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Work programme 2017

WC500221614

Table of contents Part

Table of contents Part I: General context ................................................................................ 6 EMA priority areas and key influences ............................................................................ 6 Part II: Multiannual programming 2017–2019 .......................................... 12 Multiannual objectives ............................................................................................... 12 Multiannual work programme ..................................................................................... 15 Theme 1: Contributing to human health ...................................................................... 15 Theme 2: Contributing to animal health and human health in relation to veterinary medicines ................................................................................................................ 23 Theme 3: Optimising the operation of the network ........................................................ 30 Theme 4: Contributing to the global regulatory environment .......................................... 37 Part III: Work programme 2017 ............................................................... 42 Structure of the work programme ............................................................................... 42 1. Evaluation activities for human medicines ................................................................ 43 1.1. Pre-authorisation activities .................................................................................. 43 1.2. Initial evaluation activities ................................................................................... 48 1.3. Post-authorisation activities ................................................................................. 52 1.4. Referrals ........................................................................................................... 55 1.5. Pharmacovigilance and epidemiology activities ....................................................... 57 1.6. Other specialised areas and activities .................................................................... 61 1.7. Projects............................................................................................................. 63 2. Evaluation activities for veterinary medicines ............................................................ 66 2.1. Pre-authorisation activities .................................................................................. 66 2.2. Initial evaluation ................................................................................................ 68 2.3. Post-authorisation activities ................................................................................. 70 2.4. Arbitrations and referrals ..................................................................................... 71 2.5. Pharmacovigilance activities ................................................................................ 73 2.6. Other specialised areas and activities .................................................................... 74 2.7. Projects............................................................................................................. 78 3. Horizontal activities and other areas ........................................................................ 80 3.1. Committees and working parties .......................................................................... 80 3.2. Inspections and compliance ................................................................................. 83 3.3. Partners, stakeholders, communication and transparency ........................................ 87 3.4. International activities ........................................................................................ 93 3.5. Information management .................................................................................... 96 3.6. Projects............................................................................................................. 99 4. Support and governance activities ......................................................................... 101 Annexes .................................................................................................. 106 Annex 1: Activity based budget 2017 ........................................................................ 107 Annex 2: Financial resources .................................................................................... 108 Annex 3: Human resource needs and establishment plan ............................................. 109 Annex 4: Risks ....................................................................................................... 110 Annex 5: Procurement plan 2017 .............................................................................. 117 Annex 6: Organisational chart .................................................................................. 119 Work programme 2017 EMA/583016/2016 Page 4/123

Annex 7: Terms and abbreviations ............................................................................ 120 Work programme 2017 EMA/583016/2016 Page 5/123

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