7111 Courses in Cardiff delivered On Demand

Gain essential knowledge and skills related to urinary catheterisation and proper care of catheterised patients with our comprehensive e-learning course. Ideal for healthcare professionals, students, caregivers, and individuals interested in medical care.

Gain essential knowledge and skills related to diabetes, blood glucose monitoring, and insulin administration with our comprehensive e-learning course. Ideal for healthcare professionals, students, caregivers, and individuals interested in diabetes management.

Gain essential knowledge and skills for safe and effective nebuliser administration with our comprehensive e-learning course. Perfect for healthcare professionals, students, caregivers, and medical enthusiasts.

Learn safe and effective gastrostomy tube care and feeding in our comprehensive e-learning course. Ideal for healthcare professionals, students, caregivers, and medical enthusiasts.

Gain essential knowledge and skills for safe and effective use of T34/Bodyguard T syringe driver with our comprehensive e-learning course for healthcare professionals, caregivers, and individuals interested in medical care.

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.

This module extends the learner’s understanding of pharmacokinetic and pharmacodynamic studies from the basics described in our companion module PKPD01, An Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration. It provides detail on a variety of aspects of such studies: design, sampling, data analysis, research in special populations, and bioequivalence testing.

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.

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.