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.
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Either you’ve been in marketing for years or you’re just starting out in this fascinating field, you can be sure that you’ll learn something new in this course.Learn from the best in the marketing field, from our marketing expert who will share his knowledge and experience with you, and gain a lot from it.Join our platform today and maximize revenue with new skills!Dolores AbernathyDigital marketing expert
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Course 02: Secretarial & Shorthand Acquire advanced shorthand skills for rapid note-taking and transcription. Develop organizational skills crucial for effective secretarial tasks. Learn the art of multitasking and time management in a secretarial role. Course 03: Performance Management Understand key concepts and strategies for effective performance management. Learn to set SMART goals and objectives for individuals and teams. Develop skills in providing constructive feedback and conducting performance appraisals. Course 04: Team Management Advanced Training Acquire advanced team-building techniques to enhance collaboration. Learn effective delegation strategies for optimal team performance. Develop conflict resolution skills to maintain a positive team environment. Course 05: Modern Business Etiquette Understand and apply modern business etiquette in professional settings. Learn effective communication and networking skills. 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Learn about document version control and efficient data handling. Understand best practices for document security and compliance. Course 14: Document Control and Workflow Management Gain expertise in document control processes and procedures. Learn to design and optimize workflow management systems. Develop skills in ensuring document accuracy, completeness, and compliance. Course 15: Touch Typing Training Develop touch typing skills for improved typing speed and accuracy. Master keyboarding techniques to enhance overall productivity. Increase efficiency in data entry and document creation. Course 16: Email Writing Training Enhance email writing skills for clarity and professionalism. Learn effective email etiquette and communication strategies. Develop strategies for managing and organizing email correspondence. Course 17: Public Speaking Masterclass Master the art of public speaking with confidence and poise. Learn effective techniques for engaging and captivating an audience. Develop strategies for overcoming nervousness and handling Q&A sessions. Course 18: Corporate Receptionist Acquire skills in providing excellent front desk and reception services. Develop telephone etiquette and customer service proficiency. Master organizational and multitasking skills essential for reception roles. Course 19: Corporate Risk And Crisis Management Understand principles of risk assessment and crisis management. Learn to develop and implement effective risk mitigation strategies. Acquire skills in crisis communication and decision-making. Course 20: Cross-Cultural Awareness Course Develop cultural intelligence for effective communication across cultures. Learn to navigate cultural nuances and avoid cultural misunderstandings. Enhance global collaboration and adaptability in diverse workplaces. Course 21: Equality, Diversity and Discrimination Gain a deep understanding of equality and diversity principles. Develop strategies for promoting inclusivity and preventing discrimination. Learn about legal frameworks and responsibilities related to equality and diversity. Course 22: Coaching & Mentoring Diploma Acquire coaching and mentoring skills for professional development. Learn effective techniques for goal setting and skill enhancement. Develop strategies for providing constructive feedback and support. Course 23: Presentation Skills: Engage Your Listeners Master techniques for creating engaging and effective presentations. Develop skills in public speaking and audience engagement. Learn to use visual aids and technology to enhance presentations. Course 24: Workplace Confidentiality Understand the importance of workplace confidentiality. Learn to handle sensitive information with discretion and professionalism. Develop strategies for maintaining confidentiality in various workplace scenarios. Course 25: Decision Making and Critical Thinking Online Course Acquire critical thinking skills for effective decision-making. Learn to analyze information, evaluate options, and make informed decisions. Develop strategies for problem-solving in professional settings. Course 26: Workplace Productivity Training Enhance overall workplace productivity through time management. Develop strategies for setting priorities and managing workload. Learn techniques for minimizing distractions and improving focus. Course 27: Influencing and Negotiating Acquire skills in influencing and negotiation for successful outcomes. Learn effective communication and persuasion techniques. Develop strategies for building mutually beneficial relationships. Course 28: Data Entry Administrator Master data entry skills for accuracy and efficiency. Learn to use data entry software and tools effectively. Develop organizational skills crucial for managing large volumes of data. Course 29: Excel Essentials for Office Administrators Acquire proficiency in using Microsoft Excel for office tasks. Learn to create and manage spreadsheets for data analysis. Develop advanced Excel skills for reporting and decision-making. Course 30: Time Management Training Enhance time management skills for improved efficiency. Learn techniques for setting priorities and managing deadlines. Develop strategies for overcoming procrastination and time-wasting habits. 7 Extraordinary Career Oriented courses that will assist you in reimagining your thriving techniques- Course 01: Diploma in Career Development and Passion Gain a comprehensive understanding of career development principles and strategies. Identify and align your passions with potential career paths. Develop a personalized career plan to achieve professional fulfillment and success. Course 02: CV Writing and Job Searching Learn the art of crafting a compelling CV tailored to your target job. 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Learning Outcome This tailor-made Office Administrations and Management bundle will allow you to- Uncover your skills and aptitudes to break new ground in the related fields Deep dive into the fundamental knowledge Acquire some hard and soft skills in this area Gain some transferable skills to elevate your performance Maintain good report with your clients and staff Gain necessary office skills and be tech savvy utilising relevant software Keep records of your work and make a report Know the regulations around this area Reinforce your career with specific knowledge of this field Know your legal and ethical responsibility as a professional in the related field This Office Administrations and Management Bundle resources were created with the help of industry experts, and all subject-related information is kept updated on a regular basis to avoid learners from falling behind on the latest developments. Certification After studying the complete training you will be able to take the assessment. After successfully passing the assessment you will be able to claim all courses pdf certificates and 1 hardcopy certificate for the Title Course completely free. Other Hard Copy certificates need to be ordered at an additional cost of •8. CPD 370 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Ambitious learners who want to strengthen their CV for their desired job should take advantage of the Office Administrations and Management bundle! This bundle is also ideal for professionals looking for career advancement. Requirements To participate in this course, all you need is - A smart device A secure internet connection And a keen interest in Office Administrations and Management Career path Upon completing this essential Bundle, you will discover a new world of endless possibilities. These courses will help you to get a cut above the rest and allow you to be more efficient in the relevant fields.
Supporting people managers The flagship CAPE programme is different to other management development programmes. We offer people management training that supports managers to feel equipped, enabled and empowered to make an immediate and lasting impact. You will benefit from learning how conversation styles, self-belief and authenticity matter and practice your skills with one of our many charity partners towards the end of your training. 12 month multi-element programme Learn new coaching skills Work with charities to utilise your skills Limited spaces £1,795 plus VAT per person Our mission is to help you become a brilliant manager.
Highlights of the Course Course Type: Self-paced online course Training Session: Interactive Online Training Tutor Support: Tutor support is included Customer Support: 24/7 customer support is available Quality Training: The course is designed by an industry expert Recognised Credential: Recognised and Valuable Certification Completion Certificate: Free Course Completion Certificate Included Instalment: 3 Installment Plan on checkout What you will learn from this course? Understand the full procedure and catheterisation techniques. Know the basic categories of catheters Learn how to do a male and female urethral catheterisation. Discover where to insert the post-procedure catheter Learn how to correctly handle and change catheters Discover how to regularly maintain catheter systems Acquire knowledge of maintaining records Identify the risks involved with an indwelling catheter Male and Female Catheterisation Training Course in London This Catheterisation Course will equip you with the required skills and knowledge to handle, insert, and change catheters securely. You will receive hands-on training conducted by specialists in the field and hands-on experience to justify your role. Catheterisation techniques and procedures Anatomy of male and female Different kinds of catheters Causes and types of incontinence Removing an indwelling urethral catheter Prevent and control infection Placing the catheter safely following surgery Post catheterisation care Urethral catheterisation in both men and women Online theoretical learning We offer comprehensive theoretical instruction for the first part of our Catheterisation Course, which you can finish at your convenience. After completing the coursework and tests, you can go to the practical learning section. Offline practical training (designated London office) You will receive practical demonstrations and hands-on training as a part of the practical training to support your role. To ensure optimum attendance, practical training is offered on weekends. You will be needed to attend the training from our office in London, the location of which will be disclosed to you at the time of enrollment. Who is this Course for? This course is open to health visitors, physiotherapists, occupational therapists and healthcare professionals looking to enhance their catheterisation skills This course is also ideal for nurses, midwives, pharmacists and doctors looking to acquire catheterisation skills Anyone who works in the health sector can take this course to refresh their overall catheterisation knowledge and expertise Beginners and aspiring individuals who want to begin their career in the health sector can also take this Catheterisation Course Entry Requirements This Catheterisation Course has no academic prerequisites and is open to students from all academic disciplines. You will, however, need a laptop, desktop, tablet, or smartphone and a reliable internet connection. Assessment This Catheterisation Course assesses learners through multiple-choice questions (MCQs). Upon successful completion of the modules, learners must answer MCQs to complete the assessment procedure. Through the MCQs, it is measured how much a learner can grasp from each section. In the assessment, the pass mark is 60%. You will be guided to the practical learning component, which will be delivered face-to-face, once the coursework and tests have been successfully completed. For practical training, weekend sessions have been implemented to assure the highest possible attendance. Your requirement to attend the training at our London office will be made clear to you upon enrollment. Advance Your Career This Catheterisation Course will provide you with significant opportunities to enter the relevant job market and select your desired career path. Additionally, by showcasing these skills on your resume, you will be able to develop your career, face more competitors in your chosen sector, and increase your level of competition. If you are looking for Advanced Phlebotomy Course - Theory, Lab Practice & Work, enrol into our affordable and highly informative course, which will open your door towards a wide range of opportunities within your chosen sector. This Catheterisation Course is accredited by Continuing Professional Development (CPD) Course Curriculum 1. Introduction to Catheterisation 1. Introduction to Catheterisation 00:05:00 2. Anatomy and Physiology of Urinary System 2. Anatomy and Physiology of Urinary System 00:07:00 3. Methods of Catheterisation 3. Methods of Catheterisation 00:07:00 4. Size of Catheters 4. Size of Catheters 00:03:00 5. Reasons for Catheterisation 5. Reasons for Catheterisation 00:03:00 6. Causes and Types of Incontinence 6. Causes and Types of Incontinence 00:05:00 7. Male Catheterisation Procedure 7. Male Catheterisation Procedure 00:05:00 8. Female Catheterisation Procedure 8. Female Catheterisation Procedure 00:05:00 9. Post Catheterisation Care 9. Post Catheterisation Care 00:03:00 10. Removing an Indwelling Urethral Catheter 10. Removing an Indwelling Urethral Catheter 00:03:00 11. Risks Involved with an Indwelling Catheter 11. Risks Involved with an Indwelling Catheter 00:05:00 12. Infection Control and Prevention 12. Infection Control and Prevention 00:04:00 13. Record Keeping 13. Record Keeping 00:02:00 14. Conclusion 14. Conclusion 00:04:00 Obtain Your Certificate Order Your Certificate of Achievement 00:00:00 Get Your Insurance Now Get Your Insurance Now 00:00:00 Feedback Feedback 00:00:00
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