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Session 4: QPPV Oversight and Data Integrity
Session Chair(s)
Katarzyna Okrojek-Swiderek, MPHARM, RPH
Scientific 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)
Christopher J. Foreman, JD, LLM
Deputy Chief Privacy Officer, Global Privacy Office, Merck Sharp & Dohme (Europe) Inc., Belgium
GDPR
Joanne Emmott
EU QPPV Deputy, MSD, United Kingdom
Tracking and Implementation of PASS and of Risk Minimization Measures (RMM)
Wendy Huisman, PHARMD
VP Quality and Patient Safety, Avanzanite Bioscience, Netherlands
PSMF Listings
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