From 01 April 2020 to 31 March 2021, the MHRA’s Good Pharmacovigilance Practice Inspectorate (GPvP) conducted 37 pharmacovigilance (PV) inspections on 36 marketing authorisation holders (MAHs) to evaluate its PV processes and compliance with existing EU and national PV regulations.
Read MoreUtilisation of artificial intelligence (AI) to transform key steps in clinical trials to increase clinical trial efficiency, improve patient safety and the patient experience.
Read MoreA pharmacovigilance perspective on the Cumberlege Report…
Read MoreThe evolution of patient registries for pharmacovigilance.
Read MoreA look at four areas where contingency plans are urgently needed to Brexit-proof your PV system.
Read MoreA look at four areas where increased cross-functional collaboration and understanding can yield benefits, both immediately and also downstream.
Read MoreVery grateful to PIPA allowing me to publish the full article here, so non-members can see it.
Read MoreSodium valproate has been in the news recently due to its links to birth defects and the pregnancy prevention programme (PPP), introduced in April 2018, to limit its use in women and girls of child bearing potential. These risks were known when I first started working in PV, over 10 years ago, so I was surprised to see it making such big headlines. How has a well-established side-effect only recently come to the public attention, casting the industry in further bad light? This is not a piece about sodium valproate specifically, but rather the general process of risk management and communication between the industry, regulators and the public.
Read MoreThe EMA recently released it's two-year report on the PRIority MEdicines (PRIME) scheme...
Read MoreSee the latest edition of PIPELINE for my thoughts on the utilisation of social media data in pharmacovigilance…
Read MoreAfter years of saying I’d do it (and a bit of a holiday since finishing my last role), I’m delighted to formally launch Drive Phase PV…
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