Increased regulations and worried customers are just two of the factors driving trends in drug safety and risk management today.  Examining the present situation, Deborah Gold at WCI Consulting Limited predicts a new, proactive pharmacovigilance environment for the future.

Heads of Pharmacovigilance (PV) are currently undergoing something of a rites of passage.  In the youth of their careers the focus for their Drug Safety (DS) teams was compliance with operational regulations.  And it worked.  Most Drug Safety teams now have both their compliance and their basic operational processes well under control.

However, times and regulations are changing.  The focus of the regulators has expanded to proving that DS teams have a structured approach to mitigating risk in place and, if not, they are ready to strong enforce the penalties. 

Worried consumers, alarmed by media reports of Big Pharma's rumoured preference for profits over patient safety, are adding to the call for the industry to take a wider and more proactive approach to PV.  The spotlight on safety is brighter than ever; and PV Heads are now required to take a more holistic view going forward, and find and develop opportunities for building safety into the wider drug development process.

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

Drug Safety Grows Up.pdf