681 Courses about Healthcare delivered Online

21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.

The sponsor of a clinical trial needs to reach agreement with clinical investigators to conduct the trial. The suitability of investigators and their institutional sites, typically hospitals, has to be evaluated, and the trial has to be set up at each site. This module describes the processes involved, focusing particularly on the role of a Clinical Research Associate (CRA) employed or contracted by the sponsor to monitor the trial.

This module provides a guide to signal detection and management for approved products. The subject is presented as a process comprising four stages: signal detection, signal validation, signal analysis and prioritisation, and risk assessment and minimisation.

This module addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.

The Centralised Procedure (CP) is one of three routes available to applicants to gain multinational marketing authorisation within the European Economic Area (EEA) on the basis of a single application. In the CP, one successful application leads to a marketing authorisation being issued by the European Commission that applies throughout the EEA. The CP is mandatory for certain types of products.

Pharmacokinetic (PK) and pharmacodynamic (PD) studies provide a bridge between science and medicine in the development of a drug. In this module we describe the role of in-vivo PK and PD studies in a drug development programme, set out the uses to which the findings can be put, and discuss their implications for clinical development and application for marketing approval.

The CTD is the internationally recognised standard format for submissions to medicines regulatory authorities. In the European Economic Area, the USA and Canada, the CTD, in its electronic format (eCTD), is mandatory for all applications for marketing approval and all subsequent related submissions. The CTD is accepted in many other countries, being mandatory for new prescription medicines in some. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.

This module provides an understanding of how clinical trials fit into the drug development process. It outlines the key historical events leading to the development of controlled clinical trials. It specifies the purpose of trials, outlines their features, and identifies codes and regulations that apply to them. Finally, it describes the environment of cost control in which the modern pharmaceutical industry operates.

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Health and social care remain a top priority in the UK, particularly for the current pandemic, and staff are always needed to assist the sick and socially disaffected. Worldwide every employer is required by law to monitor their employees' health and social care. Every employee at every level and management, team leaders, and business owners should be aware of the most important health and safety fundamentals. Our Health and Social Care course provides an excellent introduction to working in care and broadens your understanding of working with people of all ages. The Health and Social Care course includes basic human development, legislative frameworks and protocols, how care is accessed and delivered in the UK, and core approaches to service users. By the end of this Health and Social Care course, you will be confident enough to take the next step on the career ladder, as you will learn everything you need to know to successfully work in a care setting and provide assistance to those with a wide range of needs. Learning Outcomes By the end of the Health and Social Care Bundle course, the learner will be able to: Understand Equality, Diversity and Rights in Health and Social Care. Understand Human Growth and Development. Understand safeguarding in Health and Social Care. Why Choose Health and Social Care Course from Us Self-paced course, access available from anywhere. Easy to understand, high-quality study materials. This Course developed by industry experts. MCQ quiz after each module to assess your learning. Health and Social Care Automated and instant assessment results. 24/7 support via live chat, phone call or email. Free PDF certificate as soon as completing the course. >> Benefits of Health and Social Care Course Course 01: Health and Social Care Course 02: Diploma in Health and Wellbeing Course 03: Level 4 Early Years Course >> Other Benefits of Health and Social Care Free 3 PDF Certificate Access to Content - Lifetime Exam Fee - Totally Free Free Retake Exam [ Note: Free PDF certificate as soon as completing the Health and Social Care course] Course Curriculum of Level 3 Award in Health and Social Care Module 01: Equality, Diversity and Rights in Health and Social care Module 02: Human Growth and Development Module 03: Safeguarding in Health and Social Care >> ------------- << Assessment Method After completing each module of the Health and Social Care Course, you will find automated MCQ quizzes. To unlock the next module, you need to complete the quiz task and get at least 60% marks. Certification After completing the MCQ/Assignment assessment for this Health and Social Care course, you will be entitled to a Certificate of Completion from Training Tale. The certificate is in PDF format, which is completely free to download. A printed version is also available upon request. It will also be sent to you through a courier for £13.99. Who is this course for? This course is designed for individuals who want to work in Health and Social Care or who are already working in health and social care and are looking to reinforce their knowledge. Requirements There are no specific requirements for this Health and Social Care Bundle course because it does not require any advanced knowledge or skills. Students who intend to enrol in this Health and Social Care course must meet the following requirements: Good command of the English language Must be vivacious and self-driven Basic computer knowledge A minimum of 16 years of age is required Career path Individuals who wish to pursue a career in the Health and Social Care industry should take this course. Popular job roles include Senior Care Assistants, Support Workers, key workers in residential settings, domiciliary services, and day services. Certificates Certificate of completion Digital certificate - Included