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
Genre: Medical
ISBN: 9780128005699

Download International Cooperation Convergence and Harmonization of Pharmaceutical Regulations Book in PDF, Epub and Kindle

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
Genre: Medical
ISBN: 9780309284790

Download International Regulatory Harmonization Amid Globalization of Drug Development Book in PDF, Epub and Kindle

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.

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
Genre: Medical
ISBN: 9780309498630

Download Regulating Medicines in a Globalized World Book in PDF, Epub and Kindle

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.

The Interplay of Global Standards and EU Pharmaceutical Regulation

The Interplay of Global Standards and EU Pharmaceutical Regulation
Author: Sabrina Röttger-Wirtz
Publsiher: Bloomsbury Publishing
Total Pages: 288
Release: 2021-08-26
Genre: Law
ISBN: 9781509943012

Download The Interplay of Global Standards and EU Pharmaceutical Regulation Book in PDF, Epub and Kindle

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.

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
Author: World Intellectual Property Organization
Publsiher: WIPO
Total Pages: 257
Release: 2013
Genre: Law
ISBN: 9789280523089

Download Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade Book in PDF, Epub and Kindle

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.

Rethinking Participation in Global Governance

Rethinking Participation in Global Governance
Author: Joost Pauwelyn,Professor of International Law Joost Pauwelyn,Martino Maggetti,Professor and Chair for International Relations Tim Büthe,Tim Büthe,Adjunct Assistant Professor Ayelet Berman,Ayelet Berman
Publsiher: Oxford University Press
Total Pages: 592
Release: 2022-03-31
Genre: Electronic Book
ISBN: 9780198852568

Download Rethinking Participation in Global Governance Book in PDF, Epub and Kindle

This addition to the Law and Global Governance Series examines participation of stakeholders in treaty-based intergovernmental organizations. Readers are offered a comprehensive account of what has been done to facilitate the participation of previously neglected stakeholders.

Ethics in Nanotechnology

Ethics in Nanotechnology
Author: Marcel Van de Voorde,Gunjan Jeswani
Publsiher: Walter de Gruyter GmbH & Co KG
Total Pages: 363
Release: 2021-09-06
Genre: Technology & Engineering
ISBN: 9783110701975

Download Ethics in Nanotechnology Book in PDF, Epub and Kindle

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
Author: Anonim
Publsiher: Academic Press
Total Pages: 810
Release: 2018-07-25
Genre: Medical
ISBN: 9780128144220

Download Dosage Form Design Parameters Book in PDF, Epub and Kindle

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

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
Genre: Medical
ISBN: 9780309224086

Download Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad Book in PDF, Epub and Kindle

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.

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
Genre: Law
ISBN: 9781782258339

Download Drugs Law and Legal Practice in Southeast Asia Book in PDF, Epub and Kindle

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
Author: Yaser Mohammed Al-Worafi
Publsiher: Academic Press
Total Pages: 686
Release: 2020-06-03
Genre: Business & Economics
ISBN: 9780128204122

Download Drug Safety in Developing Countries Book in PDF, Epub and Kindle

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
Author: I. Ralph Edwards,Marie Lindquist
Publsiher: Springer
Total Pages: 205
Release: 2016-10-27
Genre: Medical
ISBN: 9783319404004

Download Pharmacovigilance Book in PDF, Epub and Kindle

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
Genre: Technology & Engineering
ISBN: 9783319756905

Download Energy Management Collective and Computational Intelligence with Theory and Applications Book in PDF, Epub and Kindle

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.

Pharmaceuticals in the European Union

Pharmaceuticals in the European Union
Author: Giuditta Savonitto
Publsiher: Cambridge Scholars Publishing
Total Pages: 189
Release: 2019-04-23
Genre: Political Science
ISBN: 9781527533608

Download Pharmaceuticals in the European Union Book in PDF, Epub and Kindle

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.

WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices

WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices
Author: World Health Organization
Publsiher: Unknown
Total Pages: 72
Release: 2017-05-09
Genre: Law
ISBN: 9241512350

Download WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices Book in PDF, Epub and Kindle

The Model recommends guiding principles and harmonized definitions and specifies the attributes of effective and efficient regulation to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF). The Model is particularly relevant for WHO Member States with little or no regulation for medical devices currently in place but with the ambition to improve this situation. It foresees that such countries will progress from basic regulatory controls towards an expanded level to the extent that their resources allow. The Model is written for the legislative, executive, and regulatory branches of government as they develop and establish a system of medical devices regulation. It describes the role and responsibilities of a country's regulatory authority for implementing and enforcing the regulations. Also, it describes circumstances in which a regulatory authority may either "rely on" or "recognize" the work products from trusted regulatory sources (such as scientific assessments, audit, and inspection reports) or from the WHO Prequalification Team. Section 2 of this document recommends definitions of the terms "medical devices" and IVDs. It describes how they may be grouped according to their potential for harm to the patient or user and specifies principles of safety and performance that the device manufacturer must adhere to. It explains how the manufacturer must demonstrate to a regulatory authority that its medical device has been designed and manufactured to be safe and to perform as intended during its lifetime. Section 3 presents the principles of good regulatory practice and enabling conditions for effectively regulating medical devices. It then introduces essential tools for regulation, explaining the function of the regulatory entity and the resources required. Section 4 presents a stepwise approach to implementing and enforcing regulatory controls for medical devices as the regulation progresses from a basic to an expanded level. It describes elements from which a country may choose according to national priorities and challenges. Also, it provides information on when the techniques of reliance and recognition may be considered and on the importance of international convergence of regulatory practice.Section 5 provides a list of additional topics to be considered when developing and implementing regulations for medical devices. It explains the relevance of these topics and provides guidance for regulatory authorities to ensure that they are addressed appropriately. The Model outlines a general approach but cannot provide country-specific guidance on implementation. While it does not offer detailed guidance on regulatory topics, it contains references to relevant documents where further information may be found. It does not detail the responsibilities of other stakeholders such as manufacturers, distributors, procurement agencies, and health-care professionals, all of whom have roles in assuring the quality, safety, and performance of medical devices.