How people and culture leaders are creating a competitive and…
How has the pandemic been helping PV to integrate the patient centricity model?
How to manage data sets in order to create more effective safety strategies?
Before thinking how we will manage data sets, it is critical to know what safety concerns, question we would like to address. Based on the why we need these data sets, we will build the safety strategy to acquire them and ensure effective execution and analysis. In a nutshell, we must start with a very clear & well define safety strategy and then acquire or define how existing data sets could be managed.
What is in your opinion the key factor in the patient-centric approach in pharmacovigilance?
Pharmacovigilance is also patient safety; therefore patients are in the centre of all what we do every day in PV. Therefore, by definition PV must be patient centric. However, it is easier to declare than to act. PV should acquire a more patient-centric approach to improve the impact and effectiveness of the risk management plan and moreover the risk minimisation measures to ensure patient safety.
Listen from patient experience in their daily live, fighting for their health and dealing with their side effects would make a strong difference in PV activities.
Being Patient-centric is now what PV must be.
How do you see the near post-pandemic future of pharmacovigilance and risk management?
The pandemic democratized the PV and risk management. Now, patient, people know what PV mission is and what they must expect from the pharma industries, regulators in term of patient safety. The pandemic pushed all PV’s stakeholders to be more proactive, be more patient-centric. I really see the pandemic as a great opportunity to make PV evolving toward a real differentiator factor. In the near future, even tomorrow, we as PV experts & leaders would have to fully integrate the patient centricity model in our risk management plans; the safety strategies are also evolving we should go beyond the regulatory requirements and propose new ways to ensure patient safety.
Clemence Elie is a VP, Head of Global Patient Safety, dQPPV at Ipsen. She is passionated by medical science and technology & people development. People and patient centricity is what drives her while working in the pharmaceutical industry.
With almost 20 years of pharmaceutical industry experience, Clemence have been able to acquire & develop strong experience and expertise in Pharmacovigilance as well as in Human resources.
Spending 15 years to ensure patient safety, she had the opportunity to lead major transformation journey, by restructuring and rebuilding PV-Systems platforms, setting-up PV outsourcing strategy, streamlining safety processes and tools and building effective safety strategies in a hilghly cross-functional, matrix environment.
Clemence holds a Pharmacist Degree from Claude Bernard University and an Executive MBA from EM Lyon Business School.