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Licensing Of Drug Product For European Union
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Book Synopsis Pharmaceutical Product Licensing by : Brian R. Matthews
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.
Book Synopsis Licensing of Drug product for European Union by : Sandeep Narayan Patil, PMP
Download or read book Licensing of Drug product for European Union written by Sandeep Narayan Patil, PMP and published by Notion Press. This book was released on 2021-05-25 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the second book in the series of three. These three books will be based upon the idea to tailor PMI’s Project Management methodologies to the typical pharmaceutical projects. This book mainly discusses launch of drug products in EU market which are manufactured in countries like India or china by supplier manufacturer. It is specially designed for Project Managers, team members and pharmacy students. Format of book is purposely kept simple. This book includes various useful flow charts and templates that can be used during the project life cycle. Information provided in this book is obtained from highly authentic sources, and links of data sources is provided for reference. Surely this is the kind of book every pharmaceutical personnel will want to be on their shelf.
Book Synopsis Pharmaceutical Product Licensing by : A. C. Cartwright
Download or read book Pharmaceutical Product Licensing written by A. C. Cartwright and published by CRC Press. This book was released on 1991-05-31 with total page 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.
Book Synopsis Medical Product Regulatory Affairs by : John J. Tobin
Download or read book Medical Product Regulatory Affairs written by John J. Tobin and published by John Wiley & Sons. This book was released on 2023-08-29 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical Product Regulatory Affairs Hands-on guide through the jungle of medical regulatory affairs for every professional involved in bringing new products to market Based on a module prepared by the authors for an MSc course offered by the University of Limerick, Ireland, Medical Product Regulatory Affairs is a comprehensive and practical guide on how pharmaceutical and medical devices are regulated within the major global markets. The Second Edition builds on the success of the first with an even wider scope and full coverage of new EU regulations on the safe use of medical devices. Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and regulation in the USA. Other topics dealt with include CDER, CBER and marketing and manufacturing licenses, the ICH process and Good Laboratory/Clinical/ Manufacturing Practices. Medical Product Regulatory Affairs includes information on: Aims and structure of regulation, covering purpose and principles of regulation, national and EU legislative processes, and pharmacopeia Regulatory strategy, covering product development and manufacturing, market vigilance, quality assurance systems, personnel, and documentation Drug discovery and development, covering prescription status, physical properties, therapeutic use, and drug discovery, development, and delivery Non-clinical studies, covering non-clinical study objectives and timing, pharmacological and pharmacodynamic studies, and bioavailability and bioequivalence Clinical trials, covering trial protocol, monitoring of trials, trial master files, and FDA communications The wide coverage of different product types and the main global markets makes Medical Product Regulatory Affairs ideal for training courses on regulatory affairs in academia and industry. It is also a valuable reference for pharmacologists, bioengineers, pharma engineers, and students in pharmacy to familiarize themselves with the topic.
Book Synopsis Medical Devices and the Public's Health by : Institute of Medicine
Download or read book Medical Devices and the Public's Health written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-25 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
Book Synopsis Assuring the Quality of Health Care in the European Union by : Helena Legido-Quigley
Download or read book Assuring the Quality of Health Care in the European Union written by Helena Legido-Quigley and published by World Health Organization. This book was released on 2008 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis A review of UK health research funding by : David Sir Cooksey
Download or read book A review of UK health research funding written by David Sir Cooksey and published by The Stationery Office. This book was released on 2006-12-06 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Review sets out to propose a structure for the funding arrangements for the whole spectrum of health research, with the objective of obtaining the maximum benefit from research success and, where possible, eliminating duplication of effort. The Review found, however, that the UK is at risk of failing to reap the full economic, health and social benefits that the UK's public investment in health research should generate. There is no overarching UK health research strategy to ensure UK health priorities are considered through all types of research and there are two key gaps in the translation of health research: (i) translating ideas from basic and clinical research into the development of new products and approaches to treatment of disease and illness; (ii) implementing those new products and approaches into clinical practice.The Review also found that the wider funding arrangements for supporting translation of ideas from conception to practice could be more coherent or comprehensive and, where arrangements exist, they do not function well. The Review identified cultural, institutional and financial barriers to translating research into practice in the publicly funded research arena. But it also found that, in the private sector, the pharmaceuticals industry is facing increasing challenges in translating research into health and economic benefit. The Review has sought to make recommendations that will increase the translation of R&D into health and economic benefit for the UK, both in the public and private sectors. The Review recommends that the Government should seek to achieve better coordination of health research and more coherent funding arrangements to support translation by establishing an Office for Strategic Coordination of Health Research (OSCHR).
Book Synopsis Evaluating Pharmaceuticals for Health Policy and Reimbursement by : Nick Freemantle
Download or read book Evaluating Pharmaceuticals for Health Policy and Reimbursement written by Nick Freemantle and published by John Wiley & Sons. This book was released on 2008-04-15 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: “The challenge in all settings is to make the difficultdecisions in a way that is defensible, justifiable, ethical, andequitable” So write Nick Freemantle and Suzanne Hill in their introductionto this important discussion on decision making in thereimbursement of pharmaceuticals. Based around a programmesupported by the World Health Organization, chapters by leadingacademics involved in the research tackle such major issues asinternational pharmaceutical policy, tensions in licensingpolicies, priority setting, and relationships between thestakeholders. Chapters include Development of marketing authorisation procedures forpharmaceuticals Interpreting clinical evidence International pharmaceutical policy: health creation or wealthcreation? Development of fourth hurdle policies around the world Economic modelling in drug reimbursement Priority setting in health care: matching decision criteriawith policy objectives Tensions in licensing and reimbursement decisions: case ofriluzole for amytrophic lateral sclerosis Relationship between stakeholders: managing the war ofwords Medicine and the media: good information or misleadinghype? How to promote quality use of cost-effective medicines Using economic evaluation to inform health policy andreimbursement: making it happen and making it sustainable Pricing of pharmaceuticals Evaluating pharmaceuticals for health policy in low and middleincome country settings. Besides the controversial issues there is a wealth of practicalinformation including economic modelling and the experiences fromthe WHO programme, providing readers with workable examples. Thisis essential reading for clinical researchers in pharmaceuticalsand policy makers everywhere.
Book Synopsis Good Manufacturing Practice (GMP) Guidelines by : Mindy J. Allport-Settle
Download or read book Good Manufacturing Practice (GMP) Guidelines written by Mindy J. Allport-Settle and published by Pharmalogika. This book was released on 2009-12 with total page 686 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title combines all of the human and veterinary Regulations, Directives and guidance for medicinal products used by the pharmaceutical industry as their main source when manufacturing and distributing medicinal products in the European Union.
Book Synopsis Drug Delivery Trends by : Ranjita Shegokar
Download or read book Drug Delivery Trends written by Ranjita Shegokar and published by Elsevier. This book was released on 2020-03-01 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Delivery Trends examines a drift in the pharmaceutical field across the wide range of dosage forms, drug delivery systems (micro and nanoparticulate), at the regulatory front and on new types of therapies in the market. This volume additionally covers the challenges on drug delivery systems in terms of preclinical and current ways of determining quality and the options to solve the challenges associated with this. Most small-medium scale industries and academics struggle with initial regulatory challenges so a detailed discussion on regulatory trend covers the necessary basic understanding of regulatory procedures and provides the required guidance. The series Expectations and Realities of Multifunctional Drug Delivery Systems examines the fabrication, optimization, biological aspects, regulatory and clinical success of wide range of drug delivery carriers. This series reviews multifunctionality and applications of drug delivery systems, industrial trends, regulatory challenges and in vivo success stories. Throughout the volumes discussions on diverse aspects of drug delivery carriers, such as clinical, engineering, and regulatory, facilitate insight sharing across expertise area and form a link for collaborations between industry-academic scientists and clinical researchers. Expectations and Realities of Multifunctional Drug Delivery Systems connects formulation scientists, regulatory experts, engineers, clinical experts and regulatory stake holders. The wide scope of the book ensures it as a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about drug delivery systems. Encompasses trends in drug delivery systems and selected dosage forms Illustrates regulatory, preclinical and quality principles Contains in-depth investigation of upcoming types of drug delivery systems
Book Synopsis Regulatory Affairs in the Pharmaceutical Industry by : Javed Ali
Download or read book Regulatory Affairs in the Pharmaceutical Industry written by Javed Ali and published by Academic Press. This book was released on 2021-11-14 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Affairs in the Pharmaceutical Industry is a comprehensive reference that compiles all the information available pertaining to regulatory procedures currently followed by the pharmaceutical industry. Designed to impart advanced knowledge and skills required to learn the various concepts of regulatory affairs, the content covers new drugs, generic drugs and their development, regulatory filings in different countries, different phases of clinical trials, and the submission of regulatory documents like IND (Investigational New Drug), NDA (New Drug Application) and ANDA (Abbreviated New Drug Application). Chapters cover documentation in the pharmaceutical industry, generic drug development, code of Federal Regulation (CFR), the ANDA regulatory approval process, the process and documentation for US registration of foreign drugs, the regulation of combination products and medical devices, the CTD and ECTD formats, and much more. Updated reference on drug approval processes in key global markets Provides comprehensive coverage of concepts and regulatory affairs Presents a concise compilation of the regulatory requirements of different countries Introduces the fundamentals of manufacturing controls and their regulatory importance
Book Synopsis Diagnostic Immunohistochemistry by : David J. Dabbs
Download or read book Diagnostic Immunohistochemistry written by David J. Dabbs and published by Churchill Livingstone. This book was released on 2006 with total page 858 pages. Available in PDF, EPUB and Kindle. Book excerpt: Offers current information and guidance on immunohistochemical diagnoses in surgical pathology and cytopathology. The book is organized in a consistent format of organ systems, specifically designed to target diagnostic dilemmas in surgical pathology. Each chapter features an introduction and a systematic approach to the diagnostic entities of that organ system. Provides a reference for pathologists practicing diagnostic surgical pathology and cytopathology. Structured in the organ-system approach to tumor pathology, with each chapter capable of standing alone. Extensive references and full-color illustrations are included.
Book Synopsis Regulatory Toxicology in the European Union by : Tim Marrs
Download or read book Regulatory Toxicology in the European Union written by Tim Marrs and published by Royal Society of Chemistry. This book was released on 2018-02-26 with total page 638 pages. Available in PDF, EPUB and Kindle. Book excerpt: Consumer and environmental protection depend on the careful regulation of all classes of chemicals. Toxicology is the key science used to evaluate safety and so underpins regulatory decisions on chemicals. With the growing body of EU legislation involved in chemical regulation, there is a concomitant need to understand the toxicological principles underlying safety assessments. Regulatory Toxicology in the European Union is the first book to cover regulatory toxicology specifically in Europe. It addresses the need for a wider understanding of the principles of regulatory toxicology and their application and presents the relationship between toxicology and legislative processes in regulating chemical commodities across Europe. This title has a broad scope, covering historical and current chemical regulation in Europe, the role of European agencies and institutions, and also the use of toxicology data for important classes of chemicals, including human and veterinary medicines, animal feed and food additives, biocides, pesticides and nanomaterials. This book is therefore extremely pertinent and timely in the toxicology field at present. This book is an essential reference for regulatory authorities, industrialists, academics, undergraduates and postgraduates working within safety and hazards, toxicology, the biological sciences, and the medicinal and pharmaceutical sciences across the European Union.
Book Synopsis Improving Healthcare Quality in Europe Characteristics, Effectiveness and Implementation of Different Strategies by : OECD
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 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.
Book Synopsis ICH Quality Guidelines by : Andrew Teasdale
Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309464102 Total Pages :215 pages Book Rating :4.3/5 (94 download)
Book Synopsis Reducing the Threat of Improvised Explosive Device Attacks by Restricting Access to Explosive Precursor Chemicals by : National Academies of Sciences, Engineering, and Medicine
Download or read book Reducing the Threat of Improvised Explosive Device Attacks by Restricting Access to Explosive Precursor Chemicals written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-04-19 with total page 215 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improvised explosive devices (IEDs) are a type of unconventional explosive weapon that can be deployed in a variety of ways, and can cause loss of life, injury, and property damage in both military and civilian environments. Terrorists, violent extremists, and criminals often choose IEDs because the ingredients, components, and instructions required to make IEDs are highly accessible. In many cases, precursor chemicals enable this criminal use of IEDs because they are used in the manufacture of homemade explosives (HMEs), which are often used as a component of IEDs. Many precursor chemicals are frequently used in industrial manufacturing and may be available as commercial products for personal use. Guides for making HMEs and instructions for constructing IEDs are widely available and can be easily found on the internet. Other countries restrict access to precursor chemicals in an effort to reduce the opportunity for HMEs to be used in IEDs. Although IED attacks have been less frequent in the United States than in other countries, IEDs remain a persistent domestic threat. Restricting access to precursor chemicals might contribute to reducing the threat of IED attacks and in turn prevent potentially devastating bombings, save lives, and reduce financial impacts. Reducing the Threat of Improvised Explosive Device Attacks by Restricting Access to Explosive Precursor Chemicals prioritizes precursor chemicals that can be used to make HMEs and analyzes the movement of those chemicals through United States commercial supply chains and identifies potential vulnerabilities. This report examines current United States and international regulation of the chemicals, and compares the economic, security, and other tradeoffs among potential control strategies.
Book Synopsis Pharmacy Law and Practice by : Jon Merrills
Download or read book Pharmacy Law and Practice written by Jon Merrills and published by Academic Press. This book was released on 2013-04-19 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fifth edition of Pharmacy Law and Practice provides a straightforward and useable guide for students, practitioners, academics and others interested in pharmacy law and practice in the United Kingdom. This multi-dimensional book includes discussions of socio-political influences on legal developments to provide greater insight to the reader. It clearly sets out the background to regulatory issues together with simple and practical statements of what a pharmacist has to do to obey the law. As in previous editions, this book discusses topics thematically rather than by statute. It is a unique and reader-friendly guide that boils down the complex or difficult language of the law, describes the reasons behind it, and illustrates the application to pharmacy practice. Thoroughly updated to reflect regulatory and legal developments in areas including employment law, online transactions and internet pharmacies, non-medical prescribing and more Takes an intuitive, problem-solving approach and discusses topics thematically rather than by statute to show how all of the larger pieces fit together The electronic version of this book contains valuable links to provide readers with the most current information in a rapidly changing subject area
