11307 Courses

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.

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.

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.

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 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.

This short course introduces staff to a range of hazardous substances, the risks and controls available, and what to expect from a control of substances hazardous to health (COSHH) assessment. It prepares them to contribute to the safer use of hazardous substances in their workplaces. 1 Definition and types Defining what constitutes a substance hazardous to health in the workplace Outlining the various types of hazardous substances 2 Health effects Exploring the health effects caused by exposure to hazardous substances Routes of entry - exploring how substances can enter the body and methods of prevention 3 Data COSSH register Data sheets Risk assessments Control options 4 Responsibilities An overview of the responsibilities imposed by the Control of Substances Hazardous to Health Regulations 2002

Empower your skills in protecting vulnerable adults with our Safeguarding course. Master key laws, understand abuse dynamics, and learn effective response strategies. This course is a comprehensive guide to creating a safer environment for adults in need.

Elevate your safeguarding skills to a professional level with our Level 3 course focused on Safeguarding Children and Vulnerable Adults. Learn to identify signs of abuse, understand legal frameworks, and master the protocols for effective reporting and communication. Become a cornerstone in the protection and welfare of society’s most vulnerable.