Neuroscience Trials of the Future

Neuroscience Trials of the Future

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2016-11-07

Total Pages: 111

ISBN-13: 0309442583

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On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.


Regulating Medicines in a Globalized World

Regulating Medicines in a Globalized World

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2020-04-25

Total Pages: 169

ISBN-13: 0309498635

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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 Global Anti-Money Laundering Regulatory Landscape in Less Developed Countries

The Global Anti-Money Laundering Regulatory Landscape in Less Developed Countries

Author: Dr Norman Mugarura

Publisher: Ashgate Publishing, Ltd.

Published: 2012-08-01

Total Pages: 532

ISBN-13: 1409456617

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Examining the challenges of using the global anti-money laundering (AML) framework in an uneven global regulatory landscape, this book discusses the difficulties of relating de-regulation, liberalization and conflict of laws to the dynamics of the market economy and demonstrates how the global environment engenders money laundering. It suggests that corruption, general systemic failure and lack of infrastructural capacity in some developing economies are hampering the implementation of laws and regulations. Suggesting that these challenges can be overcome by designing AML regimes more suited to developing economies within the prevailing global climate, the book questions the assumption that that global regimes will be applicable and emphasises the need for more representation of developing economies on the relevant committees. This book is the first of its kind to present the perspective of developing economies and their involvement in AML regimes and should be of interest to those involved in business and commercial law as well as comparative law.


Returning Individual Research Results to Participants

Returning Individual Research Results to Participants

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-08-23

Total Pages: 399

ISBN-13: 0309475201

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When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.


China's Regulatory State

China's Regulatory State

Author: Roselyn Hsueh Romano

Publisher: Cornell University Press

Published: 2011-10-15

Total Pages: 321

ISBN-13: 0801462851

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Today's China is governed by a new economic model that marks a radical break from the Mao and Deng eras; it departs fundamentally from both the East Asian developmental state and its own Communist past. It has not, however, adopted a liberal economic model. China has retained elements of statist control even though it has liberalized foreign direct investment more than any other developing country in recent years. This mode of global economic integration reveals much about China’s state capacity and development strategy, which is based on retaining government control over critical sectors while meeting commitments made to the World Trade Organization. In China's Regulatory State, Roselyn Hsueh demonstrates that China only appears to be a more liberal state; even as it introduces competition and devolves economic decisionmaking, the state has selectively imposed new regulations at the sectoral level, asserting and even tightening control over industry and market development, to achieve state goals. By investigating in depth how China implemented its economic policies between 1978 and 2010, Hsueh gives the most complete picture yet of China's regulatory state, particularly as it has shaped the telecommunications and textiles industries. Hsueh contends that a logic of strategic value explains how the state, with its different levels of authority and maze of bureaucracies, interacts with new economic stakeholders to enhance its control in certain economic sectors while relinquishing control in others. Sectoral characteristics determine policy specifics although the organization of institutions and boom-bust cycles influence how the state reformulates old rules and creates new ones to maximize benefits and minimize costs after an initial phase of liberalization. This pathbreaking analysis of state goals, government-business relations, and methods of governance across industries in China also considers Japan’s, South Korea’s, and Taiwan’s manifestly different approaches to globalization.


Regulatory Landscape

Regulatory Landscape

Author: United States. Congress. House. Committee on Small Business. Subcommittee on Investigations, Oversight, and Regulations

Publisher:

Published: 2014

Total Pages: 88

ISBN-13:

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Regulatory Aspects of Artificial Intelligence on Blockchain

Regulatory Aspects of Artificial Intelligence on Blockchain

Author: Tehrani, Pardis Moslemzadeh

Publisher: IGI Global

Published: 2021-09-24

Total Pages: 273

ISBN-13: 1799879291

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The convergence of Artificial Intelligence (AI) in blockchain creates one of the world’s most reliable technology-enabled decision-making systems that is virtually tamper-proof and provides solid insights and decisions. The integration of AI and Blockchain affects many aspects from food supply chain logistics and healthcare record sharing to media royalties and financial security. It is imperative that regulatory standards are emphasized in order to support positive outcomes from the integration of AI in blockchain technology. Regulatory Aspects of Artificial Intelligence on Blockchain provides relevant legal and security frameworks and the latest empirical research findings in blockchain and AI. Through the latest research and standards, the book identifies and offers solutions for overcoming legal consequences that pertain to the application of AI into the blockchain system, especially concerning the usage of smart contracts. The chapters, while investigating the legal and security issues associated with these applications, also include topics such as smart contacts, network vulnerability, cryptocurrency, machine learning, and more. This book is essential for technologists, security analysts, legal specialists, privacy and data security practitioners, IT consultants, standardization professionals, researchers, academicians, and students interested in blockchain and AI from a legal and security viewpoint.


The AI Book

The AI Book

Author: Ivana Bartoletti

Publisher: John Wiley & Sons

Published: 2020-06-29

Total Pages: 304

ISBN-13: 1119551900

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Written by prominent thought leaders in the global fintech space, The AI Book aggregates diverse expertise into a single, informative volume and explains what artifical intelligence really means and how it can be used across financial services today. Key industry developments are explained in detail, and critical insights from cutting-edge practitioners offer first-hand information and lessons learned. Coverage includes: · Understanding the AI Portfolio: from machine learning to chatbots, to natural language processing (NLP); a deep dive into the Machine Intelligence Landscape; essentials on core technologies, rethinking enterprise, rethinking industries, rethinking humans; quantum computing and next-generation AI · AI experimentation and embedded usage, and the change in business model, value proposition, organisation, customer and co-worker experiences in today’s Financial Services Industry · The future state of financial services and capital markets – what’s next for the real-world implementation of AITech? · The innovating customer – users are not waiting for the financial services industry to work out how AI can re-shape their sector, profitability and competitiveness · Boardroom issues created and magnified by AI trends, including conduct, regulation & oversight in an algo-driven world, cybersecurity, diversity & inclusion, data privacy, the ‘unbundled corporation’ & the future of work, social responsibility, sustainability, and the new leadership imperatives · Ethical considerations of deploying Al solutions and why explainable Al is so important


Non-Biological Complex Drugs

Non-Biological Complex Drugs

Author: Daan J.A. Crommelin

Publisher: Springer

Published: 2015-06-24

Total Pages: 390

ISBN-13: 3319162411

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The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table.