International Cooperation Convergence and Harmonization of Pharmaceutical Regulations

International Cooperation  Convergence and Harmonization of Pharmaceutical Regulations
Author: Pierre-Louis Lezotre
Publsiher: Unknown
Total Pages: 349
Release: 2013-12-10
ISBN 10: 9780128000533
ISBN 13: 0128000538
Language: EN, FR, DE, ES & NL

International Cooperation Convergence and Harmonization of Pharmaceutical Regulations Book Review:

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 Cooperation Convergence and Harmonization of Pharmaceutical Regulations

International Cooperation  Convergence and Harmonization of Pharmaceutical Regulations
Author: Pierre-Louis Lezotre
Publsiher: Academic Press
Total Pages: 376
Release: 2013-12-05
ISBN 10: 0128005696
ISBN 13: 9780128005699
Language: EN, FR, DE, ES & NL

International Cooperation Convergence and Harmonization of Pharmaceutical Regulations Book Review:

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
Author: Institute of Medicine,Board on Health Sciences Policy,Forum on Drug Discovery, Development, and Translation
Publsiher: National Academies Press
Total Pages: 128
Release: 2013-11-24
ISBN 10: 0309284791
ISBN 13: 9780309284790
Language: EN, FR, DE, ES & NL

International Regulatory Harmonization Amid Globalization of Drug Development Book Review:

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.

Dosage Form Design Parameters

Dosage Form Design Parameters
Author: Anonim
Publsiher: Academic Press
Total Pages: 810
Release: 2018-07-25
ISBN 10: 012814422X
ISBN 13: 9780128144220
Language: EN, FR, DE, ES & NL

Dosage Form Design Parameters Book Review:

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

Drug Safety in Developing Countries

Drug Safety in Developing Countries
Author: Yaser Mohammed Al-Worafi
Publsiher: Academic Press
Total Pages: 686
Release: 2020-06-03
ISBN 10: 0128204125
ISBN 13: 9780128204122
Language: EN, FR, DE, ES & NL

Drug Safety in Developing Countries Book Review:

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

Drugs Law and Legal Practice in Southeast Asia

Drugs Law and Legal Practice in Southeast Asia
Author: Tim Lindsey,Pip Nicholson
Publsiher: Bloomsbury Publishing
Total Pages: 408
Release: 2016-07-28
ISBN 10: 1782258337
ISBN 13: 9781782258339
Language: EN, FR, DE, ES & NL

Drugs Law and Legal Practice in Southeast Asia Book Review:

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.

Pharmacovigilance

Pharmacovigilance
Author: I. Ralph Edwards,Marie Lindquist
Publsiher: Springer
Total Pages: 205
Release: 2016-10-27
ISBN 10: 3319404008
ISBN 13: 9783319404004
Language: EN, FR, DE, ES & NL

Pharmacovigilance Book Review:

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.

Energy Management Collective and Computational Intelligence with Theory and Applications

Energy Management   Collective and Computational Intelligence with Theory and Applications
Author: Cengiz Kahraman,Gülgün Kayakutlu
Publsiher: Springer
Total Pages: 554
Release: 2018-03-21
ISBN 10: 3319756907
ISBN 13: 9783319756905
Language: EN, FR, DE, ES & NL

Energy Management Collective and Computational Intelligence with Theory and Applications Book Review:

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.

The SAGE Encyclopedia of Pharmacology and Society

The SAGE Encyclopedia of Pharmacology and Society
Author: Sarah E. Boslaugh
Publsiher: SAGE Publications
Total Pages: 1888
Release: 2015-09-15
ISBN 10: 1506301320
ISBN 13: 9781506301327
Language: EN, FR, DE, ES & NL

The SAGE Encyclopedia of Pharmacology and Society Book Review:

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.

Pharmaceuticals in the European Union

Pharmaceuticals in the European Union
Author: Giuditta Savonitto
Publsiher: Cambridge Scholars Publishing
Total Pages: 189
Release: 2019-04-23
ISBN 10: 1527533603
ISBN 13: 9781527533608
Language: EN, FR, DE, ES & NL

Pharmaceuticals in the European Union Book Review:

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.

Contemporary Healthcare Issues in Sub Saharan Africa

Contemporary Healthcare Issues in Sub Saharan Africa
Author: Edward Nketiah-Amponsah,Oluwatoyin A. Odeku
Publsiher: Rowman & Littlefield
Total Pages: 262
Release: 2021-05-03
ISBN 10: 1793633703
ISBN 13: 9781793633705
Language: EN, FR, DE, ES & NL

Contemporary Healthcare Issues in Sub Saharan Africa Book Review:

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.

Food and Drug Regulation in an Era of Globalized Markets

Food and Drug Regulation in an Era of Globalized Markets
Author: Sam F Halabi
Publsiher: Academic Press
Total Pages: 264
Release: 2015-08-31
ISBN 10: 0128025506
ISBN 13: 9780128025505
Language: EN, FR, DE, ES & NL

Food and Drug Regulation in an Era of Globalized Markets Book Review:

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

Governing Climate Change

Governing Climate Change
Author: Jolene Lin
Publsiher: Cambridge Studies on Environme
Total Pages: 280
Release: 2018-06-21
ISBN 10: 1108424856
ISBN 13: 9781108424851
Language: EN, FR, DE, ES & NL

Governing Climate Change Book Review:

First systematic study of global cities as lawmakers in the world of transnational climate change governance.

Medicinal and Aromatic Plants of the World Africa

Medicinal and Aromatic Plants of the World   Africa
Author: Mohamed Neffati,Hanen Najjaa,Ákos Máthé
Publsiher: Springer
Total Pages: 411
Release: 2017-09-07
ISBN 10: 9402411208
ISBN 13: 9789402411201
Language: EN, FR, DE, ES & NL

Medicinal and Aromatic Plants of the World Africa Book Review:

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.

Regulating Medicines in a Globalized World

Regulating Medicines in a Globalized World
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines
Publsiher: National Academies Press
Total Pages: 168
Release: 2020-04-25
ISBN 10: 0309498635
ISBN 13: 9780309498630
Language: EN, FR, DE, ES & NL

Regulating Medicines in a Globalized World Book Review:

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.

Regulating Medicines in a Globalized World

Regulating Medicines in a Globalized World
Author: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines
Publsiher: National Academies Press
Total Pages: 168
Release: 2020-03-25
ISBN 10: 030949866X
ISBN 13: 9780309498661
Language: EN, FR, DE, ES & NL

Regulating Medicines in a Globalized World Book Review:

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.

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
Author: Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries
Publsiher: National Academies Press
Total Pages: 366
Release: 2012-09-03
ISBN 10: 030922408X
ISBN 13: 9780309224086
Language: EN, FR, DE, ES & NL

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Book Review:

A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.

Pharmaceutical Medicine and Translational Clinical Research

Pharmaceutical Medicine and Translational Clinical Research
Author: Divya Vohora,Gursharan Singh
Publsiher: Academic Press
Total Pages: 526
Release: 2017-11-14
ISBN 10: 0128020989
ISBN 13: 9780128020982
Language: EN, FR, DE, ES & NL

Pharmaceutical Medicine and Translational Clinical Research Book Review:

Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery

GLOBAL PHARMACEUTICAL AND BIOLOGICS REGULATORY STRATEGY

GLOBAL PHARMACEUTICAL AND BIOLOGICS REGULATORY STRATEGY
Author: Anonim
Publsiher: Unknown
Total Pages: 329
Release: 2016
ISBN 10: 9780996949156
ISBN 13: 0996949151
Language: EN, FR, DE, ES & NL

GLOBAL PHARMACEUTICAL AND BIOLOGICS REGULATORY STRATEGY Book Review:

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

Threat Posed by the Convergence of Organized Crime  Drug Trafficking  and Terrorism
Author: Bill McCollum
Publsiher: DIANE Publishing
Total Pages: 66
Release: 2002-04
ISBN 10: 9780756720827
ISBN 13: 0756720826
Language: EN, FR, DE, ES & NL

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

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.