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Prevention of contamination is one of the most important goals of GMP. Contamination of product is often difficult to detect, so GMP rules emphasise preventive measures, including: attention to personal health and hygiene, and the wearing of special clothing, by staff; and cleaning and sanitation of premises and equipment. In this short course we set out the basics of GMP requirements in these vital areas.

A clinical trial, particularly a late-phase commercial study, is a major project requiring collaboration between the sponsor and staff or contractor, on the one hand, and the clinical investigator(s) and other healthcare professionals on the other. Good communication among all parties is essential. In this short course we introduce the major roles in a typical clinical research project and outline their duties.

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 in applications for marketing approval. The International Council for Harmonisation's guideline E6, often referred to as ICH GCP, is the international standard specification for Good Clinical Practice. In this short course we describe the ICH’s role in the harmonisation of regulations, introduce its guideline E6, and set out the principles of GCP.

In clinical trials, endpoints are measurements to evaluate the results of a new treatment, at an individual patient level. The study data can be extrapolated to patient populations on the basis of clinical similarities to patients participating in the trial. When clinical trial data have been obtained, focus is on the trial endpoints; more specifically, the focus is on whether the trial met or failed the primary endpoint specified before the trial started. The purpose and various types of endpoints are discussed in this short course.

The sponsor of a clinical trial takes responsibility for its initiation, management, and/or financing. A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a contract research organisation, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. Duties and functions discussed in this short course include trial design, selection of investigators, QA and QC, data handling and record keeping, finance and compensation, regulatory submissions, management of investigational product(s), safety reporting, monitoring, audit, dealing with noncompliance, and clinical trial reports. ICH guideline E6 (revision 2) encourages sponsors to adopt a risk-based approach to managing the quality of trials. We discuss this approach in general, and aspects such as risk-based monitoring in particular.

Capture and management of clinical trial data is a challenge. The industry is under pressure to obtain and analyse such data more quickly, while maintaining data integrity, so that products can be brought to market sooner. Effective planning and adequate resources can ensure clinical trials yield high quality data within strict timelines and budget requirements, at the same time satisfying regulatory standards. This short course describes the purpose of data capture and explores efficiencies in data management as part of the evolving regulatory landscape.

Good Manufacturing Practice (GMP) is a set of rules for medicines manufacturers to follow so that their products are safe, effective, and of good quality. Everyone who works in a processing, quality control, packaging, or warehouse environment for a pharmaceutical or biotechnology company, or one of their contractors, must understand why GMP is important, how it applies to them, and how to comply with it. This short course explains what GMP is and why it is important, and it gives some lessons from history. It introduces the regulations and guidance documents that are the source of GMP rules. Finally, it touches on regulatory inspections and the consequences that can arise from failure to comply with GMP requirements.

Clinical trial design establishes the framework upon which the clinical trial process will be conducted, and sets the objectives of the trial. The application for marketing approval, submitted to the regulatory authorities, will provide clinical data reflecting the trial design. Since trial design impacts the whole drug development process and lifecycle, particular care and due diligence is essential. This short course provides an overview of the main types of study design.

Start learning Mental Health Course: Childhood & Adolescent that will give you enough knowledge and skills to build your dream career. About this course This Mental Health Course: Childhood & Adolescent helps to grow your skills faster through the power of relevant content and world-class tutors. In this industry-leading bite-sized course, you will learn up-to-date knowledge in the relevant field within a few hours and get certified immediately. The modules of this course are very easy to understand and all of the topics are split into different sections. You will easily grasp and use the knowledge gained from this course in your career and go one step ahead of your competitors. The course is designed to improve your employability and provide you with the tools you need to succeed. Enrol today and start learning your essential skills. 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 Get 24/7 help or advice from our email and live chat teams Get full tutor support on weekdays (Monday to Friday) Course Design The Mental Health Course: Childhood & Adolescent 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 Who Is This Course For:​ This Mental Health Course: Childhood & Adolescent is ideal for those who want to be skilled in this field or who wish to learn a new skill to build their dream career. If you want to gain extensive knowledge, potential experience, and be an expert in the related field then this is a great course for you to grow your career. Requirements This course is for anyone who would like to learn Mental Health Course: Childhood & Adolescent related skills to aid his/her career path. No formal entry prerequisites are required Certification Upon successful completion of the course, you will be able to obtain your course completion e-certificate. Print copy by post is also available at an additional cost of £9.99 and PDF Certificate at £4.99. Course Content Module 01: An Overview of Mental Health Module 02: Introduction to Child Psychology Module 03: Childhood Attachment and Relationship Development Module 04: Separation and Loss' Effects on Attachment Module 05: Factors Affecting Development Course Content Mental Health: Child and Adolescent Module 01: An Overview of Mental Health 00:14:00 Module 02: Introduction to Child Psychology 00:21:00 Module 03: Childhood Attachment and Relationship Development 00:29:00 Module 04: Separation and Loss' Effects on Attachment 00:16:00 Module 05: Factors Affecting Development 00:19:00 Order your Certificates & Transcripts Order your Certificates & Transcripts 00:00:00 Frequently Asked Questions Are there any prerequisites for taking the course? There are no specific prerequisites for this course, nor are there any formal entry requirements. All you need is an internet connection, a good understanding of English and a passion for learning for this course. Can I access the course at any time, or is there a set schedule? You have the flexibility to access the course at any time that suits your schedule. Our courses are self-paced, allowing you to study at your own pace and convenience. How long will I have access to the course? For this course, you will have access to the course materials for 1 year only. This means you can review the content as often as you like within the year, even after you've completed the course. However, if you buy Lifetime Access for the course, you will be able to access the course for a lifetime. Is there a certificate of completion provided after completing the course? Yes, upon successfully completing the course, you will receive a certificate of completion. This certificate can be a valuable addition to your professional portfolio and can be shared on your various social networks. Can I switch courses or get a refund if I'm not satisfied with the course? We want you to have a positive learning experience. If you're not satisfied with the course, you can request a course transfer or refund within 14 days of the initial purchase. How do I track my progress in the course? Our platform provides tracking tools and progress indicators for each course. You can monitor your progress, completed lessons, and assessments through your learner dashboard for the course. What if I have technical issues or difficulties with the course? If you encounter technical issues or content-related difficulties with the course, our support team is available to assist you. You can reach out to them for prompt resolution.

This educational talk demonstrates how Queen Square Radiosurgery Centre has become a hub for cutting-edge research in Radiosurgery. Gain invaluable insights into the clinical benefits of Gamma Knife treatment and its impact on cases that might have otherwise been prescribed whole-brain radiation therapy (WBRT).