Rules And Guidance For Pharmaceutical 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 | : Peter Gotzsche |
Publisher | : CRC Press |
Total Pages | : 251 |
Release | : 2019-08-21 |
Genre | : Medical |
ISBN | : 1908911123 |
PRESCRIPTION DRUGS ARE THE THIRD LEADING CAUSE OF DEATH AFTER HEART DISEASE AND CANCER. In his latest ground-breaking book, Peter C Gotzsche exposes the pharmaceutical industries and their charade of fraudulent behaviour, both in research and marketing where the morally repugnant disregard for human lives is the norm. He convincingly draws close co
Author | : Mindy J. Allport-Settle |
Publisher | : Pharmalogika |
Total Pages | : 686 |
Release | : 2009-12 |
Genre | : Law |
ISBN | : 9780982147603 |
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.
Author | : United States. Federal Trade Commission. Bureau of Consumer Protection |
Publisher | : |
Total Pages | : 32 |
Release | : 1998 |
Genre | : Advertising |
ISBN | : |
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 | : Ben Goldacre |
Publisher | : Farrar, Straus and Giroux |
Total Pages | : 449 |
Release | : 2013-02-05 |
Genre | : Business & Economics |
ISBN | : 0374710171 |
We like to imagine that medicine is based on evidence and the results of fair testing and clinical trials. In reality, those tests and trials are often profoundly flawed. We like to imagine that doctors who write prescriptions for everything from antidepressants to cancer drugs to heart medication are familiar with the research literature about a drug, when in reality much of the research is hidden from them by drug companies. We like to imagine that doctors are impartially educated, when in reality much of their education is funded by the pharmaceutical industry. We like to imagine that regulators have some code of ethics and let only effective drugs onto the market, when in reality they approve useless drugs, with data on side effects casually withheld from doctors and patients. All these problems have been shielded from public scrutiny because they're too complex to capture in a sound bite. But Ben Goldacre shows that the true scale of this murderous disaster fully reveals itself only when the details are untangled. He believes we should all be able to understand precisely how data manipulation works and how research misconduct in the medical industry affects us on a global scale. With Goldacre's characteristic flair and a forensic attention to detail, Bad Pharma reveals a shockingly broken system and calls for regulation. This is the pharmaceutical industry as it has never been seen before.
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 | : 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 | : 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