PVAs: Looking Beyond a CAPA with Zina Sadeq of Amicus Therapeutics

Pharmacovigilance Agreements (PVAs) with business partners require both companies to actively participate in the management of all things PV-related, to ensure timely and efficient delivery upon said commitments. This creates a tracking and oversight challenge of manual back-and-forth communications, actions, and acknowledgements of work. These home-grown systems are non-validated and in some cases, have led to company mandated CAPAs requiring a validated system. Zina Sadeq of Amicus Therapeutics is joining our webinar to discuss their path from a CAPA, emphasizing their:

• Need in moving from a manual to a validated, automated system
• Selection process
• Experience overall with Orbit

Orbit is a validated and automated system that guides your team from negotiating and drafting to actively monitoring PVAs with reminders, version comparison, and retirement workflows. We take a pragmatic approach to the many contributing factors involved in managing PVAs, which not only improves productivity but enables clear oversight and compliance of your terms and commitments. The Orbit Approach is highly collaborative in aligning the process and the system.