Back to Agenda
Session 4: The QPPV Role in Manufacturing and Quality Issues
Session Chair(s)
Elspeth McIntosh, MBA, RN
Director
Castle Pharmacovigilance Ltd, United Kingdom
Katarzyna Swiderek, MPharm, RPh
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)
Quality oversight and interactions with GMP
Monika Pietrek, MD, PhD, MSc
Pietrek Associates GmbH, Germany
Managing Director and Senior Consultant
The QPPV Perspective
Jens-Ulrich Stegmann, MD, RN
GSK , Belgium
Senior Vice President, Head Clinical Safety and Pharmacovigilance and EU QPPV
Signal detection
Suzie Seabroke, PhD, MSc
MHRA, United Kingdom
Senior Pharmacoepidemiologist, Vigilance and Risk Management Division
Health Hazard Evaluation
Ruth Luther, MPharm, RPh
Astrazeneca UK Ltd, United Kingdom
Director, Pharmacovigilance Excellence
Have an account?