Periodic safety update reports can be seen as a time consuming exercise or as a positive step towards proactive pharmacovigilance

No-one likes reporting bad news, especially when it can lead to the withdrawal of a product.  Equally, everyone knows it is better, particularly in pharmaceuticals to play it safe.  This ambivalence is squared in most companies by simply doing what is required by law.

But current regulations are not easy to comply with and some firms are finding it pays to be more proactive in their pharmacovigilance efforts.  Bayer, for example, has taken the decision to compile periodic safety update reports (PSUR) on 60 or so of its strategic drugs every six months rather than adhere to the timetable of the regulatory authorities.

To read the paper in full please click on the pdf link below:

The first rule of pharma