Assessment and Medical Evaluation of Individual Case Safety Reports (Hybrid Event)

Course Overview

Our Assessment and Medical Evaluation of Individual Case Safety Reports (ICSRs) is an interactive course designed to provide you with the necessary skills and knowledge required to assess ICSRs. You will review reports from various sources both from a regulatory and clinical perspective as well as understand medical review of Individual Case Safety Reports for causality and seriousness purposes. Evaluation of a cluster of reports or case series will be discussed, in addition to guidance regarding MedDRA coding of certain types of events and special situations such as off label use, as well as reports from literature and management of third parties.

The course covers the current and future requirements for the production of case narratives, at an individual level and within regulatory submissions such as periodic benefit risk evaluation reports. Importantly, the course provides a detailed view of the journey of an individual case safety report from receipt to submission. Practical coaching takes place in small groups where delegates have the opportunity to discuss individual scenarios and receive feedback from expert tutors from Regulators and Industry.

As well as being suitable for those new to ICSRs, the course will cover up-to-date information making it a good refresher for those with more experience.

*Please note that the course dates and programme may be subject to change.

The in-person session of this course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified at least three weeks prior to the course.