Preparing PBRERs for vaccines – what does the medical writer need to know?
Having prepared PSURs for more years than I would care to admit, with experience from the old world of the Volume 9a PSUR to...
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Acadustri’s managing director publishes article on PV medical writing for vaccines
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Continue ReadingPV Writers’ Corner – An Oasis for all Safety Medical Writers!
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...
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New GVP guidance for paediatric data – how will this impact your process for PBRERs?
In late 2018, the EMA published further guidance (Product - or Population‑Specific Consideration IV: Paediatric Population) for review of paediatric safety data in regulatory...
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Acadustri House
It’s official! Thanks to our sustained growth from inception to date, we have acquired our new headquarters building to which we have recently moved! Yes, we’ve...
Continue ReadingAcadustri’s managing director presents lecture on the new PSUR
Dr Justina Orleans-Lindsay presents lecture on 'Periodic Safety Update Reports - an Introductory Overview' to students and industry professionals enrolled on the MSc/PgD/PgC in...
Continue ReadingAcadustri’s managing director publishes pivotal book on pharmacovigilance medical writing
Dr Justina Orleans-Lindsay's pivotal book, 'Pharmacovigilance Medical Writing: A Good Practice Guide', is intended to serve as a manual for pharmacovigilance professionals in all...
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