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Session 2: QPPV Oversight - Deep Dive In Business Partners
Session Chair(s)
Katarzyna Swiderek, MPharm, RPh
Director, Safety Evaluation Risk Management (SERM)
GlaxoSmithKline, Poland
Kiernan Trevett, MSc
Principal Quality Lead, PDQ Quality Assurance Process GVP
Genentech, A Member of the Roche Group, United States
Angela Van Der Salm, PhD, MSc
Director PV, Managing partner
DADA Consultancy B.V., Netherlands
One of the main responsibilities of the QPPV is to ensure that the PV system under their responsibility is functioning as it should. QPPV oversight is therefore a recurrent topic in the QPPV Forum to share new insights and systems for ensuring this, especially relevant in the globalisation of PV systems and increased complexity with shared responsibilities between multiple business partners. This year, we dive deeper into oversight strategies for PV vendors and licensing partners, including key performance indicators and other measures outside of periodic audits.
Speaker(s)
Oversight from a CRO Point of View
Caroline Fitzsimons
IQVIA, Ireland
Associate Director, Local QPPV Network Oversight
QPPV Oversight where Non-EU License Partner is GSDB Holder
Yusuf Tanrikulu
Deutschland, Germany
PV System Oversight as a Process
Rory Littlebury
GSK, United Kingdom
Safety Governance Director