Author: Mindy J. Allport-Settle
Publisher: Pharmalogika
ISBN: 9780982147603
Category : Law
Languages : en
Pages : 686
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Book Description
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: European Commission
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 424
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Book Description
1.Quality guidelines - 2.Biotechnology guidelines - 3.Index.
Author: Commission of the European Communities
Publisher:
ISBN: 9789282820605
Category : Drugs
Languages : en
Pages : 196
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Book Description
Recoge: 1.Marketing authorisations - 2.Mutual recognition - 3.Community referral - 4.Centralised procedure - 5.Variations - 6.Community marketing authorisation - 7.General information.
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 164
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Book Description
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.
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 200
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Book Description
Author: Unión Europea
Publisher:
ISBN: 9789282824382
Category :
Languages : en
Pages : 248
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Book Description
Author: Commission of the European Communities
Publisher:
ISBN: 9789282692073
Category : Drugs
Languages : en
Pages : 402
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Book Description
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498635
Category : Medical
Languages : en
Pages : 169
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Book Description
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author: Commission of the European Communities
Publisher: Bernan Press(PA)
ISBN:
Category : Business & Economics
Languages : en
Pages : 196
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Book Description
Author: Helena Legido-Quigley
Publisher: World Health Organization
ISBN: 9289071931
Category : Medical
Languages : en
Pages : 242
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Book Description
People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
