Drug Safety Research Unit

Description

Introduction Adverse Drug Reactions (ADRs) are a major clinical problem. An understanding of the clinical aspects of ADRs is a fundamental requirement for any professional in the field of pharmacovigilance. This course covers recognition and interpretation of ADRs and their underlying toxopathology and pharmacology. A panel of outstanding multi-disciplinary tutors will provide a comprehensive and up-to-date understanding of all aspects of ADRs through this interactive lecture-based course. Aims - To provide delegates with a grounding in and analysis of, the core principles of medical diagnosis including pattern recognition, and therapeutics - To analyse some of the core concepts of clinical pharmacology relevant to the conduct and interpretation of pharmacoepidemiological research - To review the mechanisms of drug action, the concept of drug potency, the role of pharmacodynamics and pharmacokinetics (including genetic and immunological factors) in determining variability in drug response and drug interactions - To review the classification of ADRs and pathophysiology according to body system and associated public health burden Programme features - Principles of medical diagnosis - Comprehensive and up-to-date understanding of medical and scientific aspects of ADRs - ADR examples - Overview of ADRs and interactions - Genetic and metabolic basis of ADRs - Immunological aspects of ADRs - ADRs by system organ class - Regulatory aspects including guidelines and causality assessment This course is offered as a stand alone short course, with CPD accreditation from the Faculty of Pharmaceutical Medicine, and as part of our postgraduate programme in pharmacovigilance in collaboration with the University of Portsmouth.

Outcomes

On completion of this course delegates should be able to: - Analyse the complexity of undertaking medical diagnoses and the influence of human behaviour (prescriber and patient) and drug factors important in therapeutic decision making - Critically examine the important features associated with Type A and Type B reactions and identify factors associated with individual susceptibility - Appraise the rationale for performing clinical investigations and the importance of correct interpretation of results

IMI Standards

• A predefined set of teaching objectives, leading to defined learning outcomes
• Assessment of the students' achievement in accordance with the agreed learning outcomes of the training offered
• A system for collecting, assessing and addressing feedback from learners, teachers, technical / administrative staff and programme / course / module managers
• Availability of appropriate and regularly reviewed reference material (e.g. published articles, links, book chapters, scripts, etc)
• Defined and transparent admission criteria
• Quality assurance of teaching staff
• Regular review of the QA/QC process and demonstration that the training is further developed in light of this review
• The facilities, infrastructure, leadership and competences available for the support of student learning
• University accreditation OR a system for approving, monitoring and reviewing the training offered