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A 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ‘stand-alone’ NDA in that some of the data on which the applicant relies to demonstrate safety and efficacy have been obtained from publicly available sources rather than from the applicant’s own studies. The applicant typically proposes to market a drug that is based on an approved reference product but modified in its formulation or uses. A 505(b)(2) NDA also differs from an Abbreviated New Drug Application (ANDA) for approval of a generic drug in that the applicant’s product need not be a duplicate of the reference listed drug. The 505(b)(2) pathway may be said to lie part-way between the ‘stand-alone’ NDA and generics pathways, offering a unique combination of advantages to developers. It facilitates the modification of drugs to address unmet medical needs. The 505(b)(2) application pathway accounts for about half of all new drug approvals in the USA.
This interactive course will help you gain a solid understanding of Protractor. You will get hands-on experience in designing Protractor frameworks for automating Angular applications. You will also understand the role of modern technologies, such as JavaScript, TypeScript, Node.js, and Jasmine, in designing the frameworks.
A comprehensive and detailed course containing premium beginner, intermediate, and advanced level content. Start with the fundamentals and build a strong foundation before gradually studying Excel 2021's advanced features, formulae, and functions that will help you become a master.
Advanced Professional Certificate Courses These are short online certificate courses of a more advanced nature designed to help you develop professionally and achieve your career goals, while you earn a professional certificate which qualifies you for the appropriate continuous professional development (CPD). Advanced Professional Certificate in Anti Money Laundering This course offers a comprehensive understanding of the Concepts, Tools, Strategies and Procedures under relevant Laws and Regulations of an effective Anti Money Laundering programme. The course introduces the concept of money laundering and differentiates it from other forms of financial crimes so that the learner can effectively manage the financial transactions and be alerted of any suspicious activity. The course also equips the learner to understand different ways people launder money, strategies that the regulators use to counter the same, and a detailed compliance regime. Course Details After the successful completion of this lecture, you will be able to learn about the following;01. Money Laundering Concepts, Methods and Impact; Understand the concept and evolution of money laundering. Identify the three stages of money laundering. Understand different methods used in money laundering. Measure the impact of money laundering on economic growth. 02. National and International Regulatory Landscape of AML; Understand the structure of the UK anti-money laundering system. Identify the main rules and regulations governing the UK anti-money laundering system. Understand the role of the financial conduct authority and other UK regulatory bodies. Understand the structure of the US anti-money laundering system. Identify the main rules and regulations governing the US anti-money laundering system. Understand the role of the FinCEN and other US regulatory bodies. Define the global framework of anti-money laundering. Reflect on the European Union and the United Nations anti-money laundering efforts. Understand the role of the Financial Action Task Force. 03. Anti-money Laundering Strategies And Tools; Understand the role of anti-money laundering strategies. Determine the most influential entities in shaping anti-money laundering strategies. Understand the principle of a risk-based approach. Identify common anti-money laundering program deficiencies. Identify the foundational elements of anti-money laundering programs. Determine various tools used to reduce money laundering risks. 04. Anti-money Laundering Cases; Understand landmark anti-money laundering cases. Reflect on the consequences of a failed anti-money laundering strategy. Reflect on the consequences of a successful anti-money laundering strategy. Identify major money laundering red flags. Accreditation All MSBM courses are accredited by the relevant partners and awarding bodies. Please refer to MSBM accreditation in about us for more details. Entry Requirements There are no strict entry requirements for this course. Work experience will be added advantage to understanding the content of the course. The certificate is designed to enhance the knowledge of the learner in the field. This certificate is for everyone eager to know more and gets updated on current ideas in the respective field. We recommend this certificate for the following audience. CEO, Director, Manager, Supervisor AML Compliant Manager/Executive/Officer Head of Compliance Head of Audit Corporate Risk Manager AML Policy Advisory Analyst
Preparing for the CISSP Certification Exam? Then this course is for you. In this course, you will learn more effective CISSP study techniques, exam hacks, formats, and strategies, as well as how to correctly respond to exam questions.
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The insights gained from data analysis are only truly valuable when you can be clearly expressed to other people – bosses, colleagues, clients, customers, or other stakeholders. In this workshop you’ll learn how to turn raw qualitative or quantitative data into a clear visual story through infographics and data visualization. We'll discuss the key principles for planning an effective visual, look at examples of best (and worst) practice, and learn repeatable and practical design techniques for enhancing the story. We'll also give you an overview of useful tools that will help you turn your idea into a finished infographic or data visualization. You could be conjuring up eye-catching slide decks, building effective reports and dashboards, pitching to investors, or presenting persuasive data to your most important customers. This is a fully interactive online workshop, so be prepared to join discussions and get hands on with building your own visualisations. Takeaways Be able to evaluate the elements that make an infographic or visualization effective. Learn quick and repeatable visual tricks for ensuring infographics convey a clear message. Understand how to tailor your approach to different audiences and context. Discover a bunch of free tools and resources to help you build your own visualizations. Understand how online, interactive visualizations work and how to create them. Delivery We deliver our courses over Zoom, to maximise flexibility. The training can be delivered in a single day, or across multiple sessions. All of our courses are live and interactive – every session includes a mix of formal tuition and hands-on exercises. To ensure this is possible, the number of attendees is capped at 16 people. Tutor Alan Rutter is the founder of Fire Plus Algebra. He is a specialist in communicating complex subjects through data visualisation, writing and design. He teaches for General Assembly and runs in-house training for public sector clients including the Home Office, the Department of Transport, the Biotechnology and Biological Sciences Research Council, the Health Foundation, and numerous local government and emergency services teams. He previously worked with Guardian Masterclasses on curating and delivering new course strands, including developing and teaching their B2B data visualisation courses. He oversaw the iPad edition launches of Wired, GQ, Vanity Fair and Vogue in the UK, and has worked with Condé Nast International as product owner on a bespoke digital asset management system for their 11 global markets. Testimonials "Just to say what a great course this was. I have made my first report employing some of the ideas and tools you showed us – to rapturous responses! The next actions are clear for all and they all understood it! Thank you for helping me to organise my data and thoughts, showing how to present the key message up front, and how to keep it simple and focused. Gearing up for another report now!" Kay Anderson | Head of Finance | Mima "We have been using Tableau to display data for some time but knew we could do more to engage our end users. Alan’s training gave us a framework to start thinking about what we wanted to achieve with our visualisations and analysis, and some great tips on how to display information for maximum impact. Alan was an engaging trainer and we found the workshops very energising." Ellen Austin | Senior Data Analyst | London School of Economics