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Session 4: QPPV Oversight and Data Integrity
Session Chair(s)
Katarzyna Swiderek, MPharm, RPh
Director, Safety Evaluation Risk Management (SERM)
GlaxoSmithKline, Poland
Angela Van Der Salm, PhD, MSc
Director PV, Managing partner
DADA Consultancy B.V., Netherlands
In this session, we are investigating the QPPV oversight role when it comes to data rather than processes. How reliable are the data listings that end up in your PSMF? What tools can you use to appropriately monitor your risk minimisation and pharmacovigilance activities? And how to cope with the requirements posed by the General Data Privacy Regulation with regards to the processing of personal data?
Speaker(s)
GDPR
Christopher J. Foreman, JD, LLM
Merck Sharp & Dohme (Europe) Inc., Belgium
Deputy Chief Privacy Officer, Global Privacy Office
Tracking and Implementation of PASS and of Risk Minimization Measures (RMM)
Joanne Emmott
MSD, United Kingdom
EU QPPV Deputy
PSMF Listings
Wendy Huisman, PharmD
Vigifit, Netherlands
Director
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