European Union Pharmaceutical Industry Handbook
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European Union Pharmaceutical Industry Handbook
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Author : USA International Business Publications
language : en
Publisher:
Release Date : 2006-01-01
European Union Pharmaceutical Industry Handbook written by USA International Business Publications and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-01-01 with Business & Economics categories.
European Union Pharmaceutical Industry Handbook
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Author : IBP USA Staff
language : en
Publisher:
Release Date : 2009-03-20
European Union Pharmaceutical Industry Handbook written by IBP USA Staff and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-03-20 with Business & Economics categories.
European Union Pharmaceutical Industry Handbook
Good Quality Practice Gqp In Pharmaceutical Manufacturing A Handbook
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Author : Jordi Botet
language : en
Publisher: Bentham Science Publishers
Release Date : 2015-09-28
Good Quality Practice Gqp In Pharmaceutical Manufacturing A Handbook written by Jordi Botet and has been published by Bentham Science Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-09-28 with Medical categories.
Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.
Guide To Eu Pharmaceutical Regulatory Law
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Author : Sally Shorthose
language : en
Publisher: Kluwer Law International B.V.
Release Date : 2017-02-17
Guide To Eu Pharmaceutical Regulatory Law written by Sally Shorthose and has been published by Kluwer Law International B.V. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-17 with Law categories.
In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: - obtaining a marketing authorisation; - stages and standards for creating a product dossier; - clinical trials; - how and when an abridged procedure can be used; - criteria for conditional marketing authorisations; - generic products and ‘essential similarity’; - paediatric use and the requisite additional trials; - biologicals and ‘biosimilars’; - homeopathic and herbal medicines; - reporting procedures; - pharmacovigilance; - parallel trade; - relevant competition law and intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
The Certified Pharmaceutical Gmp Professional Handbook
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Author : Mark Allen Durivage
language : en
Publisher: Quality Press
Release Date : 2016-05-23
The Certified Pharmaceutical Gmp Professional Handbook written by Mark Allen Durivage and has been published by Quality Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-05-23 with Technology & Engineering categories.
The purpose of this handbook is to assist individuals for the Certified Pharmaceutical Good Manufacturing Practices Professional (CPGP) examination and provide a reference for the practitioner. The second edition reflects the Body of Knowledge which was updated in 2015. This edition has also incorporated additional information including updated references. The updates reflect the current trends and expectations of the evolving pharmaceutical industry driven by consumer expectations and regulatory oversight. This handbook covers compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, and combination devices, as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations.
Pharmacetical Applications In The European Union
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Author : Cheng Yee Lowe
language : en
Publisher: CRC Press
Release Date : 1998-02-28
Pharmacetical Applications In The European Union written by Cheng Yee Lowe and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998-02-28 with Technology & Engineering categories.
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.
The Handbook Of Basic Gmp Requirements
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Author : Karyn Noemi Santoro
language : en
Publisher:
Release Date : 2020-10-23
The Handbook Of Basic Gmp Requirements written by Karyn Noemi Santoro and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-10-23 with categories.
This Handbook of Basic GMP Requirements is a collection of official guidelines reported in the Eudralex website, Volume 4. Specifically, all nine chapters from Part I "Basic Requirements for Medicinal Products" are here reported.Since the pharmaceutical industry of the European Union maintains high standards of Quality Management in the development, manufacture and control of medicinal products, a regulated system is required to ensure that all medicinal products are assessed by a competent authority to ensure compliance with contemporary requirements of safety, quality and efficacy. Building a good quality system ensures not only that all products shipped around the European market are manufactured/ imported only by authorised manufacturers, but also that whose activities are regularly inspected by the competent authorities, using Quality Risk Management principles. Pharmaceutical industries must follow these guidelines and thanking to their persistent effort, they will be able to successfully manufacture a high quality, deliverable, stable medicine for human use and controlled according to quality standards appropriate to their intended use and as required by the marketing authorization.Good Manufacturing Practice guidelines aimed primarily at diminishing the risks inherent in any pharmaceutical production and not place the patients' health at risk due to inadequate safety, quality or efficacy.
Guide To Eu And Uk Pharmaceutical Regulatory Law
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Author : Sally Shorthose
language : en
Publisher: Kluwer Law International B.V.
Release Date : 2023-01-10
Guide To Eu And Uk Pharmaceutical Regulatory Law written by Sally Shorthose and has been published by Kluwer Law International B.V. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-01-10 with Law categories.
In the European Union (EU), its Member States and the United Kingdom (UK) post-Brexit, as elsewhere, the marketing of pharmaceuticals is subject to an ever more complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but also safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. Following a brief overview of how the exit from the EU by the UK currently affects the regulatory regime, as well as an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of the following twenty-one incisive chapters examines a particular process or subject. Among the many topics and issues covered from both an EU and UK perspective are the following: clinical trials; stages and standards for creating a product dossier; obtaining a marketing authorisation; how and when an abridged marketing authorisation procedure can be used; criteria for conditional marketing authorisations; generic products and ‘essential similarity’; paediatric use and the requisite additional trials; orphan medicinal products; biologicals and ‘biosimilars’; homeopathic, herbal and similar medicines; medical devices; pandemics, epidemics and vaccines; pharmacovigilance; parallel trade; advertising; and relevant competition law, intellectual property rights and data protection regulation. In addition, sample forms and URLs for the most important reference materials are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Medical Product Regulatory Affairs
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Author : John J. Tobin
language : en
Publisher: John Wiley & Sons
Release Date : 2023-08-29
Medical Product Regulatory Affairs written by John J. Tobin and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-08-29 with Science categories.
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.
European Union Pharmaceutical Legislation Handbook
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Author : USA International Business Publications
language : en
Publisher:
Release Date : 2006-01-01
European Union Pharmaceutical Legislation Handbook written by USA International Business Publications and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-01-01 with Business & Economics categories.