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Description
Healthcare industries are closely regulated by governments in order to ensure safety and efficacy of new medicines. This module provides an introduction to this essential and complex area in healthcare which employs many thousands of scientists across the world. The module describes the history of how regulations were introduced and the current landscape of regulations from the US Food and Drugs Administration (FDA) to the European medicines agency (EMA) and the local UK medicines and healthcare products regulatory agency. Healthcare industries are closely regulated by governments in order to ensure safety and efficacy of new medicines. This module provides an introduction to this essential and complex area in healthcare which employs many thousands of scientists across the world. The module describes the history of how regulations were introduced and the current landscape of regulations from the US Food and Drugs Administration (FDA) to the European medicines agency (EMA) and the local UK medicines and healthcare products regulatory agency. The module is adjusted to bring in topical issues such as regulation of medicines in the pandemic.
The aim of the module is:
To provide an introduction to regulatory affairs with reference to the history of government regulations.
To provide a working knowledge of regulatory affairs through a series of journal clubs, workshops and presentations.
To equip students with sufficient knowledge of regulatory affairs to understand the drug registration process in the major healthcare markets.
Module deliveries for 2024/25 academic year
Last updated
This module description was last updated on 8th April 2024.
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