Thursday September 29th @10am EDT

 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 with 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 Amicus’ path from a CAPA, emphasizing their:

  • Need in moving from a manual to a validated, automated system
  • Selection process
  • Experience with Orbit overall
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. Orbit takes 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. Our approach is highly collaborative in aligning the process and system. Join presenters Christina Wagner of Orbit and Zina Sadeq of Amicus, as Zina highlights their entire experience from dealing with a CAPA, to their system selection process, and the hands-on approach to PVAs with the Orbit team.

Meet the Presenters

Zina Sadeq

Director, Regional PV &
Alliance Management

Christina Wagner

Account Manager