natgillin/translations-raw huggingface dataset:
38/ 62 5. 5 Informationsteknologi Sektionen har til opgave af levere pålidelige og driftssikre informationsteknologiske tjenester (IT) til agenturet.
The sector’ s mission is to supply reliable and robust information technology (IT) services to the Agency.
Disse tjenesteydelser omfatter passende driftsstøtte, interne udviklingsaktiviteter og teknisk support til projekter med ekstern fokus.
These services include appropriate levels of operational support, internal development activities, and technical support for projects with an external focus.
EMEA vil påtage sig ansvaret for størsteparten af de paneuropæiske informationsteknologiprojekter og - tjenester fra januar 2003 i overensstemmelse med Europa- Kommissionens strategiforslag og gennemførelsesplan.
The EMEA has agreed to take on responsibility for the majority of the pan-European information technology projects and services with effect from January 2003 in accordance with a strategy proposal and implementation plan developed by the European Commission.
Dette er en betydelig ændring af agenturets IT- aktiviteter, som får konsekvenser i 2002 (når agenturet installerer de nødvendige strukturer og ressourcer for at kunne påtage sig de nye ansvarsområder) og i 2003, hvor EMEA konsoliderer ændringerne, som er foretaget i 2002, og påtager sig det fulde ansvar for de nye opgaver.
This constitutes a major change in the scope of the Agency’ s IT activities with consequences during 2002 (as the Agency puts in place the necessary structures and resources to assume the new responsibilities) and 2003, as the EMEA consolidates the changes effected during 2002 and takes on its new responsibilities in full.
Interne tjenester
Internal services
I løbet af 2002 planlægger IT- sektoren følgende aktiviteter:
During 2002, the IT sector will seek to achieve the following:
Funktion Operationel støtte
Function Operational support
Aktivitet - Sikring af en systemmindstetilgængelighed på 98% for IT- tjenesterne i EMEA' s officielle åbningstid
Activity - Ensure a minimum a minimum internal system availability of 98% of IT services during EMEA working hours - Provide helpdesk facilities in accordance with the levels of service required by the Agency
- Formidling af helpdesk- funktioner svarende til det serviceniveau, der kræves af agenturet
Applications & equipment Contribute to the business continuity/ disaster recovery project Equip and connect the 6th floor;
- Udskiftning af forældet udstyr og programmer i overensstemmelse med de definerede kriterier for produkternes livscyklus
- Execute the replacement of obsolete equipment and applications in accordance with the defined lifecycle criteria
Udskiftning af skærme; design og implementering af lagernet; fastlæggelse af en elektronisk lagerpolitik
Replace screens; design and implementation of storage area network; contribute to definition of an electronic archiving policy
Udvikling
Development -
- Opgradering af tilpassede applikationer i overensstemmelse med nye versioner af de underliggende mærkebeskyttede applikationer
Implement upgrades to customised applications as required by new releases of the underlying proprietary applications
Personaledatabase; Sincom 2 Database med videnskabelig
Personnel database; Sincom 2
- Udvikling og opgradering af specialprogrammer, som produceres i EMEA i henhold til de prioriteter, der er fastlagt af EMEA' s bestyrelse - Udvikling eller videreudvikling af nye programmer i overensstemmelse med de prioriteter, der er fastsat af EMEA' s bestyrelse
- Develop and implement upgrades to bespoke and customised applications in production at the EMEA in accordance with the priorities defined by EMEA management - Develop or continue the development of new applications in accordance with the priorities defined by EMEA management
hukommelse; database med videnskabelig rådgivning; database vedrørende lægemidler til sjældne sygdomme; ekspertdatabase; ActiTrak Mødestyringssystem
Scientific memory database; Scientific advice database; Orphan drug database; experts database; ActiTrak Meetings management system
Projektstøtte og - styring
Project support and management
- Teknisk support til udvikling og gennemførelse af større projekter
- Technical support in the development and implementation of major projects
PIM og eCTD; SIAMED; electronisk dokumentstyringssystem
PIM and the eCTD; SIAMED; electronic document management system
39/ 62 Europæiske initiativer og aktiviteter
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 European initiatives and activities
IT- sektionen vil yde støtte til følgende europæiske initiativer og aktiviteter
The IT sector will undertake the activities set out below in support of the European initiatives and activities
Initiativ EudraNet
Initiative EudraNet
Aktiviteter - Forberedelse til overtagelse af det operationelle ansvar fra januar 2003 - Ledelse af gruppen for teknisk implementering af EudraNet Telematics
Activities - Preparation for the assumption of operational responsibility from January 2003 - Chair of the EudraNet Telematics Implementation Group
EudraVigilance
EudraVigilance
- Operationel støtte til sikring af 99% systemtilgængelighed - Ledelse og støtte til de udviklingsansvarlige ved gennemførelsen af projektets fase 2 og 3, herunder den elektroniske gateway - Koordinering af testgruppen, heriblandt deltagere fra medlemsstater og industrisektoren - Formandskab i gruppen for teknisk implementering af EudraVigilance Telematics
- Operational support to ensure 99% system availability - Management and support of development contractors for the implementation of phases 2 and 3 of the project, including the electronic gateway - Coordination of the testing pilot group including participants from Member States and industry - Chair of the EudraVigilance Telematics Implementation Group
EuroPharm- database
EuroPharm database
- Teknisk support i forbindelse med specificeringen af datamodellen og brugerkrav - Teknisk support med henblik på at gøre datafeltdefinitioner tilstrækkeligt kompatible i samtlige paneuropæiske projekter - Teknisk support til prøveimplementeringen af databasen i samarbejde med den pågældende udvikler
- Technical assistance in the specification of the data model and user requirements - Technical assistance in ensuring appropriate compatibility of data field definitions across all pan-European projects - Technical assistance with the trial implementation of the database in conjunction with the nominated developer
- Teknisk hjælp og support i forbindelse med installeringen af systemer til modtagelse af elektroniske ansøgninger i overensstemmelse med eCTD - Teknisk hjælp og support ved definering og implementering af applikationer til administration af data, som er overført elektronisk - Teknisk hjælp og support ved definering og implementering af de applikationer, der kræves for at arbejde med data, som er overført elektronisk
- Technical assistance and support in setting up the necessary systems to receive electronic submissions in accordance with the eCTD - Technical assistance and support in the definition and implementation of the applications necessary to manage data that has been electronically submitted - Technical assistance and support in the definition and implementation of the applications necessary to work with data that has been electronically submitted
40/ 62 Bilag
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annexes
EMEA' s stillingsfortegnelse for 2000 – 2002
 EMEA 2002 Page 40/ 62
Sammendrag af EMEA' s budgetter for 2000 – 2002
EMEA establishment plan 2000 – 2002
2000
EMEA budget summaries 2000 – 2002
2001
3.
2002
4.
Bev
Profiles of EMEA personalities
Bevilget i 2001 Besat pr.
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 1 EMEA establishment plan 2000 – 2002
Bevilget i 2002
 EMEA 2002 Page 41/ 62
31. 12. 2000
2000
31. 12. 2001
Category and Grade
A1 A2 A3 A4 A5 A6 A7 A8
Occupied as at 31.12.2000
-- -- 4 24 22 25 23 --
Authorised for 2002
-- 1 5 29 27 25 24 --
-- -- 4
-- 1 4 26 24 24 24 --
-- -- 1 1 5 4
-- 1 5 29 28 29 30 --
-- 1 5
I ALT A B1 B2 B3 B4 B5 I ALT B C1 C2 C3 C4 C5 I ALT C D1 D2 D3 D4 I ALT D
A4 A5 A6 A7 A8 TOTAL A B1 B2 B3 B4 B5 TOTAL B C1 C2 C3 C4 C5 TOTAL C D1 D2 D3 D4 TOTAL D
98 3 4 6 5 5 23 13 13 37 -- -- 63 1 4 -- -- 5
24 22 25 23 -- 98 3 4 6 5 5 23 13 13 37 -- -- 63 1 4 -- -- 5
111 4 8 9 6 5 32 14 14 44 -- -- 72 1 4 -- -- 5
29 27 25 24 -- 111 4 8 9 6 5 32 14 14 44 -- -- 72 1 4 -- -- 5
103 4 8 9 5 5 31 14 13 42 -- -- 69 1 4 -- -- 5
26 24 24 24 -- 103 4 8 9 5 5 31 14 13 42 -- -- 69 1 4 -- -- 5
122 4 9 11 9 8 41 15 19 44 4 -- 82 1 5 -- -- 6
29 28 29 30 -- 122 4 9 11 9 8 41 15 19 44 4 -- 82 1 5 -- -- 6
STILLINGER I ALT
TOTAL POSTS
42/ 62 Fordeling af stillinger
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Allocation of posts
Direktionen i alt
Directorate total
Afdelingslederteam Sektionen for personale og budget Sektionen for infrastrukturtjenester Sektionen for bogholderi Reservestillinger
Head of Unit team Sector for Personnel and budget Sector for Infrastructure services Sector for Accounting Reserve posts
Afdelingen i alt
Unit total
2 10 17 6 2
2 10 17 6 2
2 11 19 7 --
2 11 19 7 --
Afdelingen for vurdering af humanmedicinske lægemidler før godkendelse Afdelingslederteam Sektionen for videnskabelig rådgivning og lægemidler
Unit for the Pre-authorisation Evaluation of Medicines for Human Use Head of Unit team
Sektionen for lægemiddelkvalitet Sektionen for lægemidlers sikkerhed og virkninger Reservestillinger Afdelingen i alt
Sector for Scientific advice and orphan drugs Sector for Quality of medicines Sector for Safety and efficacy of medicines Reserve posts
19 16 --
12 19 16 --
21 19 1
14 21 19 1
Afdelingen for vurdering af humanmedicinske lægemidler efter godkendelse Afdelingslederteam
Unit for the Post-authorisation Evaluation of Medicines for Human Use Head of Unit team
Sektionen for retsforskrifter og organisatorisk støtte Sektionen for lægemiddelovervågning og tilsyn med
Sector for Regulatory affairs and organisational support
lægemidlers sikkerhed og virkninger efter godkendelse
Sector for Pharmacovigilance and post-authorisation safety and efficacy of medicines
Reservestillinger Afdelingen i alt Afdelingen for veterinærlægemidler og tilsyn
Reserve posts Unit total Unit for Veterinary Medicines and Inspections
Afdelingslederteam Sektionen for veterinære markedsføringstilladelser Sektionen for veterinærlægemidlers sikkerhed Sektionen for tilsyn Reservestillinger Afdelingen i alt Kommunikations - og netværksafdelingen
Sector for Safety of veterinary medicines Sector for Inspections Reserve posts Unit total Communication and Networking Unit
4 8 7 14 --
7 14 --
4 10 8 14 --
8 14 --
Afdelingslederteam Sektionen for styring og offentliggørelse af dokumenter Sektionen for mødestyring og konferencer Sektionen for projektstyring Sektionen for informationsteknologi Reservestillinger Afdelingen i alt Reserve Stillinger i alt
Head of Unit team Sector for Document management and publishing Sector for Meeting management and conferences Sector for Project management Sector for Information technology Reserve posts Unit total Additional posts in general reserve Total number of posts
2 9 8 5 15 -- -- 220
2 9 8 5 15 -- -- 220
2 10 9 6 19 -- 1 251
2 10 9 6 19 -- 1 251
43/ 62 Bilag 2 Sammendrag af EMEA' s budgetter for 2000 – 2002
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 2 EMEA budget summaries 2000 – 2002
2000( 1)
2000(1)
2001( 2)
2001(2)
2002( 3)
2002(3)
Gebyrer Tilskud over EU' s almindelige budget Særligt EU- bidrag til sjældne
Fees General EU contribution Special EU orphan medicinal
39 13
39 13
154 000 200 000
154 000 200 000
70, 82% 23, 88%
70.82% 23.88%
45 771 000 14 700 000
771 000 700 000
49 14
49 14
000 000 000 000
000 000 000 000
69, 46% 19, 84%
69.46% 19.84%
lægemidler Bidrag fra EØS Bidrag fra EU- programmer
product contribution Contribution from EEA Contribution from EU
000 000 245 220
000 000 245 220
1, 81% 0, 44%
1.81% 0.44%
300 000 310 000
300 000 310 000
4, 68% 0, 44%
4.68% 0.44%
(PERF)
programmes (PERF)
2 314 360
2
632 000
632 000
2 193 000
193 000
287 220
287 220
866 000 100, 00%
866 000 100.00%
547 000
547 000
Udgifter Personaleomkostninger
Expenditure Staff
Lønninger Vikarer og andre hjælpeansatte Andre personalerelaterede udgifter
Salaries Interim and other support persons Other staff-related expenditure Total title 1 Building/ equipment
18 1 1
18 1 1 20
493 000 058 000 350 000
493 000 058 000 350 000 901 000
33, 45% 1, 91% 2, 4%
33.45% 1.91% 2.44% 39.80%
20 1 1
20 1 1 23
615 000 31, 30% 414 000 2, 15% 683 640 2, 56%
615 000 31.30% 414 000 2.15% 683 640 2.56% 712 640 36.00%
24 1 1
24 1 1 28
952 000 905 000 776 000
952 000 905 000 776 000 633 000
35, 37% 2, 70% 2, 52%
35.37% 2.70% 2.52% 40.59%
Husleje/ afgifter Udgifter til databehandling Andre kapitaludgifter Porto og telekommunikation
Rent/ charges Expenditure on data processing Other capital expenditure Postage and communications
212 220 423 500 353 000 480 000
212 220 423 500 353 000 480 000
9, 43% 4, 38% 4, 26% 0, 87%
9.43% 4.38% 4.26% 0.87%
5 4 1
5 4 1
149 000 7, 82% 293 000 6, 52% 658 000 2, 52% 617 000 0, 94%
149 000 7.82% 293 000 6.52% 658 000 2.52% 617 000 0.94%
936 000 570 000 170 000 394 000
936 000 570 000 170 000 394 000
8, 41% 3, 64% 1, 66% 0, 56%
8.41% 3.64% 1.66% 0.56%
Andre administrative udgifter Afsnit 2 i alt Driftsudgifter
Other administrative expenditure Total title 2 Operational expenditure
1 12
1 12
593 000 061 720
593 000 061 720
2, 88% 21, 82%
2.88% 21.82%
1 13
1 13
829 000 2, 78% 546 000 20, 57%
829 000 2.78% 546 000 20.57%
1 11
1 11
925 000 995 000
925 000 995 000
2, 73% 17, 00%
2.73% 17.00%
Møder Vurderinger Oversættelse Undersøgelser og konsulenter Publikationer
Meetings Evaluations Translation Studies and consultants Publications
3 18
3 18
270 000 682 500 p. m.
270 000 682 500 p. m.
5 000 150 000
5 000 150 000
5, 92% 33, 79% 0, 00% 0, 01% 0, 27%
5.92% 33.79% 0.00% 0.01% 0.27%
4 21
4 21
110 000 6, 24% 308 000 32, 35% 428 000 0, 65% 225 000 0, 34% 190 000 0, 29%
110 000 6.24% 308 000 32.35% 428 000 0.65% 225 000 0.34% 190 000 0.29%
4 23
4 23
320 000 333 000 359 000 85 000 190 000
320 000 333 000 359 000 85 000 190 000
6, 12% 33, 07% 0, 51% 0, 12% 0, 27%
6.12% 33.07% 0.51% 0.12% 0.27%
346 360 8, 20%
346 360 8.20%
2,, 1%
2.31%
324 500
324 500
607 360 43, 43%
607 360 43.43%
919 000
919 000
55 287 220
55 287 220
70 547 000
70 547 000
Bemærkninger (1) Endelige bevillinger for 2000.
(1) Final appropriations for the 2000.
(2) Endelige bevillinger for 2001.
(2) Final appropriations for 2001.
(3) Budget for 2002 som vedtaget af bestyrelsen den 18. 12. 2001.
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 3 EMEA guidelines for 2002
44/ 62 Bilag 3 EMEA' s retningslinjer for 2002
 EMEA 2002 Page 44/ 62
Følgende dokumenter forventes afsluttet eller sendt til høring i 2002.
The following documents are intended to be finalised or released for consultation in 2002.
Titel på dokumentet Revision of Note for Guidance on minimising the risks of TSE transmission via medicinal products CPMP recommendations on vCJD and plasma derived medicinal products – CPMP recommendations on transmissible agents and urinary derived medicinal products Note for guidance on the use of bovine serum used in the manufacture of human biological medicinal products Note for guidance on the production and quality control of animal immunoglobins and immunosera for human use Cell culture inactivated influenza vaccines – Annex to Note for guidance on harmonisation of requirements for influenza vaccines EU recommendations for the influenza vaccine composition for the season 2002/ 2003 Plasma master file:
Document title Revision of Note for guidance on minimising the risks of TSE transmission via medicinal products CPMP recommendations on vCJD and plasma derived medicinal products – CPMP recommendations on transmissible agents and urinary derived medicinal products Note for guidance on the use of bovine serum used in the manufacture of human biological medicinal products Note for guidance on the production and quality control of animal immunoglobins and immunosera for human use Cell culture inactivated influenza vaccines – Annex to Note for guidance on harmonisation of requirements for influenza vaccines EU recommendations for the influenza vaccine composition for the season 2002/ 2003 Plasma master file:
Contribution to part S. 2. 3 of the structure of the dossier for applications for marketing authorisation – control of starting materials for the production of plasma- derived medicinal products
Contribution to part S.2.3 of the structure of the dossier for applications for marketing authorisation – control of starting materials for the production of plasma-derived medicinal products
CPMP- arbejdsgruppe vedrørende blodpræparater
CPMP Blood Products Working Party
Titel på dokumentet Note for guidance on the clinical investigation of plasma derived antithrombin products Core summary of product characteristics for plasma- derived antithrombin products Note for guidance on the clinical investigation of human normal immunoglobulin for intramuscular and subcutaneous use Core summary of product characteristics for human normal immunoglobulin for intramuscular and subcutaneous use Note for Guidance on the clinical investigation of plasma derived fibrin sealants Core summary of product characteristics for plasma derived fibrin sealants Note for guidance on the clinical investigation of von Willebrand factor Core summary of product characteristics for von Willebrand factor Note for guidance on the clinical investigation of alpha1 antitrypsin Core summary of product characteristics for alpha1 antitrypsin Core summary of product characteristics for the following specific immunoglobulins:
Document title Note for guidance on the clinical investigation of plasma derived antithrombin products Core summary of product characteristics for plasma-derived antithrombin products Note for guidance on the clinical investigation of human normal immunoglobulin for intramuscular and subcutaneous use Core summary of product characteristics for human normal immunoglobulin for intramuscular and subcutaneous use Note for Guidance on the clinical investigation of plasma derived fibrin sealants Core summary of product characteristics for plasma derived fibrin sealants Note for guidance on the clinical investigation of von Willebrand factor Core summary of product characteristics for von Willebrand factor Note for guidance on the clinical investigation of alpha1 antitrypsin Core summary of product characteristics for alpha1 antitrypsin Core summary of product characteristics for the following specific immunoglobulins:
Human varicella- zoster immunoglobulin i. v.
Human varicella-zoster immunoglobulin i. v.
Human cytomegalovirus immunoglobulin i. v.
Human cytomegalovirus immunoglobulin i. v.
Human rabies immunoglobulin i. m.
Human rabies immunoglobulin i. m.
Human tetanus immunoglobulin i. m.
Human tetanus immunoglobulin i. m.
Human tick- borne encephalitis immunoglobulin i. m.
Human tick-borne encephalitis immunoglobulin i. m.
Human measles immunoglobulin i. m.
Human measles immunoglobulin i. m.
Human rubella immunoglobulin i. m.
Human rubella immunoglobulin i. m.
Core summary of product characteristics for Hepatitis B immunoglobulin Revision of core summary of product characteristics for human normal immunoglobulin for intravenous use – addition of indication for treatment of parvovirus B19 infection Revision of core summary of product characteristics for human plasma derived factor VII products and human plasma prothrombin complex Revision of core summary of product characteristics for factor VIII inhibitor bypassing fraction Warning on transmissible agents for patient leaflets and summary of product characteristics Revision of core summary of product characteristics for human anti- D immunoglobulin for intravenous and/ or intramuscular use (CPMP/ BPWG/ 574/ 99)
Core summary of product characteristics for Hepatitis B immunoglobulin Revision of core summary of product characteristics for human normal immunoglobulin for intravenous use – addition of indication for treatment of parvovirus B19 infection Revision of core summary of product characteristics for human plasma derived factor VII products and human plasma prothrombin complex Revision of core summary of product characteristics for factor VIII inhibitor bypassing fraction Warning on transmissible agents for patient leaflets and summary of product characteristics Revision of core summary of product characteristics for human anti-D immunoglobulin for intravenous and/ or intramuscular use (CPMP/ BPWG/ 574/ 99)
45/ 62 CPMP- arbejdsgruppe vedrørende virkninger
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 CPMP Efficacy Working Party
Titel på dokumentet Note for guidance on clinical investigation of medicinal products for the treatment of diabetes mellitus Note for guidance on clinical investigation of anti- depressive agents Note for guidance on clinical investigation of medicinal products for pain treatment Position paper on new modified formulations of acetyl salicylic acid in the secondary prevention of cardiovascular events Note for guidance on clinical investigation of medicinal products for treatment of peripheral arterial occlusive disease Concept paper on the revision of the Note for guidance on evaluation of new anti- bacterial medicinal product (CPMP/ EWP/ 558/ 95) and the Note for guidance on the pharmacodynamic section of the summary of product characteristics for antibacterial products Points to consider on biostatistical/ methodological issues arising from CPMP discussion on licensing applications:
Note for guidance on clinical investigation of medicinal products for treatment of peripheral arterial occlusive disease Concept paper on the revision of the Note for guidance on evaluation of new anti-bacterial medicinal product (CPMP/ EWP/ 558/ 95) and the Note for guidance on the pharmacodynamic section of the summary of product characteristics for antibacterial products Points to consider on biostatistical/ methodological issues arising from CPMP discussion on licensing applications:
Adjustment for multiplicity and related topics Points to consider on biostatistical/ methodological issues arising from CPMP discussion on licensing applications:
Adjustment for multiplicity and related topics Points to consider on biostatistical/ methodological issues arising from CPMP discussion on licensing applications: