This module provides the student with the opportunity to develop competence in the logistical aspects of R & D, from the initial planning stage, through all aspects of organisation and management of the ongoing trial to its completion. Curriculum Content:…

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…

This module provides comprehensive information on pharmacovigilance and the existing regulatory requirements for the pharmaceutical industry and regulatory authorities at EU and international level. It explains the principles of pharmacoepidemiology and how these are used to evaluate drug safety in…

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…

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…

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…