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Session 3: Ethical Discussions In Pharmacovigilance
Session Chair(s)
Wendy Huisman, PHARMD
VP Quality and Patient Safety, Avanzanite Bioscience, Netherlands
Willemijn van der Spuij, MSC
Executive Director Europe | International - Patient Safety, Bristol Myers Squibb, Switzerland
At first sight, pharmacovigilance activities and its legislation seem black and white – at least that is what Industry and inspectors agree to disagree on. There are however different shades of grey and that is where dilemma’s come in. This session will not focus on changes in the legislation. Instead, we would like to get into the ethical dilemma’s that arise in the grey zone; between the boundaries of the legislation / providing medicinal products / providing APIs on one hand and patient needs and patient safety on the other hand.
“Is it preferable to do nothing or to take action even if the outcome is disruptive to current regulations?”
This session aims to take the audience on a reflective journey outside of the ‘regulatory comfort zone’ in which we often operate and instead stimulates participants to think and discuss safety activities at a different level.
Speaker(s)
Introduction on Ethics: How to Deal with Ethical Dilemmas?
Professor of Medical Ethics, Hasselt University, Belgium
Automating Extemporaneous API Preparations for Custom Dosage Manufacturing at the Primary Care
CCO, DOSER, Netherlands
Product Provision in Low Income Countries – From a Safety Perspective: How to Operate When It's a Gray Area
Executive Director Europe | International - Patient Safety, Bristol Myers Squibb, Switzerland
Contributing Panelist
Hospital Pharmacist, Production,, Catharina Ziekenhuis, Netherlands
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