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Drug Safety Research Unit

Assessment and Medical Evaluation of Individual Case Safety Reports

Practical Information

Commencing Date:
tba
Language:
English
Location:
United Kingdom


Teaching Methodology:
Blended Learning


European Fees:
1190 GBP
Scholarship Possibilities:
No

Course Contact

Fiona Coxsell

eandt@dsru.org


Website

Drug Safety Research Unit

University Accreditation: No

Individual Course

Description

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.

Outcomes

- 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

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