Rules And Guidance For Pharmaceutical Manufacturers And Distributors 2014
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Author | : |
Publisher | : |
Total Pages | : 0 |
Release | : 2014 |
Genre | : Drugs |
ISBN | : 9780857111029 |
This publication, known as the "Orange Guide", has been an essential reference for those involved in the manufacture or distribution of medicines in Europe. The Orange Guide collates in one convenient and authoritative source European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. In the production and distribution of medicines for human use, compliance with Good Manufacturing Practice and Good Distribution Practice is a necessity. Changes to this particular edition include: detailed changes to the EU guide to good manufacturing practice; detailed revisions to the EU Directive on medicinal products for human use; the new Directive on the Principles and Guidelines on Good Manufacturing Practice of Medicinal Products for Human Use. The document is compiled by the Inspection and Standards Division of the Medicines and Healthcare products Regulatory Agency.
Author | : Medicines and Healthcare Products Regulatory Agency |
Publisher | : |
Total Pages | : 1140 |
Release | : 2022-03-07 |
Genre | : |
ISBN | : 9780857114396 |
Author | : Mrha |
Publisher | : |
Total Pages | : 0 |
Release | : 2014-01-06 |
Genre | : Pharmaceutical industry |
ISBN | : 9780857111036 |
An essential reference work for all those involved in the distribution of medicines in Europe. It reproduces relevant parts of Rules and Guidance for Pharmaceutical Manufacturers and Distributors (commonly known as the "Orange Guide") specific to wholesale supply and distribution of medicines for human use. It is compiled by the UK drug regulatory body, the MHRA, and contains official EU guidance on good distribution practice and wholesale distribution along with relevant information on EU and UK legislation. It brings together the main pharmaceutical regulations, directives and guidance which manufacturers and wholesalers are expected to follow when distributing medicinal products within Europe.
Author | : United States. Federal Trade Commission. Bureau of Consumer Protection |
Publisher | : |
Total Pages | : 32 |
Release | : 1998 |
Genre | : Advertising |
ISBN | : |
Author | : National Academies of Sciences, Engineering, and Medicine |
Publisher | : National Academies Press |
Total Pages | : 235 |
Release | : 2018-03-01 |
Genre | : Medical |
ISBN | : 0309468086 |
Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Author | : National Academies of Sciences, Engineering, and Medicine |
Publisher | : National Academies Press |
Total Pages | : 483 |
Release | : 2017-09-28 |
Genre | : Medical |
ISBN | : 0309459575 |
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Author | : Alison M. Beaney |
Publisher | : |
Total Pages | : 0 |
Release | : 2016 |
Genre | : Asepsis and antisepsis |
ISBN | : 9780857113078 |
Quality Assurance of Aseptic Preparation Services Standards Handbook (also known as the Yellow Guide) provides standards for unlicensed aseptic preparation in the UK, as well as practical information to aid implementation of the standards. The handbook delivers essential standards in a practical way and in a format that will be useful for pharmacy management, staff working in aseptic preparation units and those whose role it is to audit the services. The accompanying support resources help with understanding the complexities of relevant topics including microbiology, radiopharmaceuticals, advanced therapy medicinal products, technical (quality) agreements and capacity planning. All the standards have been revised and updated for this 5th edition. The text is produced on behalf of the Royal Pharmaceutical Society (RPS) and the NHS Pharmaceutical Quality Assurance Committee. New in this edition: Replaces the 4th edition standards and forms the basis for an ongoing audit program in the NHS Many new and revised standards Greater emphasis on Pharmaceutical Quality Systems; the responsibilities of pharmacy management, Chief Pharmacists (or equivalent), has been expanded in line with developments in Good Manufacturing Practice Reformatted into 2 parts: standards and support resources. This is a new collaboration between the RPS and NHS. Since the previous edition the RPS has become the professional body for pharmacists and pharmaceutical scientists. RPS launched these standards as part of a library of professional standards and a programme of work to create standards for all areas of pharmacy. The Handbook is essential for pharmacists, hospital pharmacy management and technical services teams, and auditors of unlicensed NHS hospital pharmacy aseptic preparation services in the UK, pharmacists and regulators. The text is used to inform standards used in several other countries.
Author | : Royal Pharmaceutical Society of Great Britain |
Publisher | : Pharmaceutical Press |
Total Pages | : 212 |
Release | : 2015-07-18 |
Genre | : Medical |
ISBN | : 0857112406 |
The Royal Pharmaceutical Society's established professional guide for pharmacists.
Author | : Graham Dukes |
Publisher | : Edward Elgar Publishing |
Total Pages | : 419 |
Release | : 2014-06-27 |
Genre | : Business & Economics |
ISBN | : 1783471107 |
The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the pr
Author | : Thirumurthy Velpandian |
Publisher | : Springer |
Total Pages | : 541 |
Release | : 2016-02-29 |
Genre | : Medical |
ISBN | : 3319254987 |
This book comprises an integrated review of ocular therapeutics across all relevant fields. It addresses the real-world requirements of ophthalmologists, pharmacists and optometrists, as observed through working alongside these practitioners for two decades. Knowledge surrounding agents used in ophthalmic practice has, historically, been scattered. The book facilitates understanding of ocular drug therapy by compiling all key aspects of the pharmacology, toxicology, pharmaceutical science, ocular biochemistry and cell biology of these agents. Chapters detail drug transfer across barriers, systemic toxicity of topically applied drugs, autonomic drugs used for diagnostics, as well as anti-inflammatory, antiallergic, glaucoma and antimicrobial therapies, and avenues for the development of new ocular drugs. Applications of extemporaneously prepared formulations are described to inform day-to-day clinical practice. The use of mucoadhesive polymers in tear substitutes, ocular drug delivery systems, stem cell therapy, pharmacogenomics and antiangiogenic ocular chemotherapy are also explored. The book also provides insights from drugs of herbal origin, and a historical perspective on drugs for ocular use. Practicing and resident ophthalmologists, optometrists, pharmacists, nursing professionals, scholars in ocular drug research and students will equally benefit from this comprehensive guide.