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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The BVIs FinTech Regulatory Sandbox aims to promote efficiencies, leverage technology for innovative financial solutions, provide regulatory clarity, and develop targeted responses. Eligible persons include startups proposing new financial services, innovative technologies for licensable services, a

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Update on COVID-19 vaccine regulatory status as of January 25, 2021, provided by Dr. B. Semete-Makokotlela, SAHPRA CEO. The update includes information on vaccine applications submitted to SAHPRA, regulatory reviews conducted, and Section 21 applications for vaccines like Janssen, AstraZeneca, and C

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The Regulatory Advisory Panel meeting held on October 14, 2020, at 3:30 p.m. covered roll call details of attendees from various organizations and agencies. The meeting focused on key members and workgroup organizations pertaining to health care, hospice, and regulatory affairs. Attendees were urged

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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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Hana Lee, Ph.D., presents a webinar on the Targeted Learning Framework for Causal Effect Estimation using Real World Data (TMLE). The project aims to help the FDA develop a structured approach to incorporating real-world data into regulatory decision-making. TMLE offers a systematic roadmap aligned

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NAMFISA, established under the NAMFISA Act of 2001, exercises supervision over financial institutions and services in Namibia. The organization recently underwent an organizational restructuring to optimize resources and enhance efficiency. They oversee a broad regulatory scope covering various fina

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The regulatory update introduces the revision of Annex 1 by Greg McGurk on June 13th, 2018, emphasizing the history, process, and rationale for the revision. Key stakeholders, including regulatory bodies and industry players, are outlined, showcasing the global impact and need for alignment with cur

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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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Learn about regulatory inspections, what to expect, and how to achieve the best outcomes in this comprehensive guide. Explore key areas reviewed, post-inspection engagement strategies, corporate strategies vs regulatory outcomes, and practical tips for handling inspections effectively.

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The regulatory landscape for in-house solicitors engaging in pro bono work presents challenges and opportunities. While there are few restrictions on their practice, navigating SRA rules and obtaining clarity on pro bono activities can be complex. Available regulatory guidance covers statutory rules

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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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This chapter delves into the importance of managing state letters, notification and publication of differences, and the development and review of primary legislation, operating regulations, and technical guidance materials in the context of aviation regulatory frameworks. It covers topics like the m

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Regulatory cooperation and reliance on international standards play a crucial role in facilitating access to essential medical products. The TBT Agreement emphasizes the use of international standards, conformity assessment procedures, and transparency to address trade and regulatory bottlenecks. By

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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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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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FDA showcases illustrative examples of how Real-World Evidence (RWE) has been utilized in regulatory decisions, highlighting its value across different submission types, data sources, and purposes from FY12-FY19. The FDA report features cases like a modified hemodialysis catheter end cap, tumor prof

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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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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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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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A detailed analysis of AI risk management practices in the EU and U.S., showcasing key differences in regulatory approaches and implications for technology transfer and commercial applications. The comparison covers subfields such as AI for human processes, socioeconomic decisions, consumer products

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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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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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Operational, decommissioning, and investment decisions in the power sector are influenced by different categories of costs. Operational decisions focus on variable costs like fuel and CO2 expenses, while decommissioning decisions consider both variable and fixed costs. Investment decisions require a

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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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The Indian Board of Indian Appeals (IBIA) exercises delegated authority from the Secretary of the Interior to provide independent review of decisions made by Bureau of Indian Affairs (BIA) officials. The IBIA consists of three administrative law judges and considers appeals on various issues such as

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