Good Manufacturing Practice (GMP) Guidelines PDF Download
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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: 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: Scott L. Greer
Publisher: World Health Organization
ISBN: 9289050438
Category : Law
Languages : en
Pages : 191
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Book Description
Civil Society Organizations (CSOs) can make a vital contribution to public health and health systems but harnessing their potential is complex in a Europe where government-CSO relations vary so profoundly. This study is intended to outline some of the challenges and assist policy-makers in furthering their understanding of the part CSOs can play in tandem and alongside government. To this end it analyses existing evidence and draws on a set of seven thematic chapters and six mini case studies. They examine experiences from Austria Bosnia-Herzegovina Belgium Cyprus Finland Germany Malta the Netherlands Poland the Russian Federation Slovenia Turkey and the European Union and make use of a single assessment framework to understand the diverse contexts in which CSOs operate. The evidence shows that CSOs are ubiquitous varied and beneficial and the topics covered in this study reflect such diversity of aims and means: anti-tobacco advocacy food banks refugee health HIV/AIDS prevention and cure and social partnership. CSOs make a substantial contribution to public health and health systems with regards to policy development service delivery and governance. This includes evidence provision advocacy mobilization consensus building provision of medical services and of services related to the social determinants of health standard setting self-regulation and fostering social partnership. However in order to engage successfully with CSOs governments do need to make use of adequate tools and create contexts conducive to collaboration. To guide policy-makers working with CSOs through such complications and help avoid some potential pitfalls the book outlines a practical framework for such collaboration. This suggests identifying key CSOs in a given area; clarifying why there should be engagement with civil society; being realistic as to what CSOs can or will achieve; and an understanding of how CSOs can be helped to deliver.
