Specialty Pharmacy's Increasing Role in Pharmacovigilance

Role of specialty pharmacy often requires pharmacovigilance compliance

Specialty Pharmacy's Increasing Role in Pharmacovigilance

The FDA’s and European Medicines Agency’s requirements for reportable information need to be understood by the specialty pharmacies in order to maintain compliance within the global regulatory landscape. For this reason, it is important to maintain a pharmacovigilance system that is comprehensive in its approach and meets these broad regulations.

Last week, UBC experts Kevin Cast, VP, Global Pharmaceutical Business Development, and Aaron Berger, Director, Biometrics and Pharmacovigilance, hosted a webinar on this very topic. Relying on a combined 34 years of experience in the areas of specialty pharmacy and pharmacovigilance, they expanded on the fact that pharmaceutical manufacturers are accustomed to using robust procedures and systems to support compliance with the pharmacovigilance regulations set forth by regulatory bodies around the globe. While pharmacies, on the other hand, have traditionally followed local state pharmacy law as it relates to reporting adverse events.

As their recent article in Specialty Pharmacy Times explains, specialty pharmacies are playing an increasing role in patient support and disease management programs.  This role requires compliance with the guidelines that exist in the global pharmacovigilance landscape.

Keep compliance top of mind and explore the intersection between global regulations governing adverse event reporting and operational considerations by viewing this informative webinar.