OCTRU Pharmacovigilance Workshop *ONLINE*
Tuesday, 08 February 2022, 10am to 4pm
Hosted by firstname.lastname@example.org
Workshop key objectives:
Understanding the terms diagnosis, signs and symptoms; and investigations
Assessment of causality: the rules within the framework
Assessment of expectation: when is an event considered expected?
Downgrading of SUSARs: when is this allowed?
Query of SAEs
Interpretation of the RSI
Managing updates to the RSI
Coding and the use of MedDRA
Working through some real examples of SAEs
Note: the workshop is focused on CTIMPs, but several aspects of this are relevant to nonCTIMPs. It will
not cover the rules for Medical Device trials.
To book your place, please email email@example.com