Risk Management is the smart route to safety and to well aimed investment

In the increasingly competitive Life Sciences sector, spotting potential risks before they become a danger to the patient is a must and has just been enforced by new regulations (e.g. Volume 9a).  So, how can life science companies both manage risk and manage the regulator?

The traditional approach of pure compliance to regulations using a typically paper heavy system will probably keep you on the right side of the regulators - but, will it help you to improve your processes?  The public demands a demonstrable increase in safety.  No wonder the regulators are looking for a new approach!

The traditional approach does not increase safety, so much as encourage risk.  Nor does it deliver better or faster drug development - which ought to be on of the required outputs.  The defect of the traditional approach is that, though it uses immense resources, it addresses the letter but not the spirit of the regulations.  Yet the opportunities are there.

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

Manage risk manage the regulator.pdf