An agency of the European Union 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 1

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 2

Focus efforts in three strategic areas 1.Addressing public-health needs 2.Facilitating access to medicines 3.Optimising the safe and rational use of medicines 3

How do we share our visions and strategic objectives? 1.Addressing public-health needs 2.Facilitating access to medicines 3.Optimising the safe and rational use of medicines 1.Enhancing medicines safety and access to medicines 2.Improving treatment outcomes of individual patients 3.Improving public health 4.Contributing to the efficiency and quality of health systems EMA PGEU 4

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

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 symbol Switch to non-prescription DHPCs and EMA safety communications etc… 6

EMA/PGEU synergies in handling current and future challenges –Patient safety and risk management –Prevention of medication errors –Falsified medicines –Supply shortage 7

European Medicines Agency engagement with Healthcare professionals is key in addressing public health challenges. 8 Conclusion