DIA 2020 Virtual Global Annual Meeting

Component Type: Session
Level: Intermediate

Oversight is essential to assure that pharmacovigilance processes remain in a state of control, responsibilities are being performed as assigned, and that the quality management system supporting pharmacovigilance is effective. Effective oversight is an ongoing monitoring activity that looks at processes end-to-end, verifying that they are designed well and executed in a consistent and systematic way. Feedback loops from oversight activities are essential to drive continuous improvement. Oversight approaches must advance to keep up with the ever-increasing complexity of pharmacovigilance activities as well as the new opportunities presented by technology. Quality assurance auditing, the classic oversight tool, is evolving to leverage technology to be both more effective and efficient. Continuous evaluation of process performance, end-to-end through communication of safety information via labeling, is critical to assuring the correct linkages and that the process is always completed as expected. Assessing the external landscape and using the intelligence obtained provides and important way to check that the pharmacovigilance system is complete and stanards are aligned with current expectations. This session will cover how different approaches can contribute to a robust oversight model across the continuum of pharmacovigilance activities.

Learning Objectives

Recognize innovations in quality oversight through remote audit techniques; Describe how regulatory intelligence can be leveraged as a strategic compliance advantage; Identify how the Company Core Data Sheet (CCDS) can be manage to assure that safety information is consistent and complete globally.

Chair

David William Fryrear, MS

Speaker

Robust Regulatory Intelligence: A First Step Towards Compliance
Marina Suvakov, MS

Quality Oversight of Pharmacovigilance Processes by Technology Driven Remote Audits
Gaurav Shah, PharmD, PhD

CCDS or Local Labeling, a Chicken-and-Egg Situation? The Dilemma of the Product Reference Information Across the Consistency
Luca Cariolato, PhD, MSc