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.
Overview Become a successful English Teacher and teach grateful students from home, a UK classroom, or an academy abroad. This course will enable you to teach English as a second language and open a whole new world of travel and educational opportunities for yourself and others. The Diploma in TEFL/TESOL course describes the best way to research teaching roles and ensure that you are a prime candidate for the absolute best positions. You'll also be taught how to attract prospective learners to your lessons and use creative techniques to educate your eager students quickly. Carve an exciting future for yourself in English education. How will I get my certificate? You may have to take a quiz or a written test online during or after the course. After successfully completing the course, you will be eligible for the certificate. Who is this course for? There is no experience or previous qualifications required for enrolment on this Diploma in TEFL/TESOL. It is available to all students, of all academic backgrounds. Requirements Our Diploma in TEFL/TESOL is fully compatible with PC's, Mac's, Laptop, Tablet and Smartphone devices. This course has been designed to be fully compatible on tablets and smartphones so you can access your course on wifi, 3G or 4G. There is no time limit for completing this course, it can be studied in your own time at your own pace. Career path Having these various qualifications will increase the value in your CV and open you up to multiple sectors such as Business & Management , Admin, Accountancy & Finance, Secretarial & PA, Teaching & Mentoring etc. Course Curriculum 1 sections • 15 lectures • 06:36:00 total length •Module 01: Introduction to English Language Teaching & Learning: 00:16:00 •Module 02: Linguistics: 00:46:00 •Module 03: English Pronunciation: 00:32:00 •Module 04: Teaching Grammar and Vocabulary: 00:36:00 •Module 05: Language Teaching Methodologies: 00:25:00 •Module 06: Teaching Receptive Skills: Reading: 00:20:00 •Module 07: Teaching Productive Skills: Writing: 00:18:00 •Module 08: Teaching Receptive Skills: Listening: 00:14:00 •Module 09: Teaching Productive Skills: Speaking: 00:18:00 •Module 10: Lesson Planning and Creating Materials: 00:30:00 •Module 11: Use of Games and Activities: 00:16:00 •Module 12: Technology in Second Language Teaching & Learning: 00:23:00 •Module 13: Classroom Management and Student Motivation: 00:34:00 •Module 14: Teaching English: Situational Approach: 00:38:00 •Module 15: Professional Development and Employment: 00:30:00
Overview Enrol in our Transport and Logistics Management Level 3 today and build the necessary skills, knowledge and experience to transform your career. The Transport and Logistics Management Level 3 could enhance your continuing professional development thus propelling you more towards your dream job. This Transport and Logistics Management Level 3 could be your key, if you are interested in a long term career in the field of Transport and Logistics Management Level 3. This Transport and Logistics Management Level 3 course consists of a number of easy to digest, in-depth modules which are designed to provide you with detailed knowledge on Transport and Logistics Management Level 3. This Transport and Logistics Management Level 3 aims to accompany you through your journey to help you become a master of Transport and Logistics Management Level 3. Learn through a mixture of interactive lessons and online study materials. How will I get my certificate? At the end of the course there will be a written assignment test which you can take either during or after the course. After successfully completing the test you will be able to order your certificate, these are included in the price. Who is this course for? There is no experience or previous qualifications required for enrolment on this Transport and Logistics Management Level 3. It is available to all students, of all academic backgrounds. Requirements Our Transport and Logistics Management Level 3 is fully compatible with PC's, Mac's, Laptop, Tablet and Smartphone devices. This course has been designed to be fully compatible on tablets and smartphones so you can access your course on wifi, 3G or 4G. There is no time limit for completing this course, it can be studied in your own time at your own pace. Career path Having these various qualifications will increase the value in your CV and open you up to multiple sectors such as Business & Management , Admin, Accountancy & Finance, Secretarial & PA, Teaching & Mentoring etc. Course Curriculum 1 sections • 9 lectures • 02:30:00 total length •Module 01: An Introduction to Successful Transport Management: 00:20:00 •Module 02: The UK's Travel Infrastructure - Road and Rail: 00:10:00 •Module 03: Road Freight and Transport Management: 00:30:00 •Module 04: Passenger Road Transport and its Management: 00:30:00 •Module 05: Rail and Transport Management: 00:15:00 •Module 06: Transport Management for Ports and Inland Waters: 00:15:00 •Module 07: Transport Management for Airlines: 00:10:00 •Module 08: Trends, Challenges and Best Practice in Transport Management: 00:10:00 •Module 09: Transport Management and Health and Safety: 00:10:00