Regulatory Affairs in Healthcare (MEDC0112)

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.

Lectures


	Digestive Physiology and Pathophysiology and Nutrition Status (x2)
	Routes of Feeding
	An Introduction to Intestinal Failure
	Home Parenteral...

Therapeutic Aspects of Nutrition (MEDC0036)

Lectures

Digestive Physiology and Pathophysiology and Nutrition Status (x2)
	Routes of Feeding
	An Introduction to Intestinal Failure
	Home Parenteral Nutrition
	Metabolism of Parenteral Nutrients
	Prescribing TPN and Management of Short Bowel Patients
	Formulation of Enteral Diets
	Tier 1&2 Weight Management Reduction
	Tier 3&4 Weight Management Reduction
	Nutritional Management of Renal Patients
	Nutritional Management of Liver Patients
	Paediatric TPN
	Weaning from Parenteral Nutrition and Paediatric and Neonatal Enteral Nutrition
	Nutrition in Patients with Long-term Neurodisability
	Nutrition Support in Hospital and Community-Care Settings and Organisation of Nutrition Support Teams
	Measuring Energy Metabolism in Clinical and Community Settings
Learning Objectives

1. Have a sound foundation on which to make observations on the incidence of malnutrition within different patient populations.
2. Have a sound biochemical understanding of digestive physiology and pathophysiology as applied to enteral nutrition.
3. Understand the relationship between macro and micro-nutrient requirements and development and disease, and methods by which requirements may be assessed.
4. Appreciate the special requirements for successful artificial nutrition support for all groups of hospital and community-care patients.
5. Appreciate the multidisciplinary team approach to successful nutrition support