59278 Courses

Host your own group to learn how to make a fabulous flower crown using fresh or dried flowers.

I often buy clothes and accessories spontaneously. This results in a wardrobe full of pieces that don’t pair with anything. “I have nothing to wear….” I hear you say. A handful of treasures just hanging in there before progressing into a charity giveaway bag. Not if you know your true colours that will elevate your look and mood as well as save money and the environment. Based on this colour analysis we can create a capsule wardrobe using your existing pieces and follow your colour chart to purchase matching items in future. Whatever fashion dictates, buying less and more consciously will reduce waste, save money and creates a wonderful wardrobe you can be proud of! The analysis is based on inherited tones as well as personality. Based on 4 seasons: spring and autumn being warm and summer and winter cool in the colour spectrum.

This course covers the fundamental topics of statistical methodology, linear regression, and ordinary least squares that every statistician needs to know.

Create a real-world backend for a Bootcamp directory app

Build 20 mini frontend projects from scratch with HTML5, CSS, and JavaScript

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 CTD is the internationally recognised standard format for submissions to medicines regulatory authorities. In the European Economic Area, the USA and Canada, the CTD, in its electronic format (eCTD), is mandatory for all applications for marketing approval and all subsequent related submissions. The CTD is accepted in many other countries, being mandatory for new prescription medicines in some. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.

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.

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.

21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.