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Session 2: Best Practices In Compliance
Session Chair(s)
Francoise Sillan, MD
EU1 UK QPPV, Ipsen, France
Wendy Huisman, PHARMD
VP Quality and Patient Safety, Avanzanite Bioscience, Netherlands
A Marketing Authorisation Holder in EU should have a Pharmacovigilance System and a Quality Management System (QMS). The QMS can be solely for PV, however generally is for all GxP functions within the company. Compliance is an important part of this.
The goals of audits and inspections are regulatory compliance monitoring and improvement. Among the numerous challenges there are the complexity of local regulations, complexity of Pharmacovigilance organization with numerous partnerships and subcontracting of activities to external vendors.
This session will give an overview on these challenges and (cross GxP) practical examples derived from audits and inspections and how the development of new technologies can support the preparation to successful Pharmacovigilance inspections.
Speaker(s)
Scene Setter: Survey on KPIs from Different Companies
VP Quality and Patient Safety, Avanzanite Bioscience, Netherlands
Risk Based Approach To Audit And Inspection (Company Perspective)
Senior Director, Pharmacovigilance QA, GSK, Belgium
Oversight: Striking the Right Balance with Vendors
Deputy EU QPPV Head, UK QPPV, Sandoz International GmbH, Germany
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