Preparing PBRERs for vaccines – what does the medical writer need to know?


by Admin

Having prepared PSURs for more years than I would care to admit, with experience from the old world of the Volume 9a PSUR to the more recent landscape of GVP Module VII and the EU PBRER, it has been striking to note the absence of discussion on preparation of PBRERs for vaccines, and the vaccine-specific considerations that analysis of these safety data requires!

It was therefore a great pleasure to write an article for the EMWA journal this year, to discuss these vaccine-specific considerations for PBRERs and share our group’s experience in this area.

Amongst other things, we discuss our approach to the expanded scope of data considered as medication/vaccination errors, the additional scope of published safety data for review in vaccine PBRERs, and analysis of vaccine anxiety-related reactions – all essential food for thought, if you’re a PV medical writer tasked with preparation of PBRERs for vaccines!

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