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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
Wendy Huisman, PharmD
Avanzanite Bioscience, Netherlands
VP Quality and Patient Safety
Risk Based Approach To Audit And Inspection (Company Perspective)
Kristel Van De Voorde, MPharm
GSK, Belgium
Senior Director, Pharmacovigilance QA
Oversight: Striking the Right Balance with Vendors
Jean Kilgour-Christie, BSN, MSc
Sandoz International GmbH, Germany
Deputy EU QPPV Head, UK QPPV