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An Investigational New Drug Application (IND) is a submission to the US Food and Drug Administration (FDA) for permission to conduct a clinical trial of a medicinal product. This module describes regulatory requirements that sponsors or sponsor-investigators must meet for successful compilation, filing and maintenance of INDs. The IND and its role are defined, and the contexts in which it is required are specified.

To conduct a clinical trial in the European Economic Area under the Clinical Trials Directive the sponsor must apply for authorisation from the national competent authority (i.e. medicines regulator), and favourable opinion must be obtained from a research ethics committee, in each member state in which the trial is to take place. This module sets out the requirements for successful compilation, submission and maintenance of the applications.

Good Clinical Practice (GCP) is a set of internationally recognised ethical and scientific quality requirements for designing, conducting, recording and reporting clinical trials. Compliance with GCP principles is required by regulatory authorities in many countries for the authorisation of clinical trials and the acceptance of their data. The International Council for Harmonisation’s guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice.

Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.

Overview Uplift Your Career & Skill Up to Your Dream Job - Learning Simplified From Home! Kickstart your career & boost your employability by helping you discover your skills, talents and interests with our special Diploma in Social Work Studies Course. You'll create a pathway to your ideal job as this course is designed to uplift your career in the relevant industry. It provides professional training that employers are looking for in today's workplaces. The Diploma in Social Work Studies Course is one of the most prestigious training offered at StudyHub and is highly valued by employers for good reason. This Diploma in Social Work Studies Course has been designed by industry experts to provide our learners with the best learning experience possible to increase their understanding of their chosen field. This Diploma in Social Work Studies Course, like every one of Study Hub's courses, is meticulously developed and well researched. Every one of the topics is divided into elementary modules, allowing our students to grasp each lesson quickly. At StudyHub, we don't just offer courses; we also provide a valuable teaching process. When you buy a course from StudyHub, you get unlimited Lifetime access with 24/7 dedicated tutor support. Why buy this Diploma in Social Work Studies? Unlimited access to the course for forever Digital Certificate, Transcript, student ID all included in the price Absolutely no hidden fees Directly receive CPD accredited qualifications after course completion Receive one to one assistance on every weekday from professionals Immediately receive the PDF certificate after passing Receive the original copies of your certificate and transcript on the next working day Easily learn the skills and knowledge from the comfort of your home Certification After studying the course materials of the Diploma in Social Work Studies there will be a written assignment test which you can take either during or at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £5.99. Original Hard Copy certificates need to be ordered at an additional cost of £9.60. Who is this course for? This Diploma in Social Work Studies course is ideal for Students Recent graduates Job Seekers Anyone interested in this topic People already working in the relevant fields and want to polish their knowledge and skill. Prerequisites This Diploma in Social Work Studies does not require you to have any prior qualifications or experience. You can just enrol and start learning.This Diploma in Social Work Studies was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection. Career path As this course comes with multiple courses included as bonus, you will be able to pursue multiple occupations. This Diploma in Social Work Studies is a great way for you to gain multiple skills from the comfort of your home. Course Curriculum Diploma in Social Work Studies Module 01: An Overview of Social Work 00:19:00 Module 02: Social Work Basics 00:26:00 Module 03: Theories of Social Work and Sociology 00:41:00 Module 04: Casework Process and Teamwork 00:39:00 Module 05: Dimensions of Social Work / Models of Intervention 00:51:00 Module 06: Practice Contexts and Application 00:30:00 Module 07: Working with Adults 00:32:00 Module 08: Principles of Conduct and Role as Social Care Worker 00:24:00

Overview Speech & Language Therapy is a vital field, impacting countless lives in the UK. With over 2.5 million individuals experiencing communication disorders, there’s a growing need for qualified speech and language therapists. This Level 3 Diploma offers a comprehensive introduction to the discipline, equipping learners with the knowledge to support those with speech and language challenges. Throughout the course, you will explore the anatomy and science of speech, gain insights into linguistic disciplines, and learn about literacy and language development. You will also delve into the characteristics and causes of speech and language disorders in both children and adults, preparing you to address these challenges effectively. Whether you aspire to work in educational settings, healthcare, or private practice, this diploma provides a solid foundation in speech & language therapy. Join us to embark on a fulfilling journey where you can make a significant difference in the lives of those with speech and language difficulties. Become proficient in Level 3 Diploma in Speech & Language Therapy Course by grasping all the essential knowledge from our top-quality course step by step. Enrol now to ensure that your Level 3 Diploma in Speech & Language Therapy Course mastery is not limited to only conceptual frameworks! This Level 3 Diploma in Speech & Language Therapy Course will assist you in standing out from the crowd and being more efficient in your chosen area of expertise. Furthermore, if you require assistance with the Level 3 Diploma in Speech & Language Therapy Course, we will provide experts who will support and guide you. So, add this Level 3 Diploma in Speech & Language Therapy Course to your cart and boost your personal and career development. Learning Outcome Understand how speech science contributes to the development of spoken language understanding Consider how literacy and language development affect a child's academic progress Explain how Child Speech and Language Disorders influence a child's reading and writing skills Adopt some tried-and-true strategies to assist children who are having difficulty communicating Description Speech and Language Therapy (SLT) is an important health discipline that is responsible for the management and care of children and adults with communication and swallowing disorders.  Please note that this online training does not entitle you to practise as a registered speech and language therapist. If you are looking for a course to comply with HCPC's requirements, please contact the HCPC. Course design The course is delivered through our online learning platform, accessible through any internet-connected device such as laptop, tab or smartphones. There are no deadlines or teaching schedules, meaning you are free to study the course at your own pace.  You are taught through a combination of Video lessons Online study materials Certificate of Achievement Endorsed Certificate of Achievement from the Quality Licence Scheme After successfully completing the course, learners will be able to order an endorsed certificate as proof of their new achievement. Endorsed certificates can be ordered and get delivered to your home by post for only £109. There is an additional £10 postage charge for international students. CPD Certification from Institute of Mental Health After successfully completing the MCQ assessment of this course, you will qualify for the CPD Certificate from Institute of Mental Health, as proof of your continued professional development. Certification is available in PDF format, at the cost of £9, or a hard copy can be sent to you via post, at the cost of £15. Endorsement This course has been endorsed by the Quality Licence Scheme for its high-quality, non-regulated provision and training programmes. This course is not regulated by Ofqual and is not an accredited qualification. Your training provider will be able to advise you on any further recognition, for example progression routes into further and/or higher education. For further information please visit the Learner FAQs on the Quality Licence Scheme website. Method of Assessment To assess your learning, you have to participate in an automated multiple choice question exam. You have to score at least 60% to pass the exam and to qualify for Quality Licence Scheme endorsed and CPD accredited certificates. After passing the exam, you will be able to apply for a certificate. In addition, to enhance the depth of your knowledge regarding the course and further assess your learning, you are advised to complete the assignment questions provided at the end of the course, which you can complete anytime you wish. After submitting the assignment, our expert tutor will assess your assignment and will give you feedback on your performance. Why study this course Whether you're an existing practitioner or aspiring professional, this course will enhance your expertise and boost your CV with key skills and knowledge. Who is This course for? Speech And Language Therapy course is ideal for - People looking to develop skills and expertise in speech & language therapy People aspiring for new jobs/promotions at their existing jobs Anyone looking to learn a new skill or acquire some knowledge Requirements The Speech And Language Therapy course is open to all, with no entry requirements. All you need to have a passion for learning, a good understanding of the English language, numeracy and IT, and to be over the age of 16. Course Curriculum Speech And Language Therapy Module 01: An Overview of Speech Therapy Module 01: An Overview of Speech Therapy 00:13:00 Module 02: The Science of Speech Module 02: The Science of Speech 00:20:00 Module 03: The Anatomy of Speech Module 03: The Anatomy of Speech 01:00:00 Module 04: Characteristic of Speech: Linguistic Discipline Module 04: Characteristic of Speech: Linguistic Discipline 00:27:00 Module 05: Literacy and Language Development Module 05: Literacy and Language Development 00:22:00 Module 06: Child Speech & Language Disorders Module 06: Child Speech & Language Disorders 00:32:00 Module 07: Adult Speech & Language Disorders Module 07: Adult Speech & Language Disorders 00:29:00 Module 08: How to Help a Child with SL Difficulties Module 08: How to Help a Child with SL Difficulties 00:25:00 Mock Exam Mock Exam - Speech And Language Therapy 00:20:00 Final Exam Final Exam - Speech And Language Therapy 00:20:00 Assignment Assignment - Speech And Language Therapy 2 weeks, 6 days

Level 2 & 3 Diploma in Health & Social Care + Care Certificate Standards (1 to 15) 3 Exclusive Health & Social Care Package Latest Course Curriculum (Updated July 23) Free MCQ Exam Video Based Course Unlimited Retake Do you wish to work in the rewarding Health Social Care : Health & Social Care industry and help people achieve success in their daily lives? Have you thought about working as a nurse, paramedic, health visitor, or social worker? Are you looking for a way to break into the industry? If so, this Health Social Care : Level 3 Health & Social Care Diploma course can help you gain the information and skills you need to develop your career and open doors to exciting Health Social Care : Health & social care opportunities. Courses Are Included in this Health Social Care : Health & Social Care Bundle: Course 01: Level 3 Award in Health & Social Care Course 02: Level 6 Diploma in Health & Social Care Management Course 03: Care Certificate (Standards 1 to 15) Course 04: Advanced Diploma in Child Care Main Course: Level 3 Award in Health & Social Care Free Courses are including with this Health Social Care : Health & Social Care Course Along with The Health Social Care : Health & Social Care Course, We Offer a free Level 6 Diploma in Health & Social Care Management Course Along with The Health Social Care : Health & Social Care Course, We Offer a free Care Certificate (Standards 1 to 15) Course Along with The Health Social Care : Health & Social Care Course, We Offer a free Advanced Diploma in Child Care Course Why Choose Health Social Care : Health & Social Care Course From Wise Campus? Health Social Care : Self-paced course, access available from anywhere in the world. Health Social Care : High-quality study materials that are easy to understand. Health Social Care : Health & Social Care Course developed by industry experts. Health Social Care : After each module, there will be an MCQ quiz to assess your learning. Health Social Care : Assessment results are generated automatically and instantly. Health Social Care : 24/7 support is available via live chat, phone call, or email. Free PDF certificate after completing the Health Social Care : Health & Social Care course. Special Offers of this Health & Social Care Course This Health & Social Care Course includes a FREE PDF Certificate. Lifetime access to this Health & Social Care Course Instant access to this Health & Social Care Course Get FREE Tutor Support to this Health & Social Care: Health & Social Care Course Level 2 & 3 Diploma in Health & Social Care + Care Certificate Standards (1 to 15) Embark on a transformative journey with our comprehensive Health & Social Care course designed to empower you with the knowledge and skills needed to excel in this dynamic field. Whether you're a seasoned professional or just starting your career, our program is tailored to elevate your expertise in Health & Social Care. Who is this course for? Level 2 & 3 Diploma in Health & Social Care + Care Certificate Standards (1 to 15) Anyone interested in pursuing a career in one of the following fields might consider taking our Health Social Care : Health & Social Care course Requirements Level 2 & 3 Diploma in Health & Social Care + Care Certificate Standards (1 to 15) To enrol in this Health Social Care : Health & Social Care Course, students must fulfil the following requirements: Good Command over English language is mandatory to enrol in our Health Social Care : Health & Social Care Course. Be energetic and self-motivated to complete our Health Social Care : Health & Social Care Course. Basic computer Skill is required to complete our Health Social Care : Health & Social Care Course. If you want to enrol in our Health Social Care : Health & Social Care Course, you must be at least 15 years old. Career path Level 2 & 3 Diploma in Health & Social Care + Care Certificate Standards (1 to 15)

SEN Teaching Assistants are responsible for a wide range of practical and administrative tasks. Their work helps support pupils' learning and creates more available time for teaching. There is a huge demand for SEN Teaching Assistants, and if you think you're up to the challenge then this award-winning Special Educational Needs (SEN) Teaching Assistant course is the perfect course for you. The course is structured into 9 modules with expertly designed online study materials and video lessons which will teach you everything you need to succeed. You will also discover how to identify students most in need of support and plan for the special educational needs of various pupils. After taking this course, you will be fully prepared to become an ideal teaching assistant to all children and make a real difference to a child's learning. Why Choose this Course? Earn a digital Certificate upon successful completion. Accessible, informative modules taught by expert instructors Study in your own time, at your own pace, through your computer tablet or mobile device Benefit from instant feedback through mock exams and multiple-choice assessments Get 24/7 help or advice from our email and live chat teams Full tutor support on weekdays Course Design The course is delivered through our online learning platform, accessible through any internet-connected device. There are no formal deadlines or teaching schedules, meaning you are free to study the course at your own pace. You are taught through a combination of Video lessons Online study materials Mock exams Multiple-choice assessment Certificate of Achievement CPD Certificate from Janets Upon successful completion of the course, you will be able to obtain your course completion e-certificate free of cost. Print copy by post is also available at an additional cost of £9.99 and PDF Certificate at £4.99. Method of Assessment To successfully complete the course, students will have to take an automated multiple-choice exam. This exam will be online and you will need to score 60% or above to pass the course. To verify your enhanced skills in the subject, we recommend that you also complete the assignment questions. These can be completed at any time which is convenient for yourself and will be assessed by our in-house specialised tutors. Full feedback will then be given on your current performance, along with any further advice or support. Who is this course for? Special Educational Needs (SEN) Teaching Assistant course is suitable for anyone who want to gain extensive knowledge, potential experience and expert skills in the related field. This is a great opportunity for all student from any academic backgrounds to learn more on this subject. Career path Training offered by the Special Educational Needs (SEN) Teaching Assistant course could potentially benefit a range of roles, but would particularly enhance careers in Education Teaching Training Support Work SEN Education Other expert SEN teaching roles

Overview of Mental Health Care - MCA and DOLS Join our Child and Adolescent Mental Health course and discover your hidden skills, setting you on a path to success in this area. Get ready to improve your skills and achieve your biggest goals. The Child and Adolescent Mental Health course has everything you need to get a great start in this sector. Improving and moving forward is key to getting ahead personally. The Child and Adolescent Mental Health course is designed to teach you the important stuff quickly and well, helping you to get off to a great start in the field. So, what are you looking for? Enrol now! This Mental Health Care - MCA and DOLS Course will help you to learn: Learn strategies to boost your workplace efficiency. Hone your skills to help you advance your career. Acquire a comprehensive understanding of various topics and tips. Learn in-demand skills that are in high demand among UK employers This course covers the topic you must know to stand against the tough competition. The future is truly yours to seize with this Child and Adolescent Mental Health. Enrol today and complete the course to achieve a certificate that can change your career forever. Details Perks of Learning with IOMH One-To-One Support from a Dedicated Tutor Throughout Your Course. Study Online — Whenever and Wherever You Want. Instant Digital/ PDF Certificate. 100% Money Back Guarantee. 12 Months Access. Process of Evaluation After studying the course, an MCQ exam or assignment will test your skills and knowledge. You have to get a score of 60% to pass the test and get your certificate. Certificate of Achievement Certificate of Completion – Digital / PDF Certificate After completing the Child and Adolescent Mental Health course, you can order your CPD Accredited Digital/ PDF Certificate for £5.99. Certificate of Completion – Hard copy Certificate You can get the CPD Accredited Hard Copy Certificate for £12.99. Shipping Charges: Inside the UK: £3.99 International: £10.99 Who Is This Course for? This Child and Adolescent Mental Health is suitable for anyone aspiring to start a career in relevant field; even if you are new to this and have no prior knowledge, this course is going to be very easy for you to understand. On the other hand, if you are already working in this sector, this course will be a great source of knowledge for you to improve your existing skills and take them to the next level. This course has been developed with maximum flexibility and accessibility, making it ideal for people who don’t have the time to devote to traditional education. Requirements You don’t need any educational qualification or experience to enrol in the Child and Adolescent Mental Health course. Do note: you must be at least 16 years old to enrol. Any internet-connected device, such as a computer, tablet, or smartphone, can access this online course. Career Path The certification and skills you get from this Child and Adolescent Mental Health Course can help you advance your career and gain expertise in several fields, allowing you to apply for high-paying jobs in related sectors.