering medicinal products in the European Union. Taking a step-by-step approach, the book demystifies all of the regulatory requirements and gives a clear understanding of how to achieve compliance. The author gathers all the relevant requirements, puts them into context, and provides regulatory information in an easily accessible format. Headings, subheadings, and key points organized in tabular format make the information easy for readers to find and the book easy for readers to use.
Download or read book The Rules Governing Medicinal Products in the European Union written by European Commission and published by Bernan Press(PA). This book was released on 1998 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: A series governing medicinal products in the European Union. There are three volumes (including this one) covering products for human use, three covering veterinary medicinal products and one covering both. The volumes consist of legislation, notice to applicants, guidelines and good practice.
Download or read book The Rules Governing Medicinal Products in the European Community written by Commission of the European Communities and published by . This book was released on 1991 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1992 with total page 666 pages. Available in PDF, EPUB and Kindle. Book excerpt: First multi-year cumulation covers six years: 1965-70.
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.
Download or read book The European Marketplace written by James Hogan and published by Springer. This book was released on 1990-11-19 with total page 565 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Download or read book International Pharmaceutical Product Registration written by Anthony C. Cartwright and published by CRC Press. This book was released on 2016-04-19 with total page 804 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou
Download or read book Quality assurance of pharmaceuticals a compendium of guidelines and related materials Volume 2 Good manufacturing practices and inspection written by World Health Organization and published by World Health Organization. This book was released on 2024-01-31 with total page 1354 pages. Available in PDF, EPUB and Kindle. Book excerpt: The GMP Compendium for Medical Products is a valuable resource for manufacturers, regulators, and other stakeholders involved in producing and distributing medical products. It covers various topics, from quality management systems to personnel hygiene, equipment validation, and complaint handling. The guidance provided is based on the latest scientific and technical knowledge and considers the evolving regulatory landscape and the challenges faced by the industry.
Download or read book National Library of Medicine Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1992 with total page 1184 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Vaccine Adjuvants written by Derek T. O’Hagan and published by Springer Science & Business Media. This book was released on 2008-02-02 with total page 343 pages. Available in PDF, EPUB and Kindle. Book excerpt: Derek T. O'Hagan and a team of expert vaccinologists and pharmacologists thoroughly describe the preparation, characterization, and evaluation of a wide range of alternative vaccine adjuvants for use in preclinical studies. Each chapter carefully reviews a single adjuvant, and suggests why a specific adjuvant might be preferred for a given antigen, depending on what type of immune response is desired. Alternate adjuvant choices are also presented so that researchers can choose those most efficacious for their specific purpose. Comprehensive and highly practical, Vaccine Adjuvants: Preparation Methods and Research Protocols provides an effective guide to making and using vaccine adjuvants. By closely following directions from the book, today's researchers will be able optimally to induce specific immune responses against different types of antigens and to selectively manipulate the immune response in a favorable way.
Download or read book Pharmaceutical Product Licensing written by Brian R. Matthews and published by CRC Press. This book was released on 1991-05-31 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides a systematic account of the major technical, administrative and legal requirements for registering a product in any of the national markets within the EEC, using the existing procedures, with guidance as to how these procedures are likely to change after 1992.
Download or read book Bioseparations of Proteins written by Ajit Sadana and published by Elsevier. This book was released on 1997-11-27 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers the fundamentals of protein inactivation during bioseparation and the effect on protein processing. Bioseparation of Proteins is unique because it provides a background of the bioseparation processes, and it is the first book available to emphasize the influence of the different bioseparation processes on protein inactivation.Bioseparation of Proteins covers the extent, mechanisms of, and control of protein inactivation during these processes along with the subsequent and essential validation of these processes. The book focuses on the avoidance of protein (biologicalproduct) inactivation at each step in a bioprocess. It compares protein inactivation exhibited during the different bioseparation processes by different workers and provides a valuable framework for workers in different areas interested in bioseparations.Topics include separation and detection methods; estimates of protein inactivation and an analysis of this problem for different separation processes; strategies for avoiding inactivation; the molecular basis of surface activity and protein adsorption,process monitoring, and product validation techniques; and the economics of various bioseparation processes and quality control procedures.Key Features* Protein inactivation and other aspects of biological stability are critical to an effective bioseparation process; This book is a detailed and critical review of the available literature in an area that is essential to the effectiveness, validation, and economics of bioseparation processes for drugs and other biological products; Conveniently assembled under one cover, the survey of the literature and resulting perspective will greatly assist engineers and chemists in designingand improving their own processes; Key features of the text include:* detailed data on biological stability under various bioseparation conditions* extensive case studies from the literature on separation processes, validation, and economics* simplified analysis of protein refolding and inactivation mechanisms* consideration of adsorption theories and the effect of heterogeneity* coverage of both classical and novel bioseparation techniques, including chromatographic procedures
Download or read book Good Clinical Practice eRegs Guides For Your Reference Book 4 written by eRegs & Guides and published by eregs & guides. This book was released on 2013-11-22 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Clinical Practice For Your Reference - Book 4 ICH - Clinical Safety E1 - E2F ICH-E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions ICH-E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting ICH-E2B(R2) Clinical Safety Data Management : Data Elements for Transmission of Individual Case Safety Reports ICH-E2C(R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs ICH-E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting ICH-E2E Pharmacovigilance Planning ICH-E2F Development Safety Update Report Samples of DSURS European Directive 2001/20/EC European Directive 2005/28/EC
Download or read book Blood Plasma and Plasma Proteins written by José Luis Valverde and published by IOS Press. This book was released on 2006 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: Labile blood products and plasma-derived products are very sensitive form a social viewpoint. Along with the challenges faced by all medicinal products there is an added challenge due to the lack of raw material and the social problems with regards to their acquisition. Obtaining them depends on blood and plasma donations, which are insufficient. Europeans as a whole fail to even cover 40 % of their needs in plasma for fractionation. The aspiration that all donations shall be voluntary, free and unpaid, is an altruistic objective, which reality, unfortunately, contradicts every day. Governments and all social Agencies should promote to the maximum its actions in order to achieve the greatest number of donation each day. Even from a humanitarian or ethical viewpoint nobody can deny a possible donor accepting incentives. This incentive discussion, plus the concept of self-sufficiency of countries and more are discussed in this volume.
Download or read book Dictionary of Pharmaceutical Medicine written by Gerhard Nahler and published by Springer Science & Business Media. This book was released on 2013-06-29 with total page 186 pages. Available in PDF, EPUB and Kindle. Book excerpt: This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities.
