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Limited Time Offer | 11-in-1 Bundle | CPD QS Certified | 115 CPD Points | Get Hard Copy + PDF Certificates + Transcript + Student ID Card worth £160 as a Gift | Lifetime Access | Enrol Now

11-in-1 Premium Bundle | CPD QS Certified | 110 CPD Points | Free Hardcopy + PDF Certificate + Exam | Lifetime Access | Tutor Support | Enrol Today

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.

"The future belongs to those who prepare for it today." - Malcolm X. Embrace the evolving digital landscape with our comprehensive IT (Information Technology) Support with Cyber Security & Data Protection Training bundle course. Delve into various topics, from IT (Information Technology) Support Technician Training to GDPR Data Protection Level 5, to fortify your knowledge and understanding of the technological world. Equip yourself with the essential tools to excel in IT (Information Technology) Support, asset management, and computer building. Our curriculum covers crucial subjects such as Electronic & Electrical Devices Maintenance, Cyber Security Incident Handling and Response, and Data Center Training Essentials to ensure your readiness for a rewarding IT and cyber security career. Stay ahead of the curve by mastering essential software and platforms through our Level 2 Microsoft Office Essentials and Complete Windows 10 Troubleshooting for IT Help Desk courses. Additionally, our Cloud Computing / CompTIA Cloud+ (CV0-002) module will provide insights into the ever-expanding world of cloud technology. Finally, Enrol in our IT (Information Technology) Support with Cyber Security & Data Protection Training bundle course today and secure your future in the rapidly growing tech industry. This IT (Information Technology) Support with Cyber Security & Data Protection Training Bundle Consists of the following Premium courses: Course 01: IT (Information Technology) Support Technician Training Course 02: IT Asset Department Course 03: Learning Computers and Internet Level 2 Course 04: Building Your Own Computer Course 05: Electronic & Electrical Devices Maintenance Course 06: Cyber Security Incident Handling and Incident Response Course 07: GDPR Data Protection Level 5 Course 08: Data Center Training Essentials: General Introduction Course 09: Complete Windows 10 Troubleshooting for IT HelpDesk Course 10: Cloud Computing / CompTIA Cloud+ (CV0-002) Course 11: Level 2 Microsoft Office Essentials Learning outcomes: Gain proficiency in IT (Information Technology) Support and troubleshooting techniques. Understand the workings of an IT asset department. Enhance your knowledge of computers and the Internet. Learn how to build and maintain your computer. Develop aptitudes in electronic and electrical device maintenance. Tackle cyber security incidents with effective handling and response strategies. Comprehend the nuances of GDPR data protection. Familiarise yourself with data centre essentials and cloud computing. Our IT (Information Technology) Support with Cyber Security & Data Protection Training bundle course offers a diverse and in-depth exploration of the many facets of the IT and cyber security fields. From IT (Information Technology) Support technician training to mastering the intricacies of data protection, this comprehensive course bundle encompasses a wide range of essential topics to prepare you for success in the ever-changing tech landscape. Whether you're looking to advance your career in IT (Information Technology) Support, enhance your knowledge of data protection, or dive into the world of cloud computing, this multifaceted course has you covered. Equip yourself with the tools and knowledge necessary to excel in the digital domain and stay ahead of the curve in this fast-paced industry. Course Curriculum: IT (Information Technology) Support Technician Training Section 01: How People Use Computers Section 02: System Hardware Section 03: Device Ports and Peripherals Section 04: Data Storage and Sharing Section 05: Understanding Operating Systems Section 06: Setting Up and Configuring a PC Section 07: Setting Up and Configuring a Mobile Device Section 08: Managing Files Section 09: Using and Managing Application Software Section 10: Configuring Network and Internet Connectivity Section 11: IT Security Threat Mitigation Section 12: Computer Maintenance and Management Section 13: IT Troubleshooting Section 14: Understanding Databases Section 15: Developing and Implementing Software CPD 110 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Aspiring IT (Information Technology) Support technicians. Individuals interested in cyber security and data protection. Those seeking to build and maintain their computers. Professionals aiming to work in IT asset management. Individuals looking to expand their Microsoft Office and Windows 10 expertise. Anyone pursuing a career in cloud computing. Requirements This IT (Information Technology) Support with Cyber Security & Data Protection Training course has been designed to be fully compatible with tablets and smartphones. Career path IT (Information Technology) Support Technician (Salary range: £18,000 - £35,000) IT Asset Manager (Salary range: £25,000 - £45,000) Computer Repair Specialist (Salary range: £18,000 - £30,000) Cyber Security Analyst (Salary range: £25,000 - £60,000) Data Protection Officer (Salary range: £30,000 - £60,000) Data Center Technician (Salary range: £20,000 - £40,000) Cloud Computing Specialist (Salary range: £30,000 - £70,000) Certificates Certificate of completion Digital certificate - Included Certificate of completion Hard copy certificate - £10 You will get the Hard Copy certificate for the IT (Information Technology) Support Technician Training course absolutely Free! Other Hard Copy certificates are available for £10 each. Please Note: The delivery charge inside the UK is £3.99, and the international students must pay a £9.99 shipping cost.

Modern designing techniques in the building and architectural fields include the usage of CAD (computer-aided design). Enrol in our CAD course to discover how to use computer-aided design fundamentals. To create blueprints and models, numerous industries use CAD software. It may be used to create exact measurements for 2D drawings and 3D models. Engineering, industrial design, architecture, and product design are just a few of the many sectors that regularly use CAD. Through this CAD training program, you will discover the fundamentals of Using CAD (computer-aided design), AutoCAD programming, shapes, and modelling. The curriculum will demonstrate the fundamentals of AutoCAD, T-Flex CAD, and freeCAD. Additionally, it will acquaint you with 2D and 3D forms, enhancing your viewpoint when constructing designs. The subjects of geometry and modelling, extrusion, rotation, grids, and regular polygons are all covered in this module. This Bundle Consists of the following Premium courses: Course 01: Level 5 CAD Designer Training Course 02: CAD Design Course: Assemblies, Modelling And Civil Drawings Course 03: Autocad Electrical Design Course 04: Solidworks Foundation Training Course 05: AutoCAD VBA Programming - Beginner course Course 06: AutoCAD to Excel - VBA Programming Hands-On! Course 07: Learn AutoCAD Programming using VB.NET - Hands-On! Course 08: AutoCAD Programming Using C#.NET Level 7 Course 09: Architectural Studies Course 10: Interior Design Professional Diploma Course 11:Decision Making and Critical Thinking The curriculum of CAD Training Bundle Course 01: Level 5 CAD Designer Training CAD Module 01: Introduction CAD Module 02: CAD Designer Career in the United Kingdom CAD Module 03: Basics for CAD Design - Part 1 CAD Module 04: Basics for CAD Design - Part 2 CAD Module 05: 2D Shape Using CAD CAD Module 06: 3D Shape Using CAD CAD Module 07: Geometry and Modelling CAD Module 08: Assemblies in Design CAD Module 09: Extrusion and Rotations CAD Module 10: Blending Operations CAD Module 11: Grids and Regular Polygons CAD Module 12: Parameters in Civil Drawings CAD Module 13: Introduction to AutoCAD CAD Module 14: Introduction to T-Flex CAD CAD Module 15: Introduction to SolidWorks CAD Module 16: Introduction to FreeCAD CPD 120 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Anyone from any background can enrol in this bundle. Requirements This course has been designed to be fully compatible with tablets and smartphones. Career path Successful completion of this CAD course paves the way for a series of exciting and thriving job opportunities, such as - CAD Designer Compounder Coater Technician The average salary for these positions in the UK is £25k - £45k annually. Certificates Certificate of completion Hard copy certificate - Included You will get the Hard Copy certificate for the title course (Level 5 CAD Designer Training) absolutely Free! Other Hard Copy certificates are available for £10 each. Please Note: The delivery charge inside the UK is £3.99, and the international students must pay a £9.99 shipping cost. Certificate of completion Digital certificate - Included