PSURs can be seen as a time consuming exercise or as a positive step towards proactive pharmacovigilance.  Chris Holmes explains how to stay one step ahead...

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 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 that it pays to be more proactive in their pharmacovigilance efforts.  Bayer, for example, has taken the decision to compile Periodic Safety Update Report (PSURs) on 60 or so of its strategic drugs every six months, rather than adhere to the timetable of the regulatory authorities. 

This decision has taken significant resources to implement, but it provides a continuous process of safety evaluation and a 60% reduction in the cost of producing each PSUR.  The extra costs come from implementing 'smarter' drug safety processes to simplify activities, improve productivity, and provide better quality information to both the affiliate companies and the regulators.

To view the article in full, please click on the pdf link below:

The first rule of pharma.pdf