This article provides insights into the status, regulatory considerations, and delivery methods of gene therapy and genome editing technologies. It discusses approved gene therapies in the US, human genome editing in clinical applications, and the regulatory authority of the FDA over gene therapy. T

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This initiative in Sarawak focuses on simplifying the business licensing process through regulatory experiments aimed at reducing regulatory burdens and improving the overall business ecosystem. By implementing innovative strategies such as risk-based approvals and composite licenses, the goal is to

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The regulatory framework of SMEs, particularly within the Iberoamerican Network of Guarantees (REGAR), showcases the establishment and operations of guarantee schemes in various countries such as Spain, Mexico, Portugal, and others. The warranty industry has witnessed global expansion with diverse m

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The Regulatory Update presented by Mark Foy, Chief Executive, and Chief Nuclear Inspector at the ONR NGO Forum highlighted key areas of focus including ethics, future strategies, and regulatory advancements in the nuclear industry. The forum also featured insights from Donald Urquhart, Executive Dir

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Explore the comprehensive planning drivers, regulatory challenges, and implementation pathways in the environmental protection domain. Key elements include the strategic roadmap, funding priorities, regulatory analysis, and collaborative permitting strategies. Navigate the complexities of environmen

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Guam's Regulatory Aquifer Mapping includes conflicting maps from USEPA, the Northern Guam Lens Study, and Groundwater Protection Zones, impacting land use regulations and water quality standards. Issues arise from inconsistencies in regulatory tools and language errors within the protection zones. Z

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In today's rapidly evolving global trade landscape, the logistics industry is no stranger to constant regulatory changes. These changes not only affect operational procedures but also have a significant impact on cargo pricing technology. As revenue technology services continue to innovate to meet t

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In the heart of Dusseldorf, Germany, the MarketsandMarkets European Medical Device & Diagnostics Regulatory, Compliance, Post-Market Surveillance and Vigilance Conference is set to unfold on the 14th and 15th of October 2024.\n\nRegister Now @ \/\/events.marketsandmarkets.com\/european-medical-devic

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The co-chairs of the Task Force on Regulatory Fitness for Automated Driving Systems presented an informal document at the 19th meeting of GRVA, outlining the context, purpose, and status of regulations related to automated vehicles. The report focuses on the need for a regulatory environment for aut

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This Safety Guide aims to assist regulatory bodies in managing regulatory experience by identifying sources, establishing means for information exchange, and implementing record-keeping processes. It addresses the need for cooperation and knowledge sharing among regulatory bodies to enhance safety s

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Policy-making involves defining policy, recognizing its complex nature, identifying windows of opportunity, and framing health issues. The policy-making cycle includes stages like agenda setting, formulation, and implementation. Alignment of problems, policies, and politics is crucial for effective

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A policy brief is a compelling document designed to influence decision-makers by outlining policy alternatives and courses of action. Discover the value of policy briefs, effective characteristics, and strategies for agenda setting and policy formulation in this comprehensive module.

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The policy cycle theory describes the evolution of policy issues from inception to evaluation, impacting scientific research and policy formulation. It outlines stages from the 1950s, influenced by Lasswell's seven-stage model, serving as a framework for organizing policy processes. Despite the line

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The discussion at the ISPOR Annual Meeting focused on defining regulatory-grade real-world data (RWD) sources as those of adequate quality for specific regulatory purposes. Panelists emphasized the importance of authenticity, transparency, accuracy, and track record in evaluating data quality. They

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This presentation to the Portfolio Committee on Mineral Resources and Energy delves into the Basic Fuel Price (BFP) for liquid fuels, covering global fuel pricing forms, policy positions, key pricing mechanisms, regulatory mandates, and the intricate structure behind fuel prices. It explains how the

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This session delves into the regulatory landscape focusing on the objectives, types, and origins of regulations in the financial sector, particularly in Nigeria. It discusses the essential role of regulation in promoting compliance, protecting stakeholders, and maintaining operational integrity with

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This presentation by the Council for the Built Environment (CBE) outlines the Identification of Work (IDoW) Policy, elucidating key regulatory mechanisms, acronyms, definitions, and the role of the CBE in implementing and evaluating such mechanisms in the built environment sector. The purpose is to

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Regulatory enzymes play a crucial role in controlling the activity of biochemical pathways by responding to the presence of specific molecules. They regulate the pathway's activity, ensuring that products are produced in the required amounts at different times. This article delves into the significa

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The content discusses the challenges faced in policy implementation, focusing on the gap between policy design and execution. It highlights key steps in policy-making, reasons for implementation failures, and factors influencing successful policy outcomes. Examples from Zambia's National Science and

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The Protecting our Infrastructure of Pipelines and Enhancing Safety Act of 2016 authorizes funding for PHMSA. Information on rulemakings can be found in DOT reports. The timeline for future rulemaking is pending on implementing Executive Orders. Enforcing the Regulatory Reform Agenda aims to allevia

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This information provides insights into the organizational structure and functions of the FDA Office of Regulatory Affairs (ORA) and the Office of Regulatory Science (ORS). It includes organizational charts, details about ORA laboratory locations, and the local structure of an ORA laboratory. Additi

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This document provides an overview of the proposed Nuclear Regulatory Commission (NRC) Safety Culture Policy Statement presented by Eric Fries, the Safety Culture Program Manager. It covers topics such as NRC's mission, responsibility, safety culture background, draft policy statement, current statu

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Regulation aims to correct market failures for societal welfare, but regulatory capture by interest groups can hinder regulatory actions. This work discusses economic theories on regulatory capture, forms of capture, and strategies to mitigate risks, emphasizing the public interest theory as a promo

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Protecting consumers and investors through effective regulation of accounting and corporate financial reporting is crucial. Regulatory cooperation offers benefits like simplifying the regulatory environment and enforcing best practices. However, regulatory competition can uncover limits and the adva

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Explore the intricacies of strategic planning, outcome mapping, change theories, policy windows, and more in the realm of policy entrepreneurship and advocacy. Learn about key concepts such as large leaps theory, policy streams theory, and how think tanks can influence policy decision-making process

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The Victorian Regulatory Change Measurement (RCM) methodology introduced in June 2010 aims to measure reductions in regulatory burden through different categories such as administrative costs, substantive compliance costs, delay costs, and more. The RCM formula helps in calculating the total regulat

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This presentation explores the rationale, rise, and structure of Statutory Regulatory Authorities (SRAs) in India within a constitutional framework. It discusses the importance of specialization, independence from political pressures, and global developments in regulatory agencies. The content delve

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Morality plays a significant role in shaping drug policy in the UK, as revealed by the research conducted by Professor Alex Stevens at the University of Kent. The study investigates the moral commitments underlying different policy positions in UK drug policy debates, highlighting five ethico-politi

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Start/end date for WP5.1 initiative is M7-M24, led by CONFAGRI.PT and partners. The project aims to prepare the roll-out of deliverables at national and regional levels, focusing on regulatory frameworks, sustainability plan, and stakeholder engagement. Various organizations contribute to provide EU

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Industrial policy, as presented by Dani Rodrik in May 2019, emphasizes the importance of empirical work, the differences between old and new policies, and the targets industrial policy should focus on. The theoretical arguments for industrial policy highlight market imperfections, learning spillover

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Various tools and approaches are discussed to improve policy making, including foresight, cost-benefit analysis, and regulatory tools. The changing context of policy challenges is highlighted, along with the OECD policy toolkit's modular approach. Strategies like talking to leaders, engaging stakeho

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The Estonian experience on regulatory and tax policy in tobacco and nicotine products highlights the implementation of strategies such as e-liquid tax breaks and excise duty differentiation based on harm caused. The initiative aims to reduce the black market, make legal products more affordable, and

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The evolution of US environmental and regulatory policy is traced from the bipartisan period of the New Deal to current challenges in addressing issues like climate change and COVID-19. Key transitions include bipartisan support for major environmental laws, the Reagan shift towards smaller governme

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This article explores the adoption of Regulatory Impact Assessment (RIA) in India, discussing the political economy challenges and strategies to overcome roadblocks. It outlines the working definition of RIA, addresses potential opposition from politicians and bureaucrats, and suggests ways to gener

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Good Regulatory Practice (GRP) is a key aspect of regulatory policy that focuses on improving the quality and cost-effectiveness of domestic regulations. It involves internationally recognized processes such as impact assessment, regulatory transparency, participation, and accountability. The import

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Former European Commission Official, Jacques McMillan, delves into the topic of accreditation fulfilling expectations in regulatory policy for the free movement of goods and market surveillance. He discusses the evolution from product-focused approaches to including framework elements, the New Appro

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The executive review delves into regulatory materials from various chapters, highlighting both successes and failures within the regulatory landscape. It explores the tension in rulemaking, public perception of risk, and the role of non-agency regulation in tort and compensation law. The discussion

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Policy formulation is a crucial step in the policy-making process, involving identifying and crafting policy alternatives to address various issues. This phase requires participants to define policy problems, develop alternatives, and select the most feasible solutions based on criteria such as feas

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Explore theories of regulation, critiques of regulatory policy, regulatory successes in public health and banking, criminal law as regulation, economic theories of regulation, and more. Consider the internalization of costs, correction of informational and bargaining asymmetries, optimization and pr

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Federal agencies express systemic concerns over captive transactions, emphasizing the importance of distinguishing between different types of captives. The NAIC Solvency Framework aims to establish a consistent baseline for accounting practices in the insurance industry while allowing for flexibilit

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