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Session 3: Anchoring The PV System in Times of Transition
Session Chair(s)
Angela Van Der Salm, PhD, MSc
Director PV, Managing partner, DADA Consultancy B.V., Netherlands
Willemijn van der Spuij, MSc
Executive Director Europe | International - Patient Safety, Bristol Myers Squibb, Switzerland
Session Overview This time, our oversight session will focus on the challenges of aligning pharmacovigilance systems with evolving business realities. We will examine PV system changes and governance under the pressure of organizational transformation. In times of change, the role of the QPPV is to safeguard system stability - ensuring not only regulatory compliance, but above all, the continued protection of patient safety by keeping the PV system robust and reliable through periods of change. We will look at what a QPPV must do to remain rock-solid in turbulent weather until skies turn blue again.
Speaker(s)
Laying the Foundations: When Does a Company Need a QPPV
Hanne Gjeding Miles
Director, Global Drug Safety & PV Compliance, Genmab A/S, Denmark
Setting Up a PV System from Scratch
Lilit Khatchikian
Global PV Risk Minimization Physician & Deputy EU/UK Quality Person - PV, Galderma, France
Impact of Divestitures and Restructuring
John Poustie
Head of Consumer Safety Global Operations, Haleon, United Kingdom
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