Case Study

Developing an Enterprise Roadmap to Post Authorization Safety Studies 

In their quest to ensure ongoing risk management, one top biopharmaceutical company needed to ensure compliance across its organization. With complex processes and legacy documentation in place around the organization, refining and streamlining operations was challenging. Additionally, they needed to implement and manage their post authorization safety studies (PASS).

This case study outlines how this organization partnered with Advarra Consulting Services and leveraged its team of experts to execute a phased approach to identify opportunities for improvement, analyze their current pharmacovigilance system state, and implement R&D industry best practices for regulatory compliance.

To learn how this organization achieved organization-wide compliance and managed its PASS, download the case study.

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CEU Credits

Certificate of Attendance

Time: 1 p.m. ET, 12 p.m. CT, 10 a.m. PT
Duration: 1 hour

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