Our Assessment and Medical Evaluation of Individual Case Safety Reports is an interactive course designed to provide delegates with the necessary skills and knowledge required to assess individual case safety reports. You will assess reports from various sources both from a regulatory and a clinical perspective. Evaluation of a cluster of reports or case series will be discussed, in addition to guidance regarding the coding of certain types of events such as off label use. The course covers the current and future requirements for the production of case narratives, at an individual level and also within regulatory submissions such as periodic benefit risk evaluation reports. Practical coaching takes place in small groups where delegates have the opportunity to discuss individual cases and receive feedback from expert tutors. Outline: - Overview of data elements required for case narrative writing - Style and skill involved - Handling follow-up information - Dealing with difficult cases and special situations - Incorporating narratives into; Individual Case Safety Reports clinical trial study reports, periodic safety reports, regulatory summaries and research reports - Practical exercises in writing case narratives - Case narratives in the future, including 'auto-narratives' 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.
- Relate the complexity of medical history taking into account challenges faced in producing good quality case narratives - Define and appraise the critical data elements needed from reporting sources to complete a safety report - Critically analyse an individual adverse event as to whether it is reportable and provide recommendations as to whether reporting should be expedited