Rules and Guidance for Pharmaceutical Manufacturers and Distributors (Orange Guide) 2022
Author | : Medicines and Healthcare Products Regulatory Agency |
Publisher | : |
Total Pages | : 1140 |
Release | : 2022-03-07 |
Genre | : |
ISBN | : 9780857114396 |
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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 | : Mrs.Sage De Clerck |
Publisher | : International Monetary Fund |
Total Pages | : 470 |
Release | : 2015-03-10 |
Genre | : Business & Economics |
ISBN | : 1498379214 |
The 2007–09 international financial crisis underscored the importance of reliable and timely statistics on the general government and public sectors. Government finance statistics are a basis for fiscal analysis and they play a vital role in developing and monitoring sound fiscal programs and in conducting surveillance of economic policies. The Government Finance Statistics Manual 2014 represents a major step forward in clarifying the standards for compiling and presenting fiscal statistics and strengthens the worldwide effort to improve public sector reporting and transparency.
Author | : Ben Goldacre |
Publisher | : Macmillan |
Total Pages | : 479 |
Release | : 2014-04 |
Genre | : Business & Economics |
ISBN | : 0865478066 |
Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.
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 | : Thorsteinn Loftsson |
Publisher | : Academic Press |
Total Pages | : 170 |
Release | : 2014-01-25 |
Genre | : Medical |
ISBN | : 0124115624 |
Drug Stability for Pharmaceutical Scientists is a clear and easy-to-follow guide on drug degradation in pharmaceutical formulation. This book features valuable content on both aqueous and solid drug solutions, the stability of proteins and peptides, acid-base catalyzed and solvent catalyzed reactions, how drug formulation can influence drug stability, the influence of external factors on reaction rates and much more. Full of examples of real-life formulation problems and step-by-step calculations, this book is the ideal resource for graduate students, as well as scientists in the pharmaceutical and related industries. - Illustrates important theoretical concepts with numerous examples, figures, calculations, learning problems and questions for self-study and retention of material - Provides answers and explanations to test your knowledge - Enables you to better understand key concepts such as rate and order of reaction, reaction equilibrium, complex reaction mechanisms and more - Includes an in-depth discussion of both aqueous and solid drug solutions and contains the latest international regulatory requirements on drug stability
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 | : 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.