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Sharing Our Vision? A view from the European Medicines Agency. PGEU Symposium, 17 June 2013, Rome. Presented by: Guido Rasi Executive Director – European Medicines Agency. Challenging times. Economic and political pressure Need to do more, better, with less
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Sharing Our Vision?A view from the European Medicines Agency PGEU Symposium, 17 June 2013, Rome Presented by: Guido Rasi Executive Director – European Medicines Agency
Challenging times • Economic and political pressure • Need to do more, better, with less • Need to focus – core business – protect and improve Public Health • Status quo is not an option/ change will be permanent
European Medicines Agency reorganisation Re-shaping a regulatory agency fit for the future • Renewed focus on three key elements: • Support the scientific work of the EMA committees • Share the data the Agency holds and • Improve the way the Agency engages with and supports its stakeholders and partners: consolidation of interactions with patients and healthcare professionals
Focus efforts in three strategic areas • Addressing public-health needs • Facilitating access to medicines • Optimising the safe and rational use of medicines
How do we share our visions and strategic objectives? PGEU EMA • Enhancing medicines safety and access to medicines • Improving treatment outcomes of individual patients • Improving public health • Contributing to the efficiency and quality of health systems • Addressing public-health needs • Facilitating access to medicines • Optimising the safe and rational use of medicines
Working with stakeholders – interaction with healthcare professionals • EMA framework of interaction with healthcare professionals has been endorsed by the EMA Management Board • EMA has built a network of European organisations • So far 23 EU healthcare professional organisations are considered eligible and are publicly acknowledged in our website • An EMA Healthcare Professionals Working Party (HCPWP) has been established in June 2013
The reality of EMA-PGEU interaction • Membership of Pharmacovigilance and Risk Assessment Committee since April 2013 • Eligible organisation, member of the HCPWP • Regular involvement in: • Strategy and policies: EMA road map to 2015, transparency, etc… • Core business: Prevention of medication errors, Awareness campaign on black symbolSwitch to non-prescriptionDHPCs and EMA safety communicationsetc…
EMA/PGEU synergies in handling current and future challenges • Patient safety and risk management • Prevention of medication errors • Falsified medicines • Supply shortage
Conclusion European Medicines Agency engagement with Healthcare professionals is key in addressing public health challenges.