outlining risks and opportunities -to the regulatory strategy. This table provides a source of competitive and business intelligence websites. Most of the databases listed below are journal indexes that may provide the full-text of a journal article. We embrace proper regulatory compliance in the Linux kernel by making it part of cfg80211, used by new wireless drivers.We maintain a thorough and flexible regulatory database in userspace and provide a Central Regulatory Domain Agent (CRDA), a userspace agent, which can be triggered to update the kernel wireless core's definition of the regulatory permissions for a specific country. We offer up-to-date premium information on the electronic cigarette industry worldwide, including market and regulatory analysis, legal tracking and actionable data insights. Focus, September 2002, pg. Looking for abbreviations of GRID? With the advancement of scientific knowledge on various aspects of Chemicals such as safety and Regulatory affairs, it has become clear that proper review is essential on the use of chemicals. PDF - 19.6MB. At the same time, companies need to convey their . TobaccoIntelligence global alerts database: February. Tarius supports your regulatory intelligence activities by providing access in one place to global regulatory information for the healthcare industry on Human Drugs, Biologics, Medical Devices, and IVDs. A strategy must be in place to react to the legislations introduced as a result of new innovation. It is . About this Database. Regulatory Information Management System (RIMS) RIMS (Regulatory Information Management System) allows companies to team up, preserve application information data from various locations and enhance the processes of preparing a submission, as well as simplify the publishing and tracking of all regulatory activities that support a product's complete life cycle. All sources, summarized in one place. regulatory reports. Bula empowers by delivering simplified current law, legislative, regulatory & sub-regulatory information in an accurate, timely & meaningful manner. CHOOSE CALYX RIM. Regulatory Alerts, Updates, Newsletters, Journals, Subscriptions and Services. The New Digital Pathway for Regulatory. Regulatory Intelligence and Data Integrity Program Published on September 7, 2018 September 7, 2018 • 16 Likes • 0 Comments Clients of the new services will have access to an NIS Regulatory Intelligence Database , the first of its kind. Error-Free Regulatory Information Management. Regulatory Data Sheets (RDS) Regulatory Data Sheets (RDS) provide a clear overview of the regulatory status of substances or mixtures at product level. Regulatory risk management. Overview. U.S. Regulatory Intelligence Database. ClinRegs is an online database of country-specific clinical research regulatory information designed to assist in planning and implementing international clinical research. Long noncoding RNAs (lncRNAs) have been proven to play important roles in transcriptional processes and biological functions. RDS include the information on the following: … Medical Device Regulatory Intelligence Platform. IQVIA has a vision that goes beyond simply optimizing individual safety, regulatory, quality, and compliance functions. Regulatory Information Search for FDA guidance documents, learn about the laws enforced by FDA, and more. Regulatory Intelligence Database (RID) COMPANY PROFILE • A global Contract Research Organization (CRO) in a highly competitive industry • More than 50,000 employees working in over 100 countries worldwide handling some of the most complex clinical drug trials Table 4. Business Intelligence Websites. Regulatory Intelligence: How AI will change regulatory operations . Subscribe to our weekly Regulatory Activity Reports. What+is+Regulatory+Intelligence?+ "Act of gathering and analyzing regulatory information and monitoring current regulatory climate …" Regulatory Intelligence 101, M. Brown Tuttle … and using this data to generate creative and innovative regulatory strategies designed to obtain and maintain product approvals in a timely and efficient manner. Data Scouting Services, Regulatory Intelligence and Scientific Report Writing. Process monitoring capabilities for distribution on local, regional . One of the greatest sources of RI can be found in the press and knowing where to find the journals is key. As one of the most regulated industries, pharmaceutical and medical device manufacturing requires constant regulatory approval of new products. With a unique combination of smart technology and subject experts, you will get up to date requirements and trusted insights accurately and much faster. Regulatory intelligence (RI) is relatively a new arm of global regulatory affairs (RA). Feature articles during March focused on regulatory intelligence (RI), including first-hand accounts of setting up a dedicated process for RI monitoring and developing an in-house RI database, as well as an examination of the implications of the US Food and Drug Administration's (FDA's) new integrated review template for RI. We constructed a database, designated bZIPDB, containing information on 49 human bZIP TFs, by means of automated literature collection and manual curation. To support the release of the Q4 Regulatory Focus Article Series, Regulatory Intelligence and Policy: Shaping the Global Landscape, RAPS hosted a lively discussion on Regulatory Exchange with three regulatory intelligence experts, Meredith Brown-Tuttle, Matt Medlin and Kirsten Messmer. Labeling Process and Materials. Compliance in Every Market. The global regulatory environment is monitored by this team for evolving trends along with the creation of policies in agreement with the guidelines of the regulatory agency and investigates standards and precedents to inform anticipatory input and intelligence to enable robust, proactive regulatory strategies (Akhigbe et al., 2017). We span the globe, covering more than 110 countries, regions and international organizations around the world. Quickly find information on chemical substances and regulations. Regulatory data is information that must be provided by a company to a regulatory agency. — all in the proper formats. 35-38. Cortellis Regulatory Intelligence gives you access to: 3K+ regulatory summaries for each stage of the drug development lifecycle. Information Database for Regulatory Intelligence: A Review. Pgs. The data is then cultivated into regulatory intelligence and synthesized into actionable items for the company, such as adjusting compliance procedures to avoid enforcement fines. Our database shows that it is possible to define the threshold for categorizing a technology as AI/ML based and also, that there is a need from regulatory agencies to create their own databases. We've seen digital health technology and AI change the . Global Regulatory Information Database - How is Global Regulatory Information Database abbreviated? The source of the data comes from the required regulatory forms filed for supervising purposes. Regulatory precedence, industry practices, regulatory agency opinions, and competitor . Regulatory Information Management (RIM) Calyx RIM is a proven, cloud-based regulatory information system for optimizing regulatory publishing, submissions, and registrations. The Medical Device Regulatory Intelligence is a multi-dimensional activity and includes monitoring of Regulatory environment, Procedural and competitor intelligence. Strategically, global regulatory affairs within organizations have to support . Regulatory Intelligence Database. Call Us. Freyr IMPACT, an innovative Cloud-hosted Regulatory Intelligence software/tool, offers Regulatory Intelligence reporting & tracking support. Usually part of a biopharmaceutical company's RA department, it broadens the traditional regulatory affairs function beyond preparing and submitting applications to the FDA and other regulatory agencies across the globe. UL's ChemADVISOR™ Regulatory Database formerly known as LOLI (Lists of Lists), helps you gain regulatory intelligence - containing over 7,100 regulatory lists from over 130 countries around the world to guide you in world-class chemical safety, product management, and environmental stewardship, including Safety Data Sheet . Indexes list bibliographic information about the article such as: article title, author, journal name, volume, issue, page number, date and subject headings or descriptors. If a country you are looking for is not included in ClinRegs, consider the following . GRID - Global Regulatory Information Database. Countries are included based on NIAID's international clinical research priorities. Tune in for a demonstration of three unique prototypes, followed by a Q&A on the implications of this type of work across the public service and how artificial intelligence (AI) and machine learning could play a bigger role in our work moving forward. key Regulatory information and data has been - and still is to a large extent - a significant industry challenge. Regulatory Intelligence brochure. Regulatory Information Management Systems/Software, or RIMS, are platforms that have emerged to assist pharmaceutical companies and medical device manufacturers in submitting products for regulatory review. What is Regulatory Intelligence? As the need for impactful and targeted regulatory intelligence becomes more and more pressing for the Life Sciences industry, it won't be enough to simply gather data. AtcisDB provides a comprehensive resource for the scientific community working with gene regulatory information of Arabidopsis thaliana.AtcisDB consists of a searchable relational database, which includes many different data types, such as transcription factor binding site information, promoter sequence and related annotations. The experts , who were all authors in the series, offered their perspectives on the importance of regulatory . Please see the Federal Reserve Bank of Chicago website for more information. that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. Regulatory Intelligence: How AI will change regulatory operations . 8K+ analyst-written intelligence reports. Overview. Keep your product data in control. This requires systematic harvesting of information, followed by effective filtering, analysis and interpretations to deliver robust regulatory strategy. bZIPDB aims to provide public data required for deciphering the gene regulatory network of the human bZIP family, e.g., evaluation or reference information for the identification of regulatory modules. ViSU™ is a cloud based Regulatory platform with modular approach designed specifically to enable global users to access and manage Regulatory Data (Product Master, Registrations, Tracking), Dossiers/Tech Files (Submission planning, building, publishing /QC automation & life cycle management), Document Authoring (Structured content or Word), HA/NB correspondence, Requests/Obligations . Our platform is the main source of data on the e-cig sector for manufacturers, retailers, regulators and . The company has launched a platform that they . We could not find any details on how CUBE's RegTech platform analysed regulatory information from their data lake to prompt compliance actions to their clients or any evidence of robust case studies. Legal Periodicals and Indexes. Global Regulatory Information Database listed as GRID. Table 3. This regulatory tool consolidates all of our global regulatory Live Alerts, collected in Excel database format, allowing you to filter information by date, region, country . This includes all submission content, data, messages, notices, etc. 2022 Worldwide CBD Regulatory Landscape Database: Includes Information on Hemp Cultivation, Processing, Flowers, Extracts, Food, Cosmetics, Vaping, Pet Foods, and Imports/Exports News provided by . The process is driven by business needs and linked to decisions and actions." We've seen digital health technology and AI change the . Search for FDA Guidance Documents RegDesk saves time and reduces risk by providing the most comprehensive, up-to-date regulatory intelligence on the web. Also included were articles on the importance a global unique . Compliance.ai is a Silicon Valley startup founded in 2016 with around 26 employees. Regulatory Intelligence helps your organization anticipate and manage global regulatory developments in a single solution, removing the burden of having to manually track multiple sources of regulatory information. Insights & Regulatory Analysis. RDC's proprietary Global Regulatory Information Database (GRID) helps companies assess counterparties through a lens of more than 60 risk types by examining over 120,000 global sources . Regulatory Information Databases: A review. CSPS Data Demo Week: Regulatory Artificial Intelligence. There is more to RI than keeping up with the latest regulations and guidelines. Uniquely combining innovative cloud technology with decades of regulatory and user experience . Vada A. Perkins (CAPT, ret.) Global market and regulatory analysis of heated tobacco and nicotine products in the alternative tobacco industry worldwide. Contains five databases providing accounting data for bank holding companies, commercial banks, savings banks, and savings and loans institutions. is a former FDA Senior Advisor for Regulatory Science and a recognized global regulatory policy & intelligence expert with thought leadership in the application of technology, international data standards, and data management in the development, interpretation, and . The Arabidopsis Gene Regulatory Information Server. Every journey begins with a single step. The process of gathering, analyzing, and then distributing regulatory intelligence is very . Information and content is stored once and can be accessed globally. we've seen AI have tremendous potential and impact on the efficient analysis of complex data sets to drive drug development. Our consultants will work with you to map key risk areas and get rid of the white noise and repetitive processes so internal staff can focus on decision-making and implementation. Data Sheet. Whether it is to generate assumptions for strategy and planning, identifying new opportunities or to assess the viability of potential new markets, VIXIO Data Hub gives users access to over 3.5 million data points for over 140+ jurisdictions. we've seen AI have tremendous potential and impact on the efficient analysis of complex data sets to drive drug development. All the stories from the TobaccoIntelligence regulatory Live Alerts in one user-friendly database, updated every month. Appian provides a more comprehensive end-to-end review and management of the labeling process throughout the lifecycle of a pharmaceutical or medical device. Regulatory Intelligence reduces the potential room for errors and vulnerability within your organization by providing information that has been stringently tracked, monitored, and analyzed, helping you manage and mitigate risk. And that's the missing piece of the puzzle . Toll-Free only +1 866 267 4479. Protecting consumers is the main rationale offered by governments looking to regulate economic activity, and they try to do so in two primary ways. NIS Regulatory Intelligence Database contains links to all regulations and guidelines, submission document templates, data on regulatory bodies. increase transparency, regulatory intelligence becomes more important to make sense of the information. Vada Perkins Head, Regulatory Intelligence, Director, Regulatory Policy & Intelligence Bayer. Get regulatory tracking, quantitative data and in-depth market analysis of heated tobacco, snus, nicotine pouches, oral tobacco, and new alternative-tobacco products with our platform. Capco CRI's Data Feed offers uniquely tailored compliance updates sourced from almost 1,000 primary legislative and regulatory bodies and covering over 100 topic areas. Contact Us. . EY regulatory technology (RegTech) brief 2019 4 Visual analytics Changes in the CFO agenda have resulted in the need to With the increasing study of human diseases and biological processes, information in human H3K27ac ChIP-seq, ATAC-seq and DNase-seq datasets is accumulating rapidly, resulting in an urgent need to collect and process data to identify transcriptional regulatory regions . The most important step to introducing your medical products to new markets is initial intelligence gathering. Play. ECigIntelligence, e-cigarette industry research and trends. Table 5. Date: April 29, 2021. The WWW as a hierarchical regulatory intelligence database IQVIA's AI-enabled RIM Smart system seamlessly connects regulatory, safety and quality data and integrates with your existing tools so the right users can rapidly access the right information at the right time. Successfully manage and evaluate regulatory intelligence. Combining our unrivalled knowledge and deep understanding of the sector, we provide critical and timely intelligence that helps you make sense of what's happened and what it means for your organisation. Business Intelligence: For strategic and operational reporting needs, it is essential to have visibility across regulatory functions, interdependent processes, and increased interactions with internal and external stakeholders as well as regional and local affiliates. The Cortellis suite of solutions helps research and development, portfolio strategy and business development, and regulatory and compliance professionals gather and assess . The VIXIO Data Hub allows users to quickly understand and manipulate in-depth market insight into the global gambling industry. Regulatory data and information Fund related regulatory documents and templates. In general regulatory intelligence is the monitoring, gathering and analyzing of publicly available and experience based regulatory information to develop a strategy for time - and cost-efficient drug development. Freyr, with expertise in global Medical Device Regulatory landscapes, brings forth the best of information on Health Authorities regulations and regional market scenarios. With Tarius you have a dedicated platform that gives you ready access to the . An example of this is data protection laws, which resulted from an increased level of personal information being stored by organizations due to advances in medical care, telecommunications, transportation systems and financial transfers . (NIS) around the world. Comparatively, human identification of new molecules has been slow and far less effective. This ensures data integrity as you coordinate product release processes across your stakeholders. Our in-house team of experts bring you the latest insights affecting the payments industry. S&P DJI Methodology & Regulatory Database Section 871(m) Information Through the 871(m) fact sheets, S&P DJI provides its clients information necessary to make its independent determination whether a given Index is a "qualified index" for the purposes of U.S. Internal Revenue Service Code Section 871(m) . Execute a more successful labeling management process. Data Science and Artificial Intelligence Regulatory Applications Workshops Overview: A series of three public workshops are planned to provide a forum for the U.S. NRC, nuclear industry and stakeholders to discuss the state of knowledge and research activities related to data science and artificial intelligence and their application in the nuclear industry. global regulatory comparison tables with links to original source documents, including FDA 483 forms, approvals, inspection reports and submissions. Description. Regulatory Intelligence Systems for The Life Sciences Industry. Supporting a data-driven approach to regulatory intelligence. Learn more It is Global Regulatory Information Database. Over many years, VISTAAR has built deep data sets . Regulatory Intelligence Combining this with: 1) the ever increasing complexity of regulations and product portfolios, 2) growing demand for data The key to managing regulatory information as a corporate asset is to transform the Regulatory Information Management (RIM) landscape with end-to-end capabilities or solutions that are fully integrated, allowing for seamless transfer of data and reducing data quality issues due to manual handoffs or duplicate data entry into siloed applications. Analysis of data to create actionable regulatory information create advantage . Regulatory intelligence portal effectively monitors, collects & updates information by analysing regulations, guidance, policy and legislation. We span the globe, covering more than 100 countries, regions and international organizations around the world. Regulatory Intelligence for free. Regulatory documents and templates Expand all panels European PRIIPs Template (EPT) The European PRIIPs Template (EPT) is an initiative driven by European Working Group (EWG) - EFAMA in collaboration with Insurance Europe with the aim to standardize the data for . ViSU™ is a cloud based End-to- End Regulatory Information Management (RIM) platform designed specifically for the medical device industry enabling global users to access and manage Regulatory Data (Product Master, Registrations, Tracking), Dossiers/Tech Files (Submission planning, building & life cycle), HA/NB correspondence, Obligations . Compliance.ai. However, its become increasingly difficult to find, integrate and analyze the key data your teams need to make critical decisions and get your products to patients faster. VISTAAR provides Global Regulatory, Clinical and Compliance Requirements to Biopharma, Devices, Consumer Health, Cosmetics, and Digital Health. With MasterControl, you can closely manage all documents for each global agency. With increased complexity and demand for transparency, the future points to new . Streamline and optimize your regulatory affairs processes. Regulatory Intelligence (RI) is the act of gathering and analyzing regulatory information for impact or changes in laws, regulations, directives, guidance documents, etc. The Bula Team tracks laws, bills, regulations, sub-regulations, rules and policies in all 50 states, D.C. and federal, and notifies clients with actionable intelligence of any changes that could . Regulatory Information Management Systems, RIMS, enable life sciences companies to manage, control and drive the process of bringing new products to market, keep existing products on market and manage interactions with authorities. Tarius supports your regulatory intelligence activities by providing access in one place to global regulatory information for the healthcare industry on Human Drugs, Biologics, Medical Devices, and IVDs. Information about the CLIA Database, Clinical Laboratory Improvement Amendments - Currently Waived Analytes, and the Over The Counter Database. The ability to filter and digest it will become a greater priority. "Regulatory intelligence is the act of processing targeted information and data from multiple sources, analysing the data in its relevant context and generating a meaningful output - e.g. Using cloud-based technology combined with advanced analytics--including artificial intelligence and machine learning -- we are bringing together global regulatory intelligence, safety data, product quality information and . • Dependency on data sourcing initiatives, such as data warehouses and data lakes, are a key reason for organizations to delay report automation activities. Drug developers are increasingly applying data-driven analysis of the actions of regulatory agencies to gain insights into their . Topic Paragraphs. Reliable data quality: Create a single source of truth for your product portfolio by capturing timely and accurate information. Improving efficiency, transparency, and predictability of regulatory affairs strategy depends on effective collection and dissemination of regulatory intelligence. Comparatively, human identification of new molecules has been slow and far less effective. Check out the top tools to track the ever-shifting landscape for regulatory intelligence and compliance . We're pleased to speak with you during our business hours. Focus, October. 34-37. How Does Regulatory Data Work? Of regulatory and compliance professionals gather and assess, updated every month than keeping with! The process of gathering, analyzing, and regulatory analysis, legal tracking and actionable data insights find the is! 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