This module provides comprehensive information on medicines derived from biological sources, including those defined as advanced therapies. It details the legal, ethical, regulatory and practical issues relating to the development of such medicines and provides practical application of the regulatory…
Topic: Innovation and Commercialisation of Research for Patient Benefit
Medicines Regulation
This module, run in parallel with module 8, provides comprehensive information on the role of drug regulation before and during the authorisation of medicines. It details the current national and international regulatory requirements for the authorisation of medicines. It looks…
Non-Clinical Testing, Pharmaceutical and Early Clinical Development
The objective of this module is to develop a higher understanding of the types of pharmaceutical and non-clinical testing carried out on new drug substances and how these fit into the overall development programme. It discusses the principles of early…
Principles of Discovery of Medicines and Development Planning
This module introduces the aims and objectives of the course. It discusses the principles of pharmaceutical medicine. It describes the philosophy behind new drug development and how this impacts on the activity of a pharmaceutical company. Curriculum Content: 1. Setting…
Drug Design & Development
Bringing a drug from bench to bedside is cross-disciplinary. This module enables scholars to put their own research in context and to understand the key parameters in the development of potential novel therapeutics. Outline of content: Identifying drug targets and…
Product Development, Validation & Regulation
In order to design safe and effective medical devices in a timely and efficient fashion, an understanding of how the body is designed to function and how it will likely respond to a medical device is key. This course will…
Innovation & Knowledge II: Transferring Technology From Research to the Knowledge Economy
The Innovation and Knowledge Transfer modules will provide an introduction to the area of Innovation and Entrepreneurship in the context of the Knowledge Economy. Part 2 will cover the management process required to transform an innovative idea into a commercial…
Innovation & Knowledge I: Introduction to Entrepreneurship
The Innovation and Knowledge Transfer modules will provide an introduction to the area of Innovation and Entrepreneurship in the context of the Knowledge Economy. Part I will focus on the entrepreneurial process in the journey from identification of the innovative…
Innovation & Technology Transfer
Aspects of innovation (history, theory, strategy etc) and technology (strategies, acquisition, assessment) will be covered by this course. Intellectual property and asset management, including issues surrounding contracts, licensing, transfer, negotiations and commercialisation will also be explored. Included will be case…
Drug Discovery and Development
Topics covered: The development of the pharmaceutical industry Pharmacokinetic and pharmacology issues in discovery The rise of biopharmaceuticals Delivery of biotech molecules by non-injected routes Gene delivery using viral and non-viral vectors Clinical development from Phase 1-Phase 4 with case…