I wanted to share some insights based on my recent interaction with one of our client’s PV colleagues.
As a UK-registered pharmacist and regulatory professional, patient safety is my top priority. It’s essential for the Marketing Authorisation Holder (MAH) to meet their legal obligations and ensure their product’s safety in the market.
However, I’ve observed that sometimes PV colleagues expand the scope of pharmacovigilance (PV) too broadly in the name of patient safety and MAH responsibility. This can inadvertently put the MAH at risk to fulfil their duty to patient safety.
As regulatory professionals, it’s crucial to challenge our PV colleagues when the scope is expanded beyond what is required and manageable under the regulations.
Remember, a stitch in time saves nine.