伦敦卫生及热带医学学院

Overview

Postgraduate Professional Development Short Course (30 credits)

The global challenge of maximising drug safety yet maintaining public confidence has become increasingly complex. Health authorities are tasked to provide quality care while managing a growing drug budget. Regulatory authorities must balance the potential benefits of new drugs with the perception of their potential harm.

This Postgraduate Professional Development Short Course addresses the need for well-informed professionals to work in all areas related to the assessment of drug safety and the management of risks and benefits of medications, including vaccines.

This course is run in collaboration with University of London, and applications must be made via the University of London website.

Who is it for?

This course is aimed at personnel involved in the safe use of medicines, particularly in developed countries. This includes those working (or intending to work) in: the pharmaceutical industry who are involved in drug development, licensing and surveillance; regulatory bodies who are involved in licensing and surveillance; the health service who are involved in drug policy; and health policy decision-making agencies.

Course objectives

This course aims to equip you with a basic understanding of the concepts and practice of pharmacoepidemiology and pharmacovigilance, and to apply these skills to a currently unresolved drug safety issue.

By the end of this course, you will be able to:

• Demonstrate an understanding and critically evaluate issues surrounding the risks and benefits of drug use in humans including the cause, manifestations and consequences of adverse drug effects (ADEs), the manner in which these are detected and monitored, and the related historic and legal frameworks
• Understand and critically compare fundamental statistical, economic and epidemiological concepts and methods
• Understand and critically reflect upon important pharmacoepidemiological concepts and methods and how these methods can be applied to specific drug issues
• Assess and critically analyse the results of pharmacoepidemiological studies, including critical appraisal of the study question, study design, methods and conduct, statistical analyses and interpretation
• Understand how new medicines are assessed for their cost-effectiveness as well as efficacy and safety, before being recommended for use
• Apply the techniques and approaches covered in the taught element of the course, plus your own experience, to evaluate issues presented to you in the format of a project, and where relevant, develop recommendations for the best option or options.