10639 Professional Development courses in London delivered On Demand

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.

Medicines for the prevention, diagnosis, or treatment of rare diseases have become known as ‘orphan drugs’ because of their commercial unattractiveness. Development of such products is successfully encouraged through incentives offered by regulatory authorities. To qualify for important incentives, the sponsor of a drug must gain ‘orphan designation’ for its use in an indication. This module describes the requirements for orphan designation and how to apply for it in the USA and the European Economic Area.

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.

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 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 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.

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. The rules may be written into law or set out in guidance documents from regulatory authorities. Regulators will not allow medicinal products to be placed, or to remain, on the market in their country unless the products can be shown to be manufactured in compliance with GMP. To this end, they carry out inspections of manufacturing plants. Companies that persistently commit serious breaches of GMP requirements have suffered huge fines.

The warehouse plays a crucial role in a medicinal products factory. This module explains the requirements of Good Manufacturing Practice (GMP) for the warehouse, and how to comply with them.

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.

Register on the Basic to Advanced UX Design 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 Basic to Advanced UX Design course 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! 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 supplies Assignment Certificate of Achievement Endorsed Certificate of Achievement from the Quality Licence Scheme Once the course has been completed and the assessment has been passed, all students are entitled to receive an endorsed certificate. This will provide proof that you have completed your training objectives, and each endorsed certificate can be ordered and delivered to your address for only £119. Please note that overseas students may be charged an additional £10 for postage. CPD Certificate of Achievement 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. Endorsement This course and/or training programme has been endorsed by the Quality Licence Scheme for its high-quality, non-regulated provision and training programmes. This course and/or training programme 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 In order to ensure the Quality Licensing scheme endorsed and CPD acknowledged certificate, learners need to score at least 60% pass marks on the assessment process. After submitting assignments, our expert tutors will evaluate the assignments and give feedback based on the performance. After passing the assessment, one can apply for a certificate. 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.