European Medicines Agency re-organisation
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1 European Agency re-organisation ing the work of the committees Presentation to the PCWP/HCPWP joint meeting 25 September 2013 Presented by Isabelle Moulon Head of Patients and Healthcare Professionals An agency of the European Union
2 New organisation structure to focus on three key elements Better support the scientific work of the EMA committees Better share the knowledge and information the Agency holds throughout the European Union (EU) medicines regulatory network Better meet the needs of our stakeholders and partners. 1 European Agency reorganisation
3 New organisation structure: reason why Reshaping a regulatory agency fit for the future Economic pressures New challenges, e.g. future legislative and policy challenges To do more with less: a more effective and efficient use of existing resources 2 European Agency reorganisation
4 New organisation structure 3 European Agency reorganisation
5 New organisation structure - main changes Creation of four new s dealing with medicines for human use Human Research & D Human E & B Inspections & Human P New for stakeholders and communication to provide improved coordination of the Agency s relations with stakeholders No change for the current entities responsible for veterinary medicines, and administration Advisory functions, which provide advice the on operational and scientific issues in their fields of expertise. 4 European Agency reorganisation
6 Human Research & D D-DS Advice D-DS-SCA Paediatric D-DS-PME Orphan D-DS-OME & D-RE D-RE-REA D-RE-EVD Governance ED-CG Human E & E-SR Anti-infectives & Vaccines E-SR-AIV CNS & Ophthalmology E-SR-CNS Endocrinology, Metabolism & Cardiovascular E-SR-ECV Oncology, Haematology & Diagnostics E-SR-ONC Rheumatology, Respiratory, Gastroenterology & Immunology E-SR-RGI Risk Review E-SR-RMR Specialised Disciplines E-SD E-SD-SSP E-SD-QME Non-clinical E-SD-NCS Pharmacology E-SD-CPH Biostatistics/ Pharmacoepidemiology E-SD-BPH of the ED-EXO B-PM B-PM-EVA B-PM-SAF Referral B-PM-REF Administrative B-PM-ADM Validation B-PM-VAL ED & B Committee B-CS Committees B-CS-SCS Working Parties B-CS-WPS B-BD-ASU Access to Documents B-BD-ATD B-BD-PIQ & B-BD Chief Policy Adviser AF-CPA & B-BD-BUS Collection & B-BD-DCM base B-BD-DBM Analysis B-BD-DAT & Inspections P-CI Manufacturing & P-CI-MQC & Non-clinical P-CI-CNC Parallel Distribution & Certificates P-CI-PDC Senior Medical r AF-SMO Inspections & Human P P-PH Signal P-PH-SMA Monitoring & Incident P-PH-MIM Design Board AF-PDB V V-VM & of V-VM-DEM & Organisational V-VM-ROS Animal & Public Health V-VM-APH Patients & Healthcare Professionals S-PHP -related to the Network S-PHP-PIN External & Press S-COM-PRX Centre S-COM-ICR International Affairs AF-INT Stakeholder & S S-COM Stakeholders S-CSO SME S-CSO-SME Web S-COM-WEB Requests for S-COM-RFI Audit AF-AUD Operations I-OP Customer I-OP-CUS Centre I-OP-DTC Unified s I-OP-UCM Control and Testing I-OP-QCT Legal AF-LD Technology I I-DV & Process I-DV-BPA Solution I-DV-SOL & Maintenance I-DV-ADM Project Managers I-DV-PRM I-DA, Standards & Modelling I-DA-ASM Warehousing, and Analytics I-DA-BIA Provisioning I-DA-DTP I-DA-DPM Liaison I-ILO Enterprise I-EAO I-O PMO I-PMO Human Resources A-HR Personnel A-HR-PER Training & Professional A-HR-TPD Staff Payments A-HR-SPO Finance & Budget A-FI Accounting A-FI-ACC Budget A-FI-BUD Verification A-FI-VFO *Deputy DED Administration A *The Deputy also serves as Head of Administration A-MM Organisation A-MM-MCO Financial A-MM-FSS Infrastructure A-IS Building A-IS-BDS A-IS-BSU Human Research & D-DS Advice D-DS-SCA Paediatric D-DS-PME Orphan D-DS-OME D & D-RE D-RE-REA D-RE-EVD Governance ED-CG Human & E-SR Anti-infectives & Vaccines E-SR-AIV CNS & Ophthalmology E-SR-CNS Endocrinology, Metabolism & Cardiovascular E-SR-ECV Oncology, Haematology & Diagnostics E-SR-ONC Rheumatology, Respiratory, Gastroenterology & Immunology E-SR-RGI Risk Review E-SR-RMR E Specialised Disciplines E-SD E-SD-SSP E-SD-QME Non-clinical E-SD-NCS Pharmacology E-SD-CPH Biostatistics/ Pharmacoepidemiology E-SD-BPH of the ED-EXO B-PM B-PM-EVA B-PM-SAF Referral B-PM-REF Administrative B-PM-ADM Validation B-PM-VAL ED & B Committee B-CS Committees B-CS-SCS Working Parties B-CS-WPS B-BD-ASU Access to Documents B-BD-ATD B-BD-PIQ & B-BD Chief Policy Adviser & B-BD-BUS Collection & B-BD-DCM base B-BD-DBM Analysis B-BD-DAT AF-CPA & Inspections P-CI Manufacturing & P-CI-MQC & Non-clinical P-CI-CNC Parallel Distribution & Certificates P-CI-PDC Senior Medical r AF-SMO Inspections & Human P Unified s P-PH Signal P-PH-SMA Monitoring & Incident P-PH-MIM Design Board AF-PDB V V-VM & of V-VM-DEM & Organisational V-VM-ROS Animal & Public Health V-VM-APH Advisory functions Patients & Healthcare Professionals S-PHP -related to the Network S-PHP-PIN External & Press S-COM-PRX Centre S-COM-ICR International Affairs AF-INT Stakeholder & S S-COM Stakeholders S-CSO SME S-CSO-SME Web S-COM-WEB Requests for S-COM-RFI Audit AF-AUD Operations I-OP Customer I-OP-CUS Centre I-OP-DTC I-OP-UCM Control and Testing I-OP-QCT Legal Technology I I-DV & Process I-DV-BPA Solution I-DV-SOL & Maintenance I-DV-ADM Project Managers I-DV-PRM AF-LD I-DA, Standards & Modelling I-DA-ASM Warehousing, and Analytics I-DA-BIA Provisioning I-DA-DTP I-DA-DPM Liaison I-ILO Enterprise I-EAO I-O PMO I-PMO Human Resources A-HR Personnel A-HR-PER Training & Professional A-HR-TPD Staff Payments A-HR-SPO Finance & Budget A-FI Accounting A-FI-ACC Budget A-FI-BUD Verification A-FI-VFO *Deputy DED Administration A *The Deputy also serves as Head of Administration A-MM Organisation A-MM-MCO Financial A-MM-FSS Infrastructure A-IS Building A-IS-BDS A-IS-BSU The start of a journey The Agency will be looking at all operations over the course of next months to design processes and refine structure. The transition to the new structure started on 1 August 2013 The new structure and revised operational processes will be completed in 2014 Advisory functions Throughout the transition period we will ensure continuity of operations for medicine evaluation and supervision 5 European Agency reorganisation
7 What it means for now The continuity of the EMA s operations will be ensured at all times during the period of reorganisation. All contact points will remain unchanged for the time being. Any changes that will be made will be communicated to the EMA s stakeholders. 6 European Agency reorganisation
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