Increased regulations and worried consumers are just two of the factors driving trends in drug safety and risk management today

Heads of Pharmacovigilance (PV) are currently undergoing something of a rite 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: DS teams have to prove they have a structured approach to mitigating risk in place.  If not, the regulators are ready to enforce the penalties strongly.

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Drug Safety Grows Up

For further information please contact Kate Adams at kate.adams@wcigroup.com