Simplifying Global Compliance
With this report you’ll gain understanding of new EU pharmacovigilance rules, from preapproval through the life of a drug, plus insight into compliance in a new era. Specifically you’ll discover:
- How to deal with the PRAC
- How to tailor a PRAC-ready pharmacovigilance system, including finding and appointing a new “qualified person” (QP) to oversee pharmacovigilance
- How to adapt to broad new definitions of adverse drug reactions, including monitoring of off-label uses and misuses
- How to prepare for safety label warning changes to accompany products whenever a regulator requests additional safety monitoring
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