The Rules Governing Medicinal Products in the European Union PDF Download
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Author: European Commission
Publisher: Bernan Press(PA)
ISBN: 9789282820322
Category : Medical
Languages : en
Pages : 304
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Book Description
A series governing medicinal products in the European Union. There are three volumes (including this one) covering products for human use, three covering veterinary medicinal products and one covering both. The volumes consist of legislation, notice to applicants, guidelines and good practice.
Author: Cheng Yee Lowe
Publisher: CRC Press
ISBN: 9781574910643
Category : Technology & Engineering
Languages : en
Pages : 286
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Book Description
Written by an expert with twenty years' experience in regulatory affairs in a number of multi-national companies, this book guides readers through the legislative minefield of registering medicinal products in the European Union. Taking a step-by-step approach, the book demystifies all of the regulatory requirements and gives a clear understanding of how to achieve compliance. The author gathers all the relevant requirements, puts them into context, and provides regulatory information in an easily accessible format. Headings, subheadings, and key points organized in tabular format make the information easy for readers to find and the book easy for readers to use.
Author: European Commission
Publisher: Bernan Press(PA)
ISBN: 9789282820322
Category : Medical
Languages : en
Pages : 304
Get Book Here
Book Description
A series governing medicinal products in the European Union. There are three volumes (including this one) covering products for human use, three covering veterinary medicinal products and one covering both. The volumes consist of legislation, notice to applicants, guidelines and good practice.
Author: Commission of the European Communities
Publisher:
ISBN: 9789282631669
Category : Drugs
Languages : en
Pages : 242
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Book Description
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 224
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Book Description
Author: James Hogan
Publisher: Springer
ISBN: 1349113441
Category : Business & Economics
Languages : en
Pages : 565
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Book Description
Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 666
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Book Description
First multi-year cumulation covers six years: 1965-70.
Author: Anthony C. Cartwright
Publisher: CRC Press
ISBN: 1420081837
Category : Medical
Languages : en
Pages : 804
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Book Description
Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies.The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update.This cutting-edge resou
Author: National Library of Medicine (U.S.)
Publisher:
ISBN:
Category : Medicine
Languages : en
Pages : 1184
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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: World Health Organization
Publisher: World Health Organization
ISBN: 9240099425
Category : Business & Economics
Languages : en
Pages : 1788
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Book Description
This publication represents a significant achievement in our ongoing effort to ensure that everyone can reach the highest possible level of health. Over the last three decades, we have seen the transformation of the pharmaceutical industry and the increasing intricacy of the product life cycle. The challenges we face today are very different from those we faced when the first edition of this Compendium was published in 1997. However, our mission remains the same: to promote health, keep the world safe and serve the vulnerable. The new edition reflects the collective knowledge and expertise of countless professionals who have worked diligently to develop, revise, and implement WHO guidelines for pharmaceuticals. This includes experts from WHO, Member States, our Expert Advisory Panels and Expert Committees on Specifications for Pharmaceutical Preparations and other organizations and has undergone extensive consultation with stakeholders worldwide. This Compendium covers development through manufacturing and quality control to post-marketing surveillance. It provides a comprehensive framework for quality assurance that is both strong and flexible, capable of meeting the requirements of a rapidly changing global health landscape. The 10th edition is a collection of knowledge and tools for empowerment, enabling all stakeholders in the pharmaceutical industry to make informed decisions that prioritize patient safety and well-being.
