Pharmacovigilance Workshop

Dear all

Here is a draft outline of what we think may be useful for a day’s workshop on Pharmacovigilance.  It would be really helpful to have your feedback and suggestions of what you may want to have training on in such a workshop.  Different CTUs have different systems and also may have experienced something different whilst having an inspection, so such a day would provide the ideal opportunity to share ideas and good practice.

 During the day we may be able to deliver some or all of the following topics.

It would be really helpful to know if you or someone else from your unit are likely to attend such a workshop.

Many thanks, best wishes, Joanna

•  Basic definitions of AE, SAE, SAR, SUSAR  (both for CTIMPs and nonCTIMPs)
•  Difference between event term, signs and symptoms
•  What does Assessment of causality involve?
•  Challenges of assessing events in terms of the underlying disease and the intervention  (with real examples)
•  Challenges of combination interventions
•  The process of reviewing SAEs:  explore upfront how different CTUs perform this activity
•  Need for independent SAE review?  What should be considered when making such a decision?
•  Assessment of expectedness in relation to interpretation of the RSI
• DSMC: what role do they play? (may do a role play)
• Processing safety data including coding
• DSUR and the challenges of blinded trials
• Safety database vs clinical database:  explore what systems people use and what needs to be considered.

 

Joanna Black

[Author]

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