This module, run in parallel with module 7, provides comprehensive information on the role of drug regulation with a particular emphasis on the regulation of drug safety during and after the authorisation phase of drug development. It details the current…
Topic: Clinical Research
Special Populations: Clinical Trial Practice and Regulation
This module provides in-depth knowledge into the impact of the specific target population on the undertaking of clinical research. It details the importance of taking physiological profile, disease characteristics into account and provides practical examples of how to conduct clinical…
Clinical Trials
This module provides comprehensive information on the clinical development of new medicines. It describes the choice of clinical trial design and target populations, according to the proposed indication for use. It examines in detail the key issues involved in the…
Exploratory and Confirmatory Clinical Development
The aim of this module is to provide a comprehensive overview of the main types of studies used in clinical research and the legal, methodological and ethical issues involved in the undertaking of biomedical research. It will detail the principles…
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…
Managing Health Information
This module forms part of the Graduate Certificate in Clinical & Translational Research and the Graduate Diploma in Health Informatics. The goal of this module is to introduce students to key concepts in healthcare informatics and management of health information…
Data Management for Clinical Research
This module forms part of the Graduate Certificate in Cinical & Translational Research and the Graduate Diploma in Health Informatics. The goal of this module is to introduce students to key concepts in data management for clinical research. Specifically this…
Biorepositories for Clinical & Translational Research
This module forms part of the Graduate Certificate in Clinical & Translational Research. The goal of this module is to introduce students to key concepts in the collection, processing and storage of biological samples for clinical and translational research. Specifically,…
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…