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 leadership course explores the application of emotional intelligence at work as a core underpinning skill of leadership. Your emotional intelligence helps you to manage your thinking along with your emotions to make authentic decisions and build quality relationships.
The course gives you practical tools and actions to begin leading inclusively with immediate effect. You will strengthen your relationships with others, build your awareness of unconscious bias, develop your critical thinking skills, and become a senior advocate for inclusive workplace cultures. You can expect to see the results of a more inclusive culture, both internally and externally, very quickly.
This highly practical course is unusual because it considers emotional intelligence as a fundamental part of selling. The course doesn't cover prospecting and ways to get a sales appointment, these require the use of emotional intelligence in other ways! The course covers the way that you engage with customers before, during and after a sales meeting through the application of emotional intelligence to make authentic decisions and build quality relationships. The course provides a step-by-step approach to applying emotional intelligence principles to your sales process focusing on working with the emotions of your customer and how these influence their social interactions.
This course is perfect for the beginner but also delves into building a SAS Model and intermediate topics. Learn SAS Data Step, SQL Step, Macros, SAS Model Building, Predictive Analytics, SAS and ML. If you are using SAS Enterprise Guide and want to learn how to code/program instead of using the point-and-click interface, this course is ideal!
Welcome to GLA Tutors, a pioneering platform for primary school tutoring and SATs preparation. At GLA Tutors, we understand the importance of a strong foundation in primary school subjects and strive to provide comprehensive support to help children excel in their academic journey. Our team of expert tutors is well-versed in the English National Curriculum, which forms the basis of primary school education in the UK. We have carefully analysed the curriculum requirements to ensure that our tutoring services cover all key subjects and align with the learning objectives set by the curriculum. Our provision for tutoring all primary school subjects encompasses a wide range of subjects, including: 1. English: - Reading comprehension - Vocabulary development - Grammar and punctuation - Writing skills 2. Mathematics: - Number and place value - Addition, subtraction, multiplication, and division - Fractions, decimals, and percentages - Geometry and measurement 3. Science: - Investigating scientific phenomena - Understanding the natural world - Conducting experiments and making observations - Developing scientific thinking and inquiry skills 4. History: - Understanding historical events and timelines - Exploring significant figures and civilizations - Analysing primary and secondary sources - Developing historical knowledge and critical thinking skills 5. Geography: - Studying different landscapes and environments - Investigating human and physical geography - Exploring global issues and sustainability - Developing geographical skills and understanding At GLA Tutors, we understand that preparing children for SATs can be a challenging task. Our tutors are well-versed in the SATs format and content, and they provide targeted support to help children excel in their exams. We cover all areas of the SATs, including English (reading, grammar, and writing) and Mathematics, ensuring that children are well-prepared and confident on exam day. Our tutoring sessions are designed to be engaging and interactive, fostering a love for learning and encouraging children to reach their full potential. We use a variety of teaching techniques, including hands-on activities, visual aids, and interactive resources, to make learning enjoyable and effective. With GLA Tutors, you can be assured that your child will receive top-quality tutoring in all primary school subjects and be well-prepared for SATs. Our tutors are committed to providing personalised support, tailoring their teaching methods to meet the unique learning needs of each child. Join us and let us help your child thrive academically and achieve success in their primary school journey and SATs.
This Paramedicine Study bundle offers an extensive foundation across critical healthcare topics tailored for aspiring healthcare support professionals and those seeking to enhance their knowledge in emergency and medical care. Delivered through expertly designed modules, the course covers vital areas such as ambulance care, cardiopulmonary resuscitation (CPR), medication management, and medical law, ensuring a well-rounded understanding of essential paramedic and healthcare practices. Each module provides clear and accessible content designed to build confidence and deepen awareness of key health concepts, from infection control to anatomy, without the need for physical attendance. The course is designed to be flexible, allowing learners to study at their own pace while gaining recognised CPDQS accreditation. With a focus on areas like epidemic awareness, cardiac care, and clinical observation, this bundle is ideal for those interested in healthcare roles that demand solid theoretical knowledge and critical thinking. Whether preparing for new responsibilities or refreshing existing skills, this programme presents a valuable opportunity to expand your healthcare expertise through engaging, professional-level study. Key Features of Paramedicine Study Bundle CPD Accredited Paramedicine Study Course Instant PDF certificate Fully online, interactive Paramedicine Study course Self-paced learning and laptop, tablet, smartphone-friendly 24/7 Learning Assistance Discounts on bulk purchases Enrol now in this Paramedicine Study Bundle course to excel! To become successful in your profession, you must have a specific set of Paramedicine Study skills to succeed in today's competitive world. In this in-depth Paramedicine Studytraining course, you will develop the most in-demand Paramedicine Study skills to kickstart your career, as well as upgrade your existing knowledge & skills. Paramedicine Study Curriculum Course 01: Paramedicine Study Course 02: Ambulance Care Assistant Course 03: CPR (Cardiopulmonary Resuscitation) Training Course 04: Medical Law Course 05: Care Planning and Record Keeping Course 06: Medication Course 07: Pharmacology Course 08: Care Certificate (Standards 1 to 15) Course 09: Epidemic and Pandemic Disease Awareness Course 10: Basic First Aid Course 11: Personal Hygiene Course Course 12: Infection Prevention & Control: Health & Safety Consultant Course 13: Safe Handling of Medicines Course 14: Basic Life Support Course 15: Cardiac (Heart) Care Course 16: Anatomy and Physiology Course 17: Physiotherapy: Pain Management Course 18: Concussion and Brain Injury Awareness Course 19: Clinical Observations Skills Course 20: Microbiology Laboratory Technician Accreditation This Paramedicine Study bundle courses are CPD accredited, providing you with up-to-date skills and knowledge and helping you to become more competent and effective in your chosen field. Certification Once you've successfully completed your Paramedicine Study course, you will immediately be sent a digital certificate. Also, you can have your printed certificate delivered by post (shipping cost £3.99). CPD 200 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This course is ideal for all employees or anyone who genuinely wishes to learn more about Paramedicine Study basics. Please Note: This course is not a regulated course and doesn't provide any professional qualifications. This course aims to provide basic information about Paramedicine studies. Requirements No prior degree or experience is required to enrol in this course. Career path This Paramedicine Study Course will help you to explore avariety of career paths in the related industry. Certificates Digital certificate Digital certificate - Included Hardcopy Certificate Hard copy certificate - Included Hardcopy Certificate (UK Delivery): For those who wish to have a physical token of their achievement, we offer a high-quality, printed certificate. This hardcopy certificate is also provided free of charge. However, please note that delivery fees apply. If your shipping address is within the United Kingdom, the delivery fee will be only £3.99. Hardcopy Certificate (International Delivery): For all international addresses outside of the United Kingdom, the delivery fee for a hardcopy certificate will be only £10.
24 Hours Left! Don't Let Year-End Deals Slip Away - Enrol Now! This Advanced Diploma in Professional Photography at QLS Level 7 course is endorsed by The Quality Licence Scheme and accredited by CPDQS (with 180 CPD points) to make your skill development & career progression more accessible than ever! Are you looking to improve your current abilities or make a career move? If yes, our unique Professional Photography at QLS Level 7 course might help you get there! It is an expertly designed course which ensures you learn everything about the topic thoroughly. Expand your expertise with high-quality training from the Professional Photography at QLS Level 7 course. Due to Professional Photography at QLS Level 7's massive demand in the competitive market, you can use our comprehensive course as a weapon to strengthen your knowledge and boost your career development. Learn Professional Photography at QLS Level 7 from industry professionals and quickly equip yourself with the specific knowledge and skills you need to excel in your chosen career. The Professional Photography at QLS Level 7 course is broken down into several in-depth modules to provide you with the most convenient and rich learning experience possible. Upon successful completion of the Professional Photography at QLS Level 7 course, an instant e-certificate will be exhibited in your profile that you can order as proof of your skills and knowledge. Add these amazing new skills to your resume and boost your employability by simply enrolling in this Professional Photography at QLS Level 7 course. This Professional Photography at QLS Level 7 training can help you to accomplish your ambitions and prepare you for a meaningful career. So, join us today and gear up for excellence! Why Prefer This Professional Photography at QLS Level 7 Course? Opportunity to earn a certificate endorsed by the Quality Licence Scheme & another accredited by CPDQS which is completely free. Get a free student ID card! (£10 postal charge will be applicable for international delivery) Innovative and engaging content. Free assessments 24/7 tutor support. Take a step toward a brighter future! *** Course Curriculum *** Here is the curriculum breakdown of the Professional Photography at QLS Level 7 course: Assessment Process With MCQ: After completing an online module, you will be given immediate access to a specially designed MCQ test. The results will be immediately analysed, and the score will be shown for your review. The passing score for each test will be set at 60%. You will be entitled to claim a certificate endorsed by the Quality Licence Scheme after you have completed all of the Advanced Diploma in Professional Photography at QLS Level 7 exams. OR With Assignment: You have to complete the assignment questions given at the end of the course and score a minimum of 60% to pass each exam. Our expert trainers will assess your assignment and give you feedback after you submit the assignment. You will be entitled to claim a certificate endorsed by the Quality Licence Scheme after you have completed all of the Advanced Diploma in Professional Photography at QLS Level 7 exams. CPD 180 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This Professional Photography at QLS Level 7 course is perfect for highly motivated people who want to improve their technical skills and prepare for the career they want! Requirements No prior background or expertise is required. Career path The Professional Photography at QLS Level 7 course will boost your CV and aims to help you get the job or even the long-awaited promotion of your dreams. Certificates Advanced Diploma in Professional Photography at QLS Level 7 Hard copy certificate - Included Show off Your New Skills with a Certificate of Completion After successfully completing the Advanced Diploma in Professional Photography at QLS Level 7, you can order an original hardcopy certificate of achievement endorsed by the Quality Licence Scheme and also you can order CPDQSAccredited Certificate that is recognised all over the UK and also internationally. The certificates will be home-delivered, completely free of cost. CPDQS Accredited Certificate Digital certificate - Included
This course is expertly designed to deepen your understanding of investment banking and the essential financial tools needed for astute business decision-making. Across ten focused modules, you will explore the intricacies of investment strategies, financial analysis, and corporate finance. From mastering financial modelling techniques to crafting detailed business plans, the course offers a thorough exploration of the financial landscape without requiring physical attendance. Whether your interest lies in financial reporting, commercial law, or tax considerations, each section builds a solid foundation to enhance your financial literacy and strategic thinking. In addition, the programme addresses critical areas such as anti-money laundering and financial crime prevention, ensuring you are aware of the legal and regulatory environment surrounding finance today. Delivered entirely online, this course allows you to develop knowledge at your own pace, making it ideal for professionals seeking to advance their expertise in investment banking and financial planning. Perfect for those aiming to sharpen their financial decision-making abilities, this course balances theory with insightful analysis to support confident, informed choices in a competitive market. Key Features of Investment Banking, Financial Modelling for Decision Making and Business Plan Bundle CPD Accredited Investment Banking, Financial Modelling for Decision Making and Business Plan Course Instant PDF certificate Fully online, interactive Investment Banking, Financial Modelling for Decision Making and Business Plancourse Self-paced learning and laptop, tablet, smartphone-friendly 24/7 Learning Assistance Discounts on bulk purchases Enrol now in this Investment Banking, Financial Modelling for Decision Making and Business Plan Bundle course to excel! To become successful in your profession, you must have a specific set of Investment Banking, Financial Modelling for Decision Making and Business Plan skills to succeed in today's competitive world. In this in-depth Investment Banking, Financial Modelling for Decision Making and Business Plantraining course, you will develop the most in-demand Investment Banking, Financial Modelling for Decision Making and Business Plan skills to kickstart your career, as well as upgrade your existing knowledge & skills. Investment Banking, Financial Modelling for Decision Making and Business Plan Curriculum Course 01: Investment Banking Course 02: Investment Course 03: Financial Analysis Course 04: Financial Modelling Course 05: Business Plan Course 06: Corporate Finance Course 07: Financial Reporting Course 08: AML & Financial Crime Prevention Course 09: Commercial Law Course 10: Tax Accreditation This Investment Banking, Financial Modelling for Decision Making and Business Plan bundle courses are CPD accredited, providing you with up-to-date skills and knowledge and helping you to become more competent and effective in your chosen field. Certification Once you've successfully completed your Investment Banking, Financial Modelling for Decision Making and Business Plan course, you will immediately be sent a digital certificate. Also, you can have your printed certificate delivered by post (shipping cost £3.99). CPD 100 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This course is ideal for all employees or anyone who genuinely wishes to learn more about Investment Banking, Financial Modelling for Decision Making and Business Plan basics. Requirements No prior degree or experience is required to enrol in this course.= Career path This Investment Banking, Financial Modelling for Decision Making and Business Plan Course will help you to explore avariety of career paths in the related industry. Certificates Digital certificate Digital certificate - Included Hardcopy Certificate Hard copy certificate - Included Hardcopy Certificate (UK Delivery): For those who wish to have a physical token of their achievement, we offer a high-quality, printed certificate. This hardcopy certificate is also provided free of charge. However, please note that delivery fees apply. If your shipping address is within the United Kingdom, the delivery fee will be only £3.99. Hardcopy Certificate (International Delivery): For all international addresses outside of the United Kingdom, the delivery fee for a hardcopy certificate will be only £10.