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Diederick Slijkerman EMACOLEX Budapest May 11-13

Implementation Plan for the Strategy of the EU Heads of Medicines Agencies 2011– 2015 www.hma.eu. Diederick Slijkerman EMACOLEX Budapest May 11-13. The Challenge. 76 paragraph Strategy document 50 Strategy objectives 23 Working Groups 5 years Informal Network EMA Roadmap 2015.

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Diederick Slijkerman EMACOLEX Budapest May 11-13

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  1. Implementation Plan for the Strategy of the EU Heads of Medicines Agencies 2011– 2015 www.hma.eu Diederick Slijkerman EMACOLEX Budapest May 11-13

  2. The Challenge • 76 paragraph Strategy document • 50 Strategy objectives • 23 Working Groups • 5 years • Informal Network • EMA Roadmap 2015 EMACOLEX Budapest

  3. 1. The HMA Strategy 2011-15 HMA Safeguarding Public And Animal Health Further Improving the Operational Efficiency of DCP/MRP Themes Supporting Innovation What does success look like? EMACOLEX Budapest

  4. The Big Ideas • Safeguarding Public and Animal Health • Strengthen risk-adaptive pharmacovigilance across the Network • Maintain quality and authenticity of products as manufacturing increasingly moves to third countries “Strengthened surveillance” “Quality and Inspections” EMACOLEX Budapest

  5. The Big Ideas • Supporting Innovation • Maintain Europe as a leader in clinical trials • Respond to the emerging issues of 2011-15 such as antimicrobial resistance, availability of medicines etc. “Clinical Trials” “Emerging Issues, New Technology” EMACOLEX Budapest

  6. The Big Ideas • Further Improving Operational Efficiency of DCP/MRP • Maintain DCP/MRP as the preferred route for product authorizations across Europe • Make the decentralized process work even better • Build and strengthen communication with Stakeholders • Optimize use of information technology across the Network “Best Practice” “Streamlining and Harmonization” “Good Communication” “Information Technology” EMACOLEX Budapest

  7. How To Get There ? EMACOLEX Budapest

  8. How To Get There ? • Organize business of HMA into work areas • Use existing Working Groups / Task Forces to implement specific objectives of Strategy • Designated lead for each work area • Set specific targets • Annual review process • Embed Strategy into joint Agenda EMACOLEX Budapest

  9. 1. Work Areas HMA Safeguarding Public And Animal Health Further Improving the Operational Efficiency of DCP/MRP Themes Supporting Innovation EMACOLEX Budapest

  10. 1. Work Areas Themes Work Areas EMACOLEX Budapest

  11. 2. Use Existing WGs for Strategy Objectives • (1) Coordination group for mutual recognition and decentralized procedures (human) • (13) EMACOLEX • (14) European risk management strategy facilitation group • (2) Coordination group for mutual recognition and decentralized procedures (veterinary) • (15) European surveillance strategy working group • (3) Pharmacovigilance – human • (16) EMA management board/HMA telematics committee • (4) Pharmacovigilance – veterinary • (17) HMA telematics support group • (5) Clinical trial facilitation group • (18) Office of training • (6) Benchmarking of European Medicines Agencies steering group • (19) Availability of medicines working group • (7) Working group of quality managers • (20) Report on task force on resources in MRP/DCP • (8) Working group of communications professionals • (21) EMA management board/HMA working group on transparency • (9) Working group of product testing • (10) Working group of enforcement officers • (22) Task force for improvement on veterinary legislation • (11) Homeopathic medicinal products working group (23) Task Force on Antimicrobial Resistance EMACOLEX Budapest (12) Strategy II Task Force

  12. 2. Key HMA Working Groups Quality and Inspections Emerging Issues New Technology Streamlining And Harmonization Strengthened surveillance Best Practice Information Technology Clinical Trials Good Communication WG of Product Testing WG of Enforcement Officers EU Veterinary Legislation Taskforce EMACOLEX Task Force on AMR Availability of Medicines Working Group Coordinated Group for Mutual Recognition and Decentralized Procedures (Human and Veterinary) Office of Training HMA Telematics Support Group European Risk Management Strategy Facilitation Group Clinical Trials Facilitation Group Benchmarking Of European Medicines Agencies Steering Group Working Group of Communication Professionals Pharmacovigilance (Human and Veterinary) HMA European Surveillance Strategy WG EMACOLEX Budapest

  13. 3. Designated Leads For Work Areas Quality and Inspections Emerging Issues New Technology Streamlining And Harmonization Strengthened surveillance Best Practice Information Technology Clinical Trials Good Communication Work Area Leads EMACOLEX Budapest

  14. 3. HMA Work Area Leads • Overall responsibility for delivery of goals within a work area • Liaise with Working Groups on defining and achieving specific objectives of work area • Work with MG/PS on the allocation of slots for Working Groups to present as necessary at HMA Summits • Facilitate collaborative working across work areas to achieve HMA objectives… • May be an existing Mentor of a relevant Working Group EMACOLEX Budapest

  15. 3. HMA Leads For Working Groups EMACOLEX Budapest

  16. 4. Set Specific Targets / Deliverables • For example (for illustration only…): • Target date for common HMA portal • Target to reduce referrals arising from DCP • Target for voluntary decentralized process for clinical trials applications and implementation of VHP • Target date and plan for HMA website • Target for improving variations in spontaneous ADRs across Network • Training – harmonization and exchange programme EMACOLEX Budapest

  17. 5. Annual Review • Review progress and priorities • Respond to emerging issues and events • Review targets and set new ones • Review can occur at last HMA meeting of year EMACOLEX Budapest

  18. 6. Embed Strategy into Joint Agenda • Announcements, Updates • Safeguarding Public and Animal Health • Strengthened surveillance • Quality and Inspections • 3. Supporting Innovation • Clinical Trials • Emerging Issues, New Technology • 4. Operational • Efficiency • Best Practice • Streamlining and Harmonization • Good Communication • Information Technology • Other Standing Agenda Items • E.g. Stakeholder liaison • 6. AOB EMACOLEX Budapest

  19. 6. HMA Agenda – Allocation of Slots Work Area Lead Working Group Working Group Working Group MG/PS Presidency Working Group Working Group Agenda Working Group EMACOLEX Budapest

  20. 6. Agenda Setting – Collaboration 2011 2012 HMA Agendas EMACOLEX Budapest

  21. Summary • HMA Business • Eight work areas • Lead for each work area • Specific targets • Annual review • HMA Working Groups • Will retain responsibility for practical delivery of work areas under HMA guidance • HMA Agenda • Strategy embedded into joint Agenda EMACOLEX Budapest

  22. EMACOLEX - proposals • Rules of procedure: everyone setting out a questionnaire, presents the results at the EMACOLEX meeting • Reporting on a yearly basis to Aginus Kalis/HMA • Report containing oversight of all questionnaires and questions made in the EMACOLEX email network • Report of database on court cases (UK) • Responsibility of each chair to deal with this EMACOLEX Budapest

  23. EMACOLEX - action • How to proceed? • Making visible the use of EMACOLEX • The need of some structure in relationship with HMA • Plan of action EMACOLEX Budapest

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