Download or read book The Rules Governing Medicinal Products in the European Community Good manufacturing practice for medicinal products written by Commission of the European Communities and published by Bernan Press(PA). This book was released on 1991 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 1993 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Rules Governing Medicinal Products in the European Community Veterinary medicinal products written by and published by . This book was released on 1989 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt: EEC regulations for the marketing, production, and distribution of pharmaceutical products to safeguard public health. Also includes the controls on manufacturing and labeling of drugs.

Download or read book The Rules Governing Medicinal Products in the European Community written by and published by . This book was released on 1989 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Rules Governing Medicinal Products in the European Community Notice to applicants for marketing authorizations for medicinal products for human use in the Member States of the European Community written by and published by . This book was released on 1989 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: EEC regulations for the marketing, production, and distribution of pharmaceutical products to safeguard public health. Also includes the controls on manufacturing and labeling of drugs.

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 Notice to applicants for marketing authorizations for medicinal products for human use in the member states of the European Community written by Commission of the European Communities and published by . This book was released on 1989 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt: EEC regulations for the marketing, production, and distribution of pharmaceutical products to safeguard public health. Also includes the controls on manufacturing and labeling of drugs.

Download or read book The Rules Governing Medicinal Products in the European Community The rules governing medicinal products for human use in the European Community written by and published by . This book was released on 1989 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: EEC regulations for the marketing, production, and distribution of pharmaceutical products to safeguard public health. Also includes the controls on manufacturing and labeling of drugs.

Download or read book The Rules Governing Medicinal Products in the European Union written by Commission of the European Communities and published by Bernan Press(PA). This book was released on 1998 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide is presented in chapters, each headed by a principle of GMP, outlining the Quality Assurance objectives of that chapter.

Download or read book The Rules Governing Medicinal Products in the European Union written by and published by . This book was released on 1998 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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.

Download or read book EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP written by Orlando Lopez and published by CRC Press. This book was released on 2015-04-06 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is

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 The Pocket Guide to the EU Directives for Clinical Research written by Julie Meeson and published by Inst of Clinical Research. This book was released on 2009 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book EU Food Law written by K Goodburn and published by Elsevier. This book was released on 2001-06-14 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: Given its fragmented development, EU food law can be seen as both complex and confusing. With its distinguished team of contributors, EU food law highlights the key issues so those non-specialists can understand the legislation and what it means for them. It is designed to help readers ask the right questions when developing and marketing products in the European Union, and to provide answers to those questions.The book begins with an overview of the development of EU food law, and then describes the main institutions involved in framing food legislation and the legislative process. This discussion is designed to provide a context for the chapters on specific aspects of EU food law that follow. Part one there are a series of chapters on legislation controlling food safety, ranging from the way food products are manufactured (hygiene and the control of contaminants) to food composition and packaging (additives and food contact materials). Part two considers how EU food law ensures that consumers are properly informed about the food products they buy. There are chapters on labelling, nutrition information, the increasingly important area of health claims, and the handling of foods for particular nutritional purposes. Part three of the book contains two case studies illustrating how these various strands of EU food law impact in practice on a particular food product, looking at both an established food ingredient and the emerging area of functional foods.EU food law provides an authoritative introduction and guide to a complex subject. It will be widely welcomed by all those designing food products for and selling food products in the European Union.

Download or read book Stephens Detection and Evaluation of Adverse Drug Reactions written by John Talbot and published by John Wiley & Sons. This book was released on 2011-10-28 with total page 751 pages. Available in PDF, EPUB and Kindle. Book excerpt: The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal products. Stephens' Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia. Praise for previous editions "This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work.” - from a review in E-STREAMS "...a key text in the area of pharmacovigilance...extensively referenced and well-written...a valuable resource..." - from a review in The Pharmaceutical Journal

Download or read book Handbook of Nuclear Medicine and Molecular Imaging for Physicists written by Michael Ljungberg and published by CRC Press. This book was released on 2022-03-18 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: This state-of-the-art handbook, the third and final in a series that provides medical physicists with a comprehensive overview into the field of nuclear medicine, focuses on highlighting the production and application of radiopharmaceuticals. With this, the book also describes the chemical composition of these compounds, as well as some of the main clinical applications where radiopharmaceuticals may be used. Following an introduction to the field of radiopharmacy, three chapters in this book are dedicated towards in-depth descriptions of common radionuclides and radiopharmaceuticals used during diagnostic studies utilizing planar/Single Photon Emission Computed Tomography (SPECT) imaging, in addition to during Positron Emission Tomography (PET) imaging, and, finally, radiotherapy. These chapters are followed by those describing procedures relating to quality control and manufacturing (good manufacturing practices) also encompassing aspects such as environmental compliance. Furthermore, this volume illustrates how facilities handling these chemicals should be designed to comply with set regulations. Like many pharmaceuticals, the development of radiopharmaceuticals relies heavily on the use of mouse models. Thus, the translation of radiopharmaceuticals (i.e., the process undertaken to assure that the functionality and safety of a newly developed drug is maintained also in a human context), is covered in a later chapter. This is followed by a chapter emphasising the importance of safe waste disposal and how to assure that these procedures meet the requirements set for the disposal of hazardous waste. Several chapters have also been dedicated towards describing various medical procedures utilizing clinical nuclear medicine as a tool for diagnostics and therapeutics. As physicists may be involved in clinical trials, a chapter describing the procedures and regulations associated with these types of studies is included. This is followed by a chapter focusing on patient safety and another on an imaging modality not based on ionizing radiation – ultrasound. Finally, the last chapter of this book discusses future perspectives of the field of nuclear medicine. This text will be an invaluable resource for libraries, institutions, and clinical and academic medical physicists searching for a complete account of what defines nuclear medicine. The most comprehensive reference available providing a state-of-the-art overview of the field of nuclear medicine Edited by a leader in the field, with contributions from a team of experienced medical physicists, chemists, engineers, scientists, and clinical medical personnel Includes the latest practical research in the field, in addition to explaining fundamental theory and the field's history