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.
Explore the art and science of chiropractic adjustments with our comprehensive course on the Chiropractor Profession. Gain insights into the philosophy, principles, and practical applications of chiropractic care. Learn various adjustment techniques, understand spinal health, and discover the holistic approach chiropractors bring to healthcare. Whether you're a healthcare professional or a wellness enthusiast, this course equips you with the knowledge and skills to contribute to overall well-being through evidence-based chiropractic practices. Enroll now and embark on a journey to master the chiropractic profession
Face Painting Course Overview Face painting is a fun activity, perfect for festivals, children's birthday parties and other fun occasions. Parents will also love getting creative with different types of face paints. If you want to learn the basics of face painting, this Face Painting Course will guide you step-by-step on how to create amazing face paint designs, including an introduction into the history of face painting. This online course consists of various user-friendly modules that are all geared towards helping you learn about face and body painting for kids. The course is divided into three sections: beginner, intermediate, and advanced face painting ideas. You'll learn expert face painting techniques, helping you to gain confidence in your artistic abilities, whether you want to become a professional face painter, or have some fun with your little ones at special celebrations. You will also learn how to take care of your skin and will familiarise with health and safety codes of practice. Whatever your academic background, this introductory face painting training course will help you to learn face painting on a basic level, building you up to eventually creating real masterpieces any child would be proud to show off! Course Preview Who is the Face Painting Course for? People interested in drawing face paintings as a part of an amusing hobby. Art professional who need this skill at the workplace. Entry Requirement This course is available to all learners, of all academic backgrounds. Learners should be aged 16 or over to undertake the qualification. Good understanding of English language, numeracy and ICT are required to attend this course. Why choose us? Affordable, engaging & high-quality e-learning study materials; Tutorial videos/materials from the industry leading experts; Study in a user-friendly, advanced online learning platform; Efficient exam systems for the assessment and instant result; The UK & internationally recognized accredited qualification; Access to course content on mobile, tablet or desktop from anywhere anytime; The benefit of career advancement opportunities; 24/7 student support via email.AssessmentAssessment test is not required in this course Certificate of Achievement After completing this course successfully, you will be able to obtain an Accredited Certificate of Achievement. Certificates & Transcripts can be obtained either in Hardcopy at £14.99 or in PDF format at £11.99. Career Path The course is a useful qualification to possess and would be beneficial for any related profession or industry such as: Theme parks. Kindergarten and nursery schools. Sports and recreational events. Theatres and Live events. Face Painting Course Module 01: Introduction to Face Painting 00:16:00 Module 02: Face Painting Tools and Techniques 00:15:00 Module 03: Face Painting for Different Occasions 00:13:00 Module 04: Creative Face Painting Designs 00:12:00 Module 05: Advanced Face Painting Techniques 00:13:00 Module 06: Business and Professional Development 00:15:00 Order Your Certificates and Transcripts Order Your Certificates and Transcripts 00:00:00