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Session 7: Risk Minimisation Measures And Digitalisation
Session Chair(s)
Maarten Lagendijk, MSc
Deputy EU QPPV, MSD, Netherlands
James Whitehead, MBA, MSc
Former Senior Director Device & Digital Safety - AstraZeneca, Visiting Lecturer - Pharmacovigilance MSc Course, University of Hertfordshire, United Kingdom
The pace at which technology is advancing is requiring Healthcare to transform. For pharmacovigilance, one of the key areas transforming is risk management and how risks are minimised. This is to address the expectations of healthcare professionals, the needs of patients and utilize technology to improve our ability to maintain safety.
With risks minimised in multiple ways, from communication through to remote patient monitoring, this session will present several case studies on what that transformation looks like. From Industry and Academics, you will hear what has gone well and what part of the transformation has not been as smooth. The session will finish with a panel where our academic and industry presenters will be joined by a regulator to discuss the digital risk minimsation transformation.
Speaker(s)
Koen Nauwelaerts, PharmD, PhD, MBA
Regulatory Policy and Innovation Lead, Bayer AG, Belgium
Transitioning from Paper to Electronic Distribution of DHPCs and EMs
Sharon Essink
PhD Candidate, Division of Pharmacoepidemiology and Clinical Pharmacology,, Utrecht Institute for Pharmaceutical Sciences, Netherlands
Studies to Evaluate the Effectiveness of Risk Minimization Measures – The Need for Speed
Thomas Goedecke, PharmD, PhD
Senior Pharmacovigilance Specialist, European Medicines Agency, Netherlands
General Update on Module XVI with Focus on Risk Minimisation Evaluation Methods (Addendum II)
Ryan Marshall
Risk Management Director, AstraZeneca, United Kingdom
Risk Minimisation Measure and Digital: Impact and the Strategy behind Digital
Priya Bahri, PhD
Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
With Additional Participation Of:
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