This module will introduce you to monoclonal antibodies, explaining how they work, how they are made, and the many uses to which they are put.
An Urgent Safety Restriction (USR) is a regulatory action taken, in response to a safety signal, to make an interim change to the terms of the marketing authorisation for a medicinal product in Europe. This module describes the principles and procedures for USRs.
This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).
Register on the Pharmacology today and build the experience, skills and knowledge you need to enhance your professional development and work towards your dream job. Study this course through online learning and take the first steps towards a long-term career. The course consists of a number of easy to digest, in-depth modules, designed to provide you with a detailed, expert level of knowledge. Learn through a mixture of instructional video lessons and online study materials. Receive online tutor support as you study the course, to ensure you are supported every step of the way. Get a digital certificate as a proof of your course completion. The Pharmacology is incredibly great value and allows you to study at your own pace. Access the course modules from any internet-enabled device, including computers, tablet, and smartphones. The course is designed to increase your employability and equip you with everything you need to be a success. Enrol on the now and start learning instantly! What You Get With The Pharmacology Receive a e-certificate upon successful completion of the course Get taught by experienced, professional instructors Study at a time and pace that suits your learning style Get instant feedback on assessments 24/7 help and advice via email or live chat Get full tutor support on weekdays (Monday to Friday) 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 Certification 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. Who Is This Course For: The course is ideal for those who already work in this sector or are an aspiring professional. This course is designed to enhance your expertise and boost your CV. Learn key skills and gain a professional qualification to prove your newly-acquired knowledge. Requirements: The online training is open to all students and has no formal entry requirements. To study the Pharmacology, all your need is a passion for learning, a good understanding of English, numeracy, and IT skills. You must also be over the age of 16. Course Content Module 01: Fundamental Principles of Pharmacology Fundamental Principles of Pharmacology 00:25:00 Module 02: Drug Development and Regulation Drug Development and Regulation 00:17:00 Module 03: Neuropharmacology Neuropharmacology 00:17:00 Module 04: Cardiovascular Pharmacology Cardiovascular Pharmacology 00:22:00 Module 05: Endocrine Pharmacology Endocrine Pharmacology 00:24:00 Module 06: Chemotherapy Chemotherapy 00:21:00 Module 07: Inflammation and Immune Pharmacology Inflammation and Immune Pharmacology 00:16:00 Module 08: Toxicology Toxicology 00:19:00 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.
Analytical statistical elements are essential concepts in the design of clinical trials. This analysis helps us to understand whether a conclusion from a study of a sample of the target population applies generally to that population as a whole. In particular, it helps us to answer the question: Did the treatment effect in the given study occur just by chance? The statistical elements of a well-controlled study minimise the chances of drawing the wrong conclusions, by providing clear thresholds for such errors. The basic statistical elements of a clinical trial include eligibility criteria, randomisation, sample size, power, and blinding, and these are discussed in this short course.
Informed consent in clinical research is an ethical and regulatory requirement. A research subject must enter a study voluntarily, be informed about risks and benefits, and understand the difference between investigation and treatment. Subjects must not be coerced into enrolment, nor must they be enticed by exaggerated claims of benefit. Before they can enrol, all potential subjects must agree, in writing, to participate. In addition to ethical and regulatory imperatives, the potential for litigation by subjects further highlights the importance of rigorous adherence to informed consent principles. In this short course we set out the principles and requirements and provide examples of practical issues confronting healthcare professionals and subjects.
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.
Regulatory authorities tend to abide by the maxim that ‘If it isn’t documented, it didn’t happen’. Rigorous documentation of all aspects of a clinical trial is necessary to provide evidence of GCP and compliance with regulatory requirements, as well as enabling effective management of the trial. In this short course we describe important examples of the documents designated by ICH GCP as essential to the conduct of a clinical trial.
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.