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INNOVATIVE APPROACHES TO PRODUCT INFORMATION FOR PHYSICIANS AND PATIENTS
Session Chair(s)
Lisette Vromans
Ass Director Regulatory Liaison Regulatory policy EU & MOW
Merck Sharp & Dohme, Netherlands
Are today’s package leaflets a betrayal of European patients? This session will provide stakeholders views on how the SmPC and Package Leaflet can be made fit for the future and for purpose. Patient/physician needs will be at the center of this session. Regulators will be invited to explain their ideas for future options to create better SmPCs and better Package leaflets and the steps needed to get there. And industry will show their concept on how to make product information useful communication tools to enable better outcomes and possibly contribute to improving health literacy by using innovative technologies (electronic leaflets, visualisations).
Speaker(s)
Patient Perspective on what is needed to make the patient leaflet a communication tool
Nicola Bedlington
European Patient's Forum, Belgium
Special Advisor
Improving information for patients and healthcare professionals: View of a Regulator
Jan MacDonald, MSc, RPh
MHRA, United Kingdom
Group Manager for AIMS
The Way Forward: From package leaflets towards electronic product information tailored to the individual need of patients and healthcare professionals
Gesine Bejeuhr, PharmD
Bayer AG, Germany
Pediatric Regulatory Leader
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