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.
Create a well-structured pathway to optimized content by understanding how information architecture applies to user experience design.
Courses are aimed at supporting engineering apprentices and T-Level learners who are taking their first steps into the workplace environment, providing basic information in a range of key health and safety hazards in the engineering workplace. Modules allow an understanding of the concept of hazard and risk, a learner's own and their employer's legal obligations, the types and nature of safety hazards and how to avoid the hazard or reduce its risk of causing harm and how to respond to emergency situations. In addition to common mandatory health and safety modules, learners will also choose modules relevant to their occupational pathway.
Courses are aimed at supporting engineering apprentices and T-Level learners who are taking their first steps into the workplace environment, providing basic information in a range of key health and safety hazards in the engineering workplace. Modules allow an understanding of the concept of hazard and risk, a learner's own and their employer's legal obligations, the types and nature of safety hazards and how to avoid the hazard or reduce its risk of causing harm and how to respond to emergency situations. In addition to common mandatory health and safety modules, learners will also choose modules relevant to their occupational pathway.
Blue CSCS Card Level 2 NVQ Diploma in Construction Operations and Civil Engineering Services - Highways Maintenance Induction - As soon as you register you will be given a dedicated assessor. They will arrange an induction and together with your assessor, you will get to decide on the pathway which best proves your competency. The induction is used to plan out how you will gather the relevant evidence to complete the course. During the course - The assessor will work with you to build a portfolio of evidence that allows you to showcase your knowledge, skills and experience. The assessor will also regularly review and provide you with feedback. This will allow you to keep on track to progress quickly. You will be assessed through various methods such as observations, written questions, evidence generated from the workplace, professional discussion, and witness testimonials. On completion - Once all feedback has been agreed, the Internal Quality Assurer will review your portfolio and in agreement with your assessor the certificate will be applied for. To download our PDF for this course then please click here.
Duration 2 Days 12 CPD hours This course is intended for The primary audience for this course is any IT, facilities or data centre professional, consultant and/or those who work in network cabling system design, implementation and operation. Overview With few exceptions, enterprises today rely on IT for the delivery of business-critical services - often directly to the end consumer. It is therefore vital that the mission-critical data centre is designed, maintained and operated with high-availability and efficiency in mind. Among all the facilities, network cabling is the foundation for the network and one of the major contributors to the availability of the data center.CNCDP© is a 2-day course designed to expose participants to in-depth knowledge in designing and installing the data network cabling system which includes key subject matters such as; technical standards, designing of different cabling sub-systems, calculation of material requirements, architecture, installation, testing and acceptance. Introduction to Structured Cabling System (SCS) Brief history of SCS Basic copper and fibre transmission Copper and fibre cabling Single and multimode fibre Step/graded index multimode fibre Difference between Commercial Wiring and data centre cabling Development of standards Role of standards ANSI/TIA 568 standard Common standards The new usage of cabling to support Smart building Horizontal and Administration - Commercial Building Standard diagram recap: ANSI/TIA-568 Functional elements and example Scenario A: Determine the number of work areas Scenario B: Determine the number of user locations Zone wiring Administration: Interconnect and cross-connect Angled and flat panels Creating a cabling schematic design Convert schematic into physical layout Calculating the material list Horizontal and Administration - Data Centre Standard diagram recap: TIA-942 Basic/Reduced/Typical data centre setup Traditional 3 layers network design/ Spine and Leaf network design Select termination hardware Administration design ToR/EoR/Spine & Leaf cabling design Network and cabling resiliency Create cabling schematic design for ToR/EoR Convert into patch panel/rack layout Calculate the material list for ToR/EoR Building Backbone - Commercial Building Backbone diagram Calculate the copper backbone requirements per Telecom Room (TR) Calculate the fibre backbone requirements per Telecom Room Summarize the building backbone requirements Recognised cables Backbone Patch panels The maximum backbone distances Create cabling schematic design Converting the schematic design into patch panel/ rack layout Building Backbone - Data Centre TIA-942 based backbone topology TIA-942 backbone requirements Recognised backbone cable ToR/EoR/Spine and Leaf Backbone distance estimation Resiliency of backbone cable routes Creating cabling schematic design Converting the schematic design into patch panel/ rack layout Field and Fusion Termination for fibre connectors Pre-terminated fibre trunk and copper cables Architectural Considerations ANSI/TIA569-D Cable pathway and spaces Common requirements for the rooms Definition of the rooms Entrance Room/Demarcation Ceiling and floor pathways types Cable trays/basket/ladder/conduit Inner duct/sleeve/slot Calculating of pathway size Cable run best practices Cable management/AIM Grounding and bonding Separation distance requirements for copper cabling to power cabling Fire stopping Fire rated barrier Fire rated jacket cable Campus / Outdoor Backbone Common campus cable installation and cable types : Aerial cable / Direct-buried / Underground in-conduit Outdoor cable installation planning Lightning / surge protection Approved ground for surge protector Creating a schematic diagram Converting a schematic into a physical layout Site Inspection and Testing Visual site inspection notes Installation common issues Copper testing standard Permanent link / Channel / Patch cord / MPTL testing configuration Fibre connectors Fibre testing standard Tier 1 & 2 certification Fibre link definition Fibre testing steps Fibre inspection and cleaning Calibrating the test sets - 3 methods Setting up mandrel for testing Fibre loss budget calculation G.657 Bend insensitive fibre Optical Time-Domain Reflectometer (OTDR) Exam - Certified Network Cabling Design Professional (CNCDP©) The exam is a 60-minute closed book exam, with 40 multiple-choice questions. The candidate requires a minimum of 27 correct answers to pass the exam. Additional course details: Nexus Humans Certified Network Cabling Design Professional (CNCDP) training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the Certified Network Cabling Design Professional (CNCDP) course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.
Preparing for Digital Transformation Organizations today must keep pace with changing technology to stay abreast of the market demand. Keeping pace means a transformation of the entire organization into the digital age. This workshop presents the challenges, benefits, and pitfalls of digital transformation and how it will affect you, and how you can be better prepared and positioned for the upcoming digital transformation. The goal of this course is to enable you to become knowledgeable about the technologies behind a digital transformation in your organization and the driving forces compelling such a transformation. You will learn how to become engaged in the processes of transforming your organization digitally to meet with the growing demands of customers and clients What you will Learn Describe the impact that digital is making on the economy and on customer expectations Examine the nature and drivers of the digital transformation Evaluate new technologies such as Blockchain, Big Data, Artificial Intelligence, and other technologies and see how they work to bring about digital transformation Assess the impact of digital technologies on the current roles and positions in the organization Discuss both the demand that customers have for digital technologies and the impact the digital technologies have on the customer and its relationship with the organization Recognize the new technology trends in the digital transformation and what they mean to the future of the organization Identify how digital transformation will affect all roles and how to be prepared for the upcoming and continuing digital transformation Foundation Concepts Digital transformation versus automation Driving forces behind the digital transformation Learning from digital transformation successes Digital Transformation and Customer Orientation The Digital Customer Customer touch points and the customer journey Omnichannel concept Transform to the customer Digital Technologies and the Organization Relationship Management Big Data: The Basis for it All The Human Factor in Digital Transformations Risks of Digital Transformation Technology Trends Data and Business Analytics Other Major Trends Preview of Coming Attractions Pathway to Digital Transformation
See how the NADIS parasite and vaccination planners can help you deliver the Animal Health and Welfare Pathway for flocks and herds under your care
Asbestos Awareness training is a legal requirement for any worker who may encounter asbestos during their work. Modules will provide relevant and detailed knowledge about the dangers of asbestos, the products that contain asbestos, what it looks like, where it may have been used and the practical steps that can be taken to reduce their risk of exposure. In addition to common mandatory modules, learners will also choose a selection of modules relevant to their occupational pathway.
Asbestos Awareness training is a legal requirement for any worker who may encounter asbestos during their work. Modules will provide relevant and detailed knowledge about the dangers of asbestos, the products that contain asbestos, what it looks like, where it may have been used and the practical steps that can be taken to reduce their risk of exposure. In addition to common mandatory modules, learners will also choose a selection of modules relevant to their occupational pathway.