In late 2018, the EMA published further guidance (Product - or Population‑Specific Consideration IV: Paediatric Population) for review of paediatric safety data in regulatory documents.
The revised guidance, which is not stand-alone and operates within the context of existing GVP Modules I to XVI, was necessitated by a number of important changes... Read More
Despite the uncertainty flowing from the UK’s ongoing constitutional upheavals, PV medical writing is here to stay! The safety of medicines continues to be rigorously tested and monitored throughout their lifecycle, irrespective of national or international borders.
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