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International Cooperation Convergence And Harmonization Of Pharmaceutical Regulations

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International Cooperation Convergence and Harmonization of Pharmaceutical Regulations

International Cooperation  Convergence and Harmonization of Pharmaceutical Regulations Book
Author : Pierre-Louis Lezotre
Publisher : Academic Press
Release : 2013-12-05
ISBN : 0128005696
Language : En, Es, Fr & De

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Book Description :

International Cooperation, Convergence and Harmonization of Pharmaceutical Regulations: A Global Perspective provides the current status of the complex and broad phenomenon of cooperation, convergence and harmonization in the pharmaceutical sector (Part I), thoroughly evaluates its added value and its critical parameters and influencing factors (Part II) in order to recommend actions and measures to support the next steps for cooperation, convergence and harmonization (Part III). All of these recommendations in the book support the establishment of a better coordinated global pharmaceutical system which represents the best realistic alternative to fulfill the objective to establish a global coalition of regulators and to respond to an increased demand to further cooperation in the pharmaceutical sector. This proposed framework, which leverages all of the ongoing positive cooperation initiatives and uses as foundations all of the numerous harmonization projects developed over the years, presents advantages for all stakeholders and would definitively have significant added value to the promotion and protection of global public health. The status of all major worldwide harmonization and cooperation initiatives (at bilateral, regional, and global levels) The value of cooperation in the pharmaceutical sector and the driving factors behind harmonization The proposition of a structure for the global pharmaceutical system and timely recommendations for enhancing international cooperation, as well as further discussion and policy changes in this area

International Regulatory Harmonization Amid Globalization of Drug Development

International Regulatory Harmonization Amid Globalization of Drug Development Book
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publisher : National Academies Press
Release : 2013-11-24
ISBN : 0309284791
Language : En, Es, Fr & De

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Book Description :

The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.

The Interplay of Global Standards and EU Pharmaceutical Regulation

The Interplay of Global Standards and EU Pharmaceutical Regulation Book
Author : Sabrina Röttger-Wirtz
Publisher : Bloomsbury Publishing
Release : 2021-08-26
ISBN : 1509943013
Language : En, Es, Fr & De

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Book Description :

This book analyses the implementation of global pharmaceutical impact standards in the European risk regulation framework for pharmaceuticals and questions its legitimacy. Global standards increasingly shape the risk regulation law and policy in the European Union and the area of pharmaceuticals is no exception to this tendency. As this book shows, global pharmaceutical standards set by the International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), after they are adopted through the European Medicines Agency (EMA), are an important feature of the regulatory framework for pharmaceuticals in the EU. In addition to analysing the influence of these global standards in the EU legal and policy framework, the book questions the legitimacy of the Union's reliance on global standards in terms of core administrative law principles of participation, transparency and independence of expertise. It also critically examines the accountability of the European Commission and the European Medicines Agency as participants in the global standard-setting and main implementation gateway of the global pharmaceutical standards into the European Union.

Ethics in Nanotechnology

Ethics in Nanotechnology Book
Author : Marcel Van de Voorde,Gunjan Jeswani
Publisher : Walter de Gruyter GmbH & Co KG
Release : 2021-09-06
ISBN : 3110701979
Language : En, Es, Fr & De

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Book Description :

With nanotechnology being a relatively new field, the questions regarding safety and ethics are steadily increasing with the development of the research. This book aims to give an overview on the ethics associated with employing nanoscience for products with everyday applications. The risks as well as the regulations are discussed, and an outlook for the future of nanoscience on a manufacturer’s scale and for the society is provided. Ethics in nanotechnology is a valuable resource for, philosophers, academicians and scientist, as well as all other industry professionals and researchers who interact with emerging social and philosophical ethical issues on routine bases. It is especially for deep learners who are enthusiastic to apprehend the challenges related to nanotechnology and ethics in philosophical and social education. This book presents an overview of new and emerging nanotechnologies and their societal and ethical implications. It is meant for students, academics, scientists, engineers, policy makers, ethicist, philosophers and all stakeholders involved in the development and use of nanotechnology.

Dosage Form Design Parameters

Dosage Form Design Parameters Book
Author : Anonim
Publisher : Academic Press
Release : 2018-07-25
ISBN : 012814422X
Language : En, Es, Fr & De

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Book Description :

Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Drugs Law and Legal Practice in Southeast Asia

Drugs Law and Legal Practice in Southeast Asia Book
Author : Tim Lindsey,Pip Nicholson
Publisher : Bloomsbury Publishing
Release : 2016-07-28
ISBN : 1782258337
Language : En, Es, Fr & De

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Book Description :

Drugs Law and Legal Practice in Southeast Asia investigates criminal law and practice relevant to drugs regulation in three Southeast Asian jurisdictions: Indonesia, Singapore and Vietnam. These jurisdictions represent a spectrum of approaches to drug regulation in Southeast Asia, highlighting differences in practice between civil and common law countries, and between liberal and authoritarian states. This book offers the first major English language empirical investigation and comparative analysis of regulation, jurisprudence, court procedure, and practices relating to drugs law enforcement in these three states.

Drug Safety in Developing Countries

Drug Safety in Developing Countries Book
Author : Yaser Mohammed Al-Worafi
Publisher : Academic Press
Release : 2020-06-03
ISBN : 0128204125
Language : En, Es, Fr & De

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Book Description :

Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues Describes current achievements of drug safety practice in developing countries Addresses the challenges of drug safety in developing countries Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety

Pharmacovigilance

Pharmacovigilance Book
Author : I. Ralph Edwards,Marie Lindquist
Publisher : Springer
Release : 2016-10-27
ISBN : 3319404008
Language : En, Es, Fr & De

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Book Description :

Written by experienced authors, this book offers expert personal views on what the current problems in pharmacovigilance are and how they should be solved. This book stems from thoughts and ideas discussed in a series of meetings of the International Society of Pharmacovigilance (ISoP), where concerns were raised that the current pharmacovigilance system is not delivering optimally to improve therapeutics in clinical practice. Pharmacovigilance of the future must be an active and integral part of health care delivery, and focus more on science and practices that support health professionals and patients in day-to-day care situations. To achieve this, a dynamic and sustainable development of vigilance must take precedence over the current excessive preoccupations with data processing and regulations; all aspects of medicines use and their effects need to be considered; and all stakeholders must be involved and engaged in an open and constructive debate. The work is essential reading for anyone who has an interest in safer use of medicines. It is intended to be equally challenging and rewarding, and sets out to stimulate a continuous debate on how pharmacovigilance can better meet the needs of health professionals and patients to achieve the aim of wise therapeutic decision making.

Pharmaceuticals in the European Union

Pharmaceuticals in the European Union Book
Author : Giuditta Savonitto
Publisher : Cambridge Scholars Publishing
Release : 2019-04-23
ISBN : 1527533603
Language : En, Es, Fr & De

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Book Description :

This book offers the first complete and up-to-date analysis of the European Union’s regulation of medicines. Through a reasoned description ranging from regulatory developments to the jurisprudence of the Court of Justice of the European Union, it delineates the current European pharmaceutical regulation system. Moreover, the economic and social implications caused by the market fragmentation linked to disparities in national pricing and reimbursement schemes of pharmaceuticals are also explored here. In what was theorized to be a patchwork of rules and roles, the potential growth of the pharmaceutical industry is hampered and important inequalities in patient access are growing. What will be the next moves of European Union legislation to address the aging of the population, the higher incidence of some diseases and the growing costs of innovative medicines? Answers to such questions are offered in this book.

The SAGE Encyclopedia of Pharmacology and Society

The SAGE Encyclopedia of Pharmacology and Society Book
Author : Sarah E. Boslaugh
Publisher : SAGE Publications
Release : 2015-09-15
ISBN : 1506301320
Language : En, Es, Fr & De

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Book Description :

The SAGE Encyclopedia of Pharmacology and Society explores the social and policy sides of the pharmaceutical industry and its pervasive influence in society. While many technical STM works explore the chemistry and biology of pharmacology and an equally large number of clinically oriented works focus on use of illegal drugs, substance abuse, and treatment, there is virtually nothing on the immensely huge business (“Big Pharma”) of creating, selling, consuming, and regulating legal drugs. With this new Encyclopedia, the topic of socioeconomic, business and consumer, and legal and ethical issues of the pharmaceutical industry in contemporary society around the world are addressed. Key Features: 800 signed articles, authored by prominent scholars, are arranged A-to-Z and published in a choice of electronic or print formats Although arranged A-to-Z, a Reader's Guide in the front matter groups articles by thematic areas Front matter also includes a Chronology highlighting significant developments in this field All articles conclude with Further Readings and Cross References to related articles Back matter includes an annotated Resource Guide to further research, a Glossary, Appendices (e.g., statistics on the amount and types of drugs prescribed, etc.), and a detailed Index The Index, Reader’s Guide, and Cross References combine for search-and-browse capabilities in the electronic edition The SAGE Encyclopedia of Pharmacology and Society is an authoritative and rigorous source addressing the pharmacology industry and how it influences society, making it a must-have reference for all academic libraries as a source for both students and researchers to utilize.

Energy Management Collective and Computational Intelligence with Theory and Applications

Energy Management   Collective and Computational Intelligence with Theory and Applications Book
Author : Cengiz Kahraman,Gülgün Kayakutlu
Publisher : Springer
Release : 2018-03-21
ISBN : 3319756907
Language : En, Es, Fr & De

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Book Description :

This book presents a selection of recently developed collective and computational intelligence techniques, which it subsequently applies to energy management problems ranging from performance analysis to economic analysis, and from strategic analysis to operational analysis, with didactic numerical examples. As a form of intelligence emerging from the collaboration and competition of individuals, collective and computational intelligence addresses new methodological, theoretical, and practical aspects of complex energy management problems. The book offers an excellent reference guide for practitioners, researchers, lecturers and postgraduate students pursuing research on intelligence in energy management. The contributing authors are recognized researchers in the energy research field.

Contemporary Healthcare Issues in Sub Saharan Africa

Contemporary Healthcare Issues in Sub Saharan Africa Book
Author : Edward Nketiah-Amponsah,Oluwatoyin A. Odeku
Publisher : Rowman & Littlefield
Release : 2021-05-03
ISBN : 1793633703
Language : En, Es, Fr & De

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Book Description :

This book discusses contemporary healthcare issues in Sub-Saharan Africa to identify deficiencies in the system and provide recommendations for strengthening healthcare on the continent. Experts in clinical medicine, economics, public health, and the social sciences provide in-depth analyses of current issues that blend theory and practice.

Governing Climate Change

Governing Climate Change Book
Author : Jolene Lin
Publisher : Cambridge University Press
Release : 2018-06-21
ISBN : 1108620965
Language : En, Es, Fr & De

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Book Description :

Cities are no longer just places to live in. They are significant actors on the global stage, and nowhere is this trend more prominent than in the world of transnational climate change governance (TCCG). Through transnational networks that form links between cities, states, international organizations, corporations, and civil society, cities are developing and implementing norms, practices, and voluntary standards across national boundaries. In introducing cities as transnational lawmakers, Jolene Lin provides an exciting new perspective on climate change law and policy, offering novel insights about the reconfiguration of the state and the nature of international lawmaking as the involvement of cities in TCCG blurs the public/private divide and the traditional strictures of 'domestic' versus 'international'. This illuminating book should be read by anyone interested in understanding how cities - in many cases, more than the countries in which they're located - are addressing the causes and consequences of climate change.

Food and Drug Regulation in an Era of Globalized Markets

Food and Drug Regulation in an Era of Globalized Markets Book
Author : Sam F Halabi
Publisher : Academic Press
Release : 2015-08-31
ISBN : 0128025506
Language : En, Es, Fr & De

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Book Description :

Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today’s markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India. From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges. Based on the 2014 O’Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation. Interdisciplinary approach allows readers to understand the varying perspectives involved in regulatory development Includes case studies to highlight harmonization efforts and challenges, and to provide practical insights for application going forward Provides a thorough assessment of supply chains, potential gaps, and means of anticipating and addressing issues Presents a comprehensive snapshot of changes in the food safety law in the United States and under international standards, including academic, industry and regulatory perspectives Addresses conflicts and cooperation between relevant US agencies including USDA, FDA, DEA, EPA, FTC and the Department of Commerce

WHO Expert Committee on Specifications for Pharmaceutical Preparations

WHO Expert Committee on Specifications for Pharmaceutical Preparations Book
Author : Anonim
Publisher : World Health Organization
Release : 2021-04-26
ISBN : 924002090X
Language : En, Es, Fr & De

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Book Description :

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines and provision of global regulatory tools. Standards are developed by the Expert Committee through worldwide consultation and an international consensus-building process. The following new guidance texts were adopted and recommended for use: Guidelines and guidance texts adopted by the Expert Committee on Specifications for Pharmaceutical Preparations; Points to consider when including Health Based Exposure Limits (HBELs) in cleaning validation; Good manufacturing practices: water for pharmaceutical use; Guideline on data integrity; WHO/United Nations Population Fund recommendations for condom storage and shipping temperatures; WHO/United Nations Population Fund guidance on testing of male latex condoms; WHO/United Nations Population Fund guidance on conducting post-market surveillance of condoms; WHO “Biowaiver List”: proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms; WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce; Good reliance practices in the regulation of medical products: high-level principles and considerations; and Good regulatory practices in the regulations of medical products. All of the above are included in this report and recommended for implementation.

Medicinal and Aromatic Plants of the World Africa Volume 3

Medicinal and Aromatic Plants of the World   Africa Volume 3 Book
Author : Mohamed Neffati,Hanen Najjaa,Ákos Máthé
Publisher : Springer
Release : 2017-09-07
ISBN : 9402411208
Language : En, Es, Fr & De

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Book Description :

This volume in the series is devoted to Africa, a continent that possesses a vast treasure of medicinal plants and has produced some exclusive materials for the world market. This volume is expected to strengthen the medicinal plant sector in African countries by making comprehensive information on medicinal and aromatic plants available to policy-makers and entrepreneurs. It can be used to frame effective policies and create an environment conducive to the growth of the plant-based medicine industry, bringing economic benefit to African nations. It will help health organizations to improve the health of their people by using their own resources and a less expensive system of medicine, which is accepted by African society. It could also lead scientific communities to increase R&D activities in the field.

Governing Science and Technology under the International Economic Order

Governing Science and Technology under the International Economic Order Book
Author : Shin-yi Peng,Han-Wei Liu,Ching-Fu Lin
Publisher : Edward Elgar Publishing
Release : 2018
ISBN : 1788115562
Language : En, Es, Fr & De

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Book Description :

Against the backdrop of the recent trend towards megaregional trade initiatives, this book addresses the most topical issues that lie at the intersection of law and technology. By assessing international law and the political economy, the contributing authors offer an enhanced understanding of the challenges of diverging regulatory approaches to innovation.

Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade

Promoting Access to Medical Technologies and Innovation   Intersections between Public Health  Intellectual Property and Trade Book
Author : World Intellectual Property Organization
Publisher : WIPO
Release : 2013
ISBN : 9280523082
Language : En, Es, Fr & De

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Book Description :

This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

Threat Posed by the Convergence of Organized Crime Drug Trafficking and Terrorism

Threat Posed by the Convergence of Organized Crime  Drug Trafficking  and Terrorism Book
Author : Bill McCollum
Publisher : DIANE Publishing
Release : 2002-04
ISBN : 9780756720827
Language : En, Es, Fr & De

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Book Description :

Witnesses: Frank Cilluffo, senior policy analyst and deputy dir., Center for Strategic and International Studies (CSIS); Donnie R. Marshall, Administrator, Drug Enforcement Admin. (DEA); Steven C. McCraw, Inspector-Deputy Assistant Dir., Information, Analysis, and Assessments Branch, Investigative Div., FBI; Ralf Mutschke, assist. dir., Sub-Directorate for Crimes Against Persons and Property, INTERPOL General Secretariat, Lyon, France; Raphael Perl, Specialist in International Affairs, Congressional Research (CRS), The Library of Congress; and Michael A. Sheehan, Ambassador-at-Large and Coordinator for Counterterrorism, U.S. Dept. of State.

Threat Posed by the Convergence of Organized Crime Drug Trafficking and Terrorism

Threat Posed by the Convergence of Organized Crime  Drug Trafficking  and Terrorism Book
Author : United States. Congress. House. Committee on the Judiciary. Subcommittee on Crime
Publisher : Unknown
Release : 2000
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

Download Threat Posed by the Convergence of Organized Crime Drug Trafficking and Terrorism book written by United States. Congress. House. Committee on the Judiciary. Subcommittee on Crime, available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.