10th Annual Forum for Qualified Persons in Pharmacovigilance

This is the only forum designed for QPPVs by QPPVs, now in its 10th year and ever growing. This year’s objectives build on past successes and have been shaped by valuable feedback provided by participants of the past nine meetings. There is an enhanced opportunity for networking as the lectures are followed by a dinner.

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Session 5 Insights on Inspections, Audits and Quality Management: what’s it all about?

Session Chair(s)

Peter De Veene, MD

QPPV, MSD Belgium, Belgium

A robust Quality Management System is the foundation for a well-functioning PV system. This session will explore how latest developments in inspections and audits impact the QPPV role and what tools a QPPV can use to measure system performance. The auditing landscape is becoming more and more complex, as many companies are involved in several licensing relationships with many vendors providing services to multiple MAH´s. So how can the QPPV survive this auditing frenzy?

Speaker(s)

KPIs and Metrics as tool for the QPPV

Monika Pietrek, MD, PhD, MSc

Managing Director and Senior Consultant, Pietrek Associates GmbH, Germany

Switching from Regulatory Authority to Industry: a New Perspective?

Rebecca Webb

Director, Pharmacovigilance Quality Assurance, Abbvie, United Kingdom

Challenges of Partner Audits

Andrew Moore, PhD, MSc

Head QPPV and Alliance Office, Grunenthal Gmbh, Germany

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