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Session 4: The QPPV Role in Manufacturing and Quality Issues
Session Chair(s)
Elspeth McIntosh, MBA, RN
Director, Castle Pharmacovigilance Ltd, United Kingdom
Katarzyna Okrojek-Swiderek, MPHARM, RPH
Scientific Director, Safety Evaluation Risk Management (SERM), GlaxoSmithKline, Poland
The PV Quality system is an integral part of the PV system, but QPPVs also need to have an understanding of wider quality issues and of safety considerations from other disciplines. As innovative products have entered mainstream use, regulations become increasingly more complex, and expectations for PV become greater and more stringent, we provide an overview of some of the quality and GMP topics that should be considered as part of the QPPV oversight.
Speaker(s)
Monika Pietrek, MD, PHD, MSC
Managing Director and Senior Consultant, Pietrek Associates GmbH, Germany
Quality oversight and interactions with GMP
Jens-Ulrich Stegmann, MD, RN
Senior Vice President, Head Clinical Safety and Pharmacovigilance and EU QPPV, GSK , Belgium
The QPPV Perspective
Suzie Seabroke, PHD, MSC
Senior Pharmacoepidemiologist, Vigilance and Risk Management Division, MHRA, United Kingdom
Signal detection
Ruth Luther, MPHARM, RPH
Director, Pharmacovigilance Excellence , Astrazeneca UK Ltd, United Kingdom
Health Hazard Evaluation
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