natgillin/translations-raw huggingface dataset:
EMEA/ MB/ 003/ 01- EL - ςετνογάραπ
24 EMEA Work Programme 2001-2002
νητσ
3.9 Availability of medicines
νώλυοβ υσ ήχοραΠ CVMP
• Immunologicals Working Party
ςετνογάραπ ςύοκαιβορκι ιτνα ςυοτσ ήχονα νητσ νωτνόϊορπ νώκιτυεκα ραφ νώκιρταινητκ νωτ νωεσώτπιπε νωνε όχεδνε νωτ ηση ίτκε νητ οχότσ ε ςαιεδά ςησηγήροχ ςητ ιατνύογηορπ υοπ ςετέλε ςετνογάραπ ςύοκαιβορκι ιτνα ςυοτσ ήχονα
Following the publication of the Commission Communication to the Council and the European Parliament on availability of veterinary medicines (COM(2000) 806 final, 5.12.2000), the CVMP and EMEA secretariat will continue to support all initiatives and proposals being considered to facilitate the availability of veterinary medicines to minor species.
ςιτ ε άκιτεχσ α ην όπυ όκιτηγηδοθαΚ νητ αιγ ςαίσαγρε αδά ο ήκιδιΕ αλάγ οτσ ιατνοζάισυοραπ υοπ νωτνόϊορπ.
– Development of guidelines and position papers: • Harmonisation of requirements for low (efficacy) and high (safety) potency and batch consistency of vaccines • Gene therapy • Vectored vaccines (when the vector is part of the vaccine) • Revision of CVMP guidance with regard to compliance with the European Pharmacopoeia • Review of equine influenza guidelines
-
3.10 Working parties and ad hoc groups • Efficacy Working Party
νώκιτυεκα ραφ νώκιρταινητκ νωπίολατακ άιδιαπ ατ όπα ηψηλσόρπ αιγ υονύδνικ υοτ ηση ίτκΕ ςησυελλάτε κε ςίεροφ ςυοτ αιγ ςαίελαφσα ςέ αργ ςειρήτνυθυετακ αιγ ςηκγάνα ςητ ηση ίτκΕ άγβα ατ αιγ ςησρυσόπα νωδόιρεπ νωτ ό σιροθακ νοτ ε άκιτεχσ α ην όπυ όκιτηγηδοθαΚ
• Note for guidance on DNA vaccines combined with cytokines and cytokines used for therapeutic purposes • Immunological veterinary medicinal products used for
- - -
– Revision of existing guidelines:
MRL
treatment in accordance with Article 1(3) of Council
νωτ ό σιροθακ νοτσ ςυοδόθε ςέκιτυλανα ςενέ ηιοποπυτ αιγ ςησητίαπα ςητ ησηίοποκιτσιρΟ ςησωρέιθακ ςητ ιεψό νε αδίρωλχ ήκιρετνε MRL,
• Ectoparasiticide guideline for sheep, cattle and goats
-
Directive 90/677/EEC
ηνιπώρθνα νητσ ςησυελέορπ ςήκιωζ α ιφόρτ όπα νωτνόγαραπ νώκαιβορκι ιτνα απιολάτακ ατ νυοχέ υοπ νωεσώτπιπε νωτ ςαίελαφσα ησηγόλοιξα νητ αιγ ςή αργ VICH νητ όπα ςαίελαφσα ςή αργ ςαιρήτνυθυετακ υοίδεχσ υοτ
•
ςαιρήτνυθυετακ ςητ ησηρώεθανΑ ςητ ςοτα όνο ξε ησηπόκσιπΕ CVMP αιελάφσα νητ αιγ ςαίσαγρε αδά Ο
Antimicrobials for general veterinary use
- -
•
νωίρητσαγρε ησωνάγρο νητ ε
Guidance on the evaluation of fluid therapy in case of diarrhoea
υοτ ςετητόιρητσαρδ ςιτσ ήχοτε υΣ PERF II
• Pharmacovigilance Working Party – Finalisation of the Veterinary Medicinal Dictionary for Drug
-
– Development of new guidelines: • Biostatistical guideline
αι ιατεχέραπ αν ετσώ νωκά ραφ ςησηθύολοκαραπ ςοτα άργορπ
Regulatory Authorities (VEDDRA) list of clinical terms
ςόνε ησηίοποτσιτλεβ ωρέτιαρεΠ ςήπορτιπΕ)
– Finalise and implement the electronic transmission and
ςητ Κ 2000/ 37/ Eαίγηδο νητ όπα υοίλυοβ υΣ υοτ ΚΟ
Guideline for the conduct of efficacy studies for non- steroidal anti-inflammatory drugs
ςαίγηδο ςητ ησηίοποπορτ αίσεθο ον 81/ 851/ E (
management of pharmacovigilance information and data following implementation of EudraVigilance
ιακ νώιροφορηλπ ςησιρίεχαιδ ιακ ςησαβίβαιδ ςήκινορτκελη ςητ ησηίοπολυ ιακ ησηίοποκιτσιρΟ νωτνόϊορπ νώκιτυεκα ραφ (VEDDRA)
– Development of position papers and policy papers – Revise current guidelines in the light of changes of the
ςέχρα ςέκιτσι θυρ ςιτ αιγ ύοκιξελ ύοκιρταινητκ υοίλυοβ υΣ υοτ ΚΟ
Advice to the CVMP regarding the risk management strategic plan on antimicrobial resistance to include:
υοτ νωρό νώκινιλκ υογόλατακ υοτ ησηίοποκιτσιρΟ ησηνπύργαπεοκα ραφ ητ αιγ ςαίσαγρε αδά Ο
relevant legislation (amendment of Council Directive 81/851/EEC by Commission Directive 2000/37/EC)
ςαίγηδο ςητ ςοφαργάραπ ορθρά οτ 90/ 677/ E 3 1
Pharmacodynamic/pharmacokinetic modelling of
DNA νωππί νωτ ηπίργ ητ ε άκιτεχσ νώ αργ νωιρήτνυθυετακ νωτ ησηπόκσιπΕ αίιοποκα ραΦ ήκϊαπωρυΕ νητ ε ησωφρό υσ ητ ε άκιτεχσ ςητ ςή αργ ςαιρήτνυθυετακ ςητ ησηρώεθανΑ
– Further optimisation of a drug monitor scheme in order to antimicrobials provide a summary of all key and relevant pharmacovigilance
CVMP υοίλοβ ε υοτ ςορέ ίελετοπα ςαέροφ ο υοπό αέροφ ε αιλόβ Ε
Standard phrases for product literature for antimicrobials
) (αίεπαρεθ ήκαιδινοΓ νωίλοβ ε νωδίτραπ νωτ ατητόιοπ νητσ ατητόρεθατσ
information, enhance traceability of issues under
ιακ ςαιελάφσα ςήληψυ ιακ ςατητόκιτα σελετοπα ςήλη αχ ύχσι αιγ νωεσήτιαπα νωτ ησινό ρανΕ νωεσέθ νωφάργγε ιακ νώ αργ νωιρήτνυθυετακ ησιτράταΚ
Guidelines for antimicrobial prophylaxis, combination therapies, in-feed and water mass medication
: ατνόϊορπ άκιτυεκα ραφ άκιγολοσονα ατ αιγ ςαίσαγρε αδά Ο ςαίλυοβοτωρπ ςητ οισίαλπ οτσ ιατεπέλβορπ ςωπό ςερώχ
investigation, and to provide a general overview on post- marketing surveillance studies
PERF II. ηξατνέ αιγ ςειφήψοπυ ςιτ όπα ΕΕ ςητ ςότκε ςέχρα ςέκιτσι θυρ ε ςιεσήτνανυσ ςέκιτωρε ηνε ού∆ ςετητόιρητσαρδ ςελλΆ
Minor indications and minor species guidance document
·
• •
:
Standard phrases for summary of product characteristics Glossary of terms for therapeutic claims
-
– Participation in PERF II activities through workshops
38/ 65
– Other tasks:
αδίλεΣ
•
όκιλεΤ
Two informative meetings with non-EU regulatory authorities from the enlargement countries as foreseen within the PERF II initiative
ςαίσαγρε α αργόρΠ 2001- 2002
EMEA Work Programme 2001- 2002
.
25
νητ όπα ιατά ιτκε ιακ ιατεζίρωνγανα ορδεόρπ νοτ ςορπ ΑΕΜΕ υοτ ςαίετα αργ ςητ ηξιρήτσοπυ η ιακ ςενή ιξέ εθάκ ΕΕ ςητ αίρδεορπ νητ ε ανωφ ύσ ιατεσσάλλανε ςαδά ο ςητ αίρδεορπ Η νητσ ησαβίβαιδ αιγ ιακ
• Safety Working Party – Review on behalf of CVMP draft safety guideline from VICH
CVMP.
3.11
νώχρα (HEVRA)
Veterinary mutual recognition facilitation group
νώκιτσι θυρ νώκιρταινητκ νωτ νωνέ ατσϊορπ νωτ ησέθοτσι νητσ ησυείσο ηδ αιγ ιατνοζίροορπ υοπ νωφάργγε νωτ ηξατνύσ ητσ ςησίπε ιε άρδνυσ αίετα αργ Η ατα ήτηζ άκιτσακιδαιδ. αιγ ςετνύοτια ςυοτσ νώλυοβ υσ ήχοραπ νητ ιακ ςώθακ ηρέ ανε όρεφαιδνε ατ ε νωεσάιρδενυσ
– Revise guideline on safety evaluation of effects of
νωτ ό σινοτνυσ νοτ νυονάβ αλιρεπ ςηξιρήτσοπυ ςετητόιρητσαρδ ςελλά υοπύτ νωίτλεδ
Useful web site: antimicrobial residues in food from food animals on human gut flora for the establishment of MRLs – Finalise requirement for routine analytical methods in establishment of MRLs
,
Heads of agencies for medicines for veterinary use http://www.hevra.org
νωτ ιακ νωεσάφοπα νωκάνιπ νωτ ςηξατάιδ ςαισήρε η ςητ ςαίσα ιοτεορπ ςητ ςηνέ οναβ αλιρεπ υσ, ςησηθύολοκαραπ νωτήτοιρητσαρδ νωτ ιακ νωεσάιρδενυσ νωτ αίσα ιοτεορπ ήκιδοξειδ ητ όπα ςότκΕ, ΕΕ ςητ ηλέ ητάρκ ατ αλό όπα νώχρα νώκιτσι θυρ νωτ ςυοχύοτα ωιξα ςύοκιτνα ησ όπα. ιατεζίτραπα ιακ ςαίσακιδαιδ ςηνέ ωρτνεκοπα ςητ ό σινοτνυσ οτ οχότσ ε ησάβ αίαινη εσ ΑΕΜΕ
The Unit will continue to provide full secretariat support to the – Guidance note on determination of withdrawal Veterinary Mutual Recognition Facilitation Group (VMRFG) periods in eggs which meets at the EMEA on a monthly basis to coordinate the – Consider need for operator safety guidelines – Assessment of risk in relation to intake of residues from veterinary medicinal products in milk for children
υοτ ςιεσάτσατακγε ςιτσ ιεζάιρδενυσ αίοπο η
decentralised procedure and which is made up of key regulatory officials from all EU Member States.
(VMRFG) ςησιρώνγανα ςαίαβιο α ςητ ησνυλόκυειδ
In addition to extensive preparation of meetings and follow-up activities, including preparation of agenda, tables of decision
ητ αιγ αδά ο ήκιρταινητκ νητσ ηξιρήτσοπυ ήκαιετα αργ ηρήλπ ιεχέραπ αν ιεσίχενυσ αθ αδάνο Η
• ad hoc Group on Antimicrobial Resistance – Note for guidance on pre-authorisation studies to assess the potential impact of veterinary medicinal products to antimicrobial resistance
http: // www. hevra. org
and press releases, other support activities include coordination of meetings with interested parties as well as giving advice to applicants on procedural issues.
ατνόϊορπ άκιτυεκα ραφ άκιρταινητκ ατ αιγ ίο σιναγρο ιοιδό ρΑ: ησνυθύειδ ήκινορτκελη η ισήρΧ ςησι ρώ ν γανα
The Secretariat also provides assistance in the compilation of documents for publication on the web site of the Heads of
α ςη τ ησνυλόκυειδ ητ αιγ αδά
– Providing advice to the CVMP on specific issues relating to antimicrobial resistance
ο ή κιρταινητΚ
Veterinary Regulatory Agencies (HEVRA) and for transmission to the CVMP.
όκιλεΤ
26 EMEA Work Programme 2001-2002
3. 11
The chair of the group rotates every six months with the EU presidency and the support to the chairman by the EMEA secretariat is acknowledged and appreciated by the Group.
ςαίσαγρε α αργόρΠ 2001- 2002
Chapter 4 Inspections • Work on 5 mutual recognition agreements (MRA) will
EMEA/ MB/ 003/ 01- EL -
The Sector for inspections is part of the Technical Coordination Unit
οτ ιακ
continue with Switzerland, Canada, New Zealand, Australia and Japan
οτ
Head of Sector Stephen FAIRCHILD (until 15th April 2001)
όπα νύοθηξυα αν ιατενέ ανα νωτνόϊορπ νώκιτυεκα ραφ ησιρκγέ αιγ ςιεσήτια ιΟ 8. 357 ςησηίοπολυ ό θαβ οτ αιγ ατητόιαβεβα νητ άραπ ΑΠΗ ςιτ ε ςησιρώνγανα,
Resource allocation is made for work on the MRA with the USA, despite uncertainties about the rate of implementation
ςαίαβιο α ςαίνωφ υσ ηψανύσ η ιεσήτιαπα αθ υοπ ςείσαγρε ςιτ αιγ νωρόπ ησεθάιδ ιατεπέλβορΠ αίνωπαΙ νητ ιακ αίλαρτσυΑ ςητ αίδναληΖ αέΝ ητ άδαναΚ νοτ
Joint CPMP/CVMP Quality Working Party Jean-Louis ROBERT
,
•
ςησιρώνγανα ςαίαβιο (MRA) ςιεσήρωεθιπΕ ςιεσήρωεθιπΕ ςιεσήρωεθιπΕ
Requests for certificates of medicinal products are expected to increase from 8 357 in 2000 to 10 000 in 2001 and in 2002
α ςείνωφ υσ ςιτ αιγ ςείσαγρε ιο νύοτσιχενυσ αΘ 5 2002 2001 2000 0 GLP 10 20 GCP 30 40 GMP 50 60 70
Operational procedures will be reviewed to improve the level of Cerificates of a medicinal product 2000-2002 service provided, in particular focusing on activities related to the Joint CPMP/CVMP Quality Working Party and the ad hoc
νύοθηξυα αν ςησίπε ιατενέ ανα
Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) Inspectors’ Groups.
2000- 2002
10000
ςήκιτκαρπ ςήκαιρητσαγρε ςήθρο ςησηρώεθιπε ατα ήτια
• Increase in GMP inspections performed from 63 in 2000 to 67 in 2001 and 70 in 2002, reflecting the increase in applications for initial authorisation and variations in the centralised procedure, and also relating to orphan medicinal
αΤ
5000
ιακ
products
12
• Increase in GCP inspections performed from 4 in 2000 to 8 in 2001 and 12 in 2002.
οτ εσ
2000
8 2001
2001
2002,
2002
εσ ιακ 70
In 70
οτ
60 50 40 30
2001εσ
Preparation will also be made for EMEA joint management, with the Commission and national competent authorities, of databases for the exchange of information on
67οτ
20
όπα
10
ROBERT ιρχέ 2001)
2001
EMEA/ MB/ 003/ 01- EL - νώιεγρενε νωτη ύθιπενα νώραβοσ ςέροφανα ιακ ςέ ικοδ ςέκινιλκ ε άκιτεχσ. νώιροφορηλπ ήγαλλατνα νητ αιγ νωνέ οδεδ νωεσάβ νωτ ςέχρα ςειδό ρα ςέκινθε ςιτ ιακ ήπορτιπΕ, ήκϊαπωρυΕ νητ ΑΕΜΕ νοτ όπα ησιρίεχαιδ ήνιοκ αιγ αίσα ιοτεορπ ςησίπε ιεξράπυ αΘ νώιεγρενε
EMEA Work Programme 2001-2002
,
27
.
Chapter 5 Administration and support activities
νωτη ύθιπενα νώραβοσ ςέροφανα ςιτ ιακ
Administration Unit Head of Unit Andreas POTT
ιακGMP
Technical Coordination Unit Head of Unit Karel de NEEF (until 14th March 2001)
ςιεσήρωεθιπε ςιτ ε ησέχσ εσ αίγηδο GCP
Head of Sector for personnel, budget and facilities Frances NUTTALL
υοπ ογρέ οτ ε ό σαυδνυσ εσ
Head of Sector for inspections Stephen FAIRCHILD (until 15th April 2001)
νώτηρωεθιπε ςεδά ο ςέκιδιε ςιτ ε ςωίρυκ αίγηδο νητσ
Head of Sector for accounting Gerard O’MALLEY
ιατεζίρο ςωπό ςησηγήδοθακ νωφάργγε ςάριεσ ςαι ηξατνύσ ητσ νύοθωρτνεκιπε αθ νώισαγρε αιδέχσ
Head of Sector for document management and publishing Beatrice FAYL
άκιχρα αΤ
Head of Sector for conference services Sylvie BÉNÉFICE
υοτ ςότνε νυονίγ αθ
5.1 Administration The Administration Unit staff level reflects the demand-driven
2001
2001 to put in place reserve lists for suitably qualified staff to cover needs up to the end of 2002.
θρα ςαίγηδο ςητ ήγο ραφε νητ αιγ ςείσα ιοτεορπ ιΟ
workload of the Agency in 2001-2002 and the operational activities arising from the growth in the units for human and veterinary medicines, the expanded office space and associated facilities.
2000
A computerised personnel system with an intranet function was selected in 2000 and will be implemented in 2001-2002.
νώκιρδεφε ησιτράτακ νητ αιγ ςήγολιπε ςείσακιδαιδ ώτκο νύοθηιοποτα γαρπ αθ οτ αιγ εσ ιακ
The staff training programme will be reinforced in 2001-2002 and a strategy for professional training will be developed with
2001
The principal objectives of the Administration Unit remain unchanged for the years 2001 and 2002, and include • sound management of human, budgetary and technical resources
ύοκιπωσορπ ςοτνύορωχοπα ιακ υοέν ςοτνοχράπυ υοτ νώχοραπ νωτ ςησιρίεχαιδ ςύοκραιδ ςητ
the aim to set up a comprehensive and coherent scheme assuring both a continuous adaptation to a changing work environment and the improvement of professional competencies.
ιακ ςώθακ ιατίετιαραπ υοπ ύοκιπωσορπ υοτ ςησατσάτακιτνα ςητ ιακ ύοκιπωσορπ υοέν ςηψηλσόρπ ιακ ςήγολιπε ςητ ωγόλ ςαίσαγρε οτρόφ όκιτνα ησ ε ιατενύραβ αν ιεσήθυολοκαξε αθ όκιπωσορπ οΤ
• further development of efficient management and organisational structures • adaptation of administrative structures and procedures to a growing Agency as well as to new developments in the area of human resource management and information and office technologies An improved budget planning process will be developed in 2001 to make a closer link between budget activities and the work planning process.
ςιεσάτσατακγε ιακ ςό σιγολοπϋορπ όκιπωσορΠ
The facilities work programme covers a wide range of activities necessary for the effective and efficient functioning of the Agency.
. νώισαγρε ύο σαιδεχσ ςαίσακιδαιδ ςητ ιακ νωτήτοιρητσαρδ νώκι ονοισο ηδ νωτ ησεδνύσ ηρετόνετσ
Accounting Key objectives in 2001-2002 include:
ητ οχότσ ε ύο σαιδεχσ ύοκι ονοισο ηδ αίσακιδαιδ ηνέ ωιτλεβ αι ίεθχυτπανα αθ
Pers onnel, budget and facilities Personnel will continue to experience an important workload due to selection and the recruitment of new staff and the replacement of staff who resign as well as the continuing administration of entitlements for existing, new and leaving staff.
2001
The number of posts requested by the Agency is 220 in 2001 and 251 for 2002.
ιακ ητέ ατ αιγ ιοτηλβάτε α νυονέ αραπ ςησηκίοιδ ςαδάνο ςητ ιοχότσ ιοιρύκ ιΟ 2001
Eight selection procedures will take place in 28 EMEA Work Programme 2001-2002
ιακ ηνιπώρθνα αιγ ατνόϊορπ άκιτυεκα ραφ ατ αιγ νωδάνο νωτ ηξυτπάνα νητ όπα νυοέρροπα υοπ ςετητόιρητσαρδ ςέκαισηριεχιπε ςιτ ιακ ησητήζ ητ όπα ιατεζίροθακ ςωπό
• Absorb the increasing level of operations due to the increased activity levels of the operational units, particularly in the areas of meetings and revenue transactions • Further develop analytical and activity costing information as part of the costing exercise • Further develop internal management information mechanisms
οδοίρεπ νητ άτακ 2001- 2002,
Evolution of the EMEA budget 1995-2002
5. 1
70
42/ 65
50
όκιλεΤ
40 Millions 30
,
20
2002
10
οτ αιγ ύο σιγολοπϋορπ οιδέχσορΠ EE άροφσιενυΣ 0 10 20 30 40 50 60 70
0
1995 -
1995
EMEA
1996
2001
1997
,,,
1998
οΤ
1999
ςωέ
2002*
οτ ιτό ά ιτκε
EU contribution
ΑΕΜΕ 2001
Free revenue
οΤ ησήρχ
Miscellaneous
2002
* Preliminary draft budget for 2002 adopted by the Management Board 21-22 February 2001.
νωισό ηδ νώκϊαπωρυε ηξατνύσ ητ ιακ νώλυοβ υσ νώκινο ητσιπε ήχοραπ νητ ε ιατνοζίτεχσ υοπ ςετητόιρητσαρδ ςιτσ
Progress the electronic transfer of data between accounting systems and explore and implement electronic commerce data exchange with third parties, such as suppliers and customers, thereby gaining in productivity
ησιρώχατακ ήκιρτνεκ νητ ήτανυδ ςατνώτσιθακ νωφάργγε νωνε όχρεξε ιακ νωνε όχρεσιε
The project plans to develop a prototype information system linked to an underlying database and then to test the electronic exchange of information between applicants and the EMEA, consolidating this approach over time to include
νωτ ό σιριεχ οτ ιεσώιτλεβ αν ςησίπε ιατενέ ανα νωφάργγε ςησιρίεχαιδ α ητσύσ όκινορτκελη
Develop trained accounting personnel who provide efficient and friendly service to delegates, national competent authorities, customers, suppliers, banks, staff and other EMEA partners
οΤ
•
α ητσάιδ οτσ νωφάργγε ςησιρίεχαιδ ςοτα ήτσυσ ύοκινορτκελη ήγο ραφΕ
the whole process for product information.
2001- 2002. ατνόϊορπ ε ησέχσ εσ ςείροφορηλπ ςιτ αιγ ςαίσακιδαιδ ςητ ολονύσ.
Implement an electronic document management system over 2001-2002.
ςησηίοποπορτ ςιεσήτια ιακ οσό ςιεσήτια ςιερήλπ οσότ νύοροφα αθ αίοπο ατ ατνόϊορπ ε άκιτεχσ,
The electronic document handling system should also improve the handling of incoming and outgoing documents, in particular allowing central registration, storage and access.
2001
The system will first be implemented in 2001 in
:
These activities include quality management (particularly in the areas of translations, product information quality and the coherence of regulatory documents) and logistics (the EMEA library, physical and electronic archiving, and internal mail services)
2001- 2002
It will be extended in 2002 to the activities of the CPMP and its working parties.
νωφάργγε ησυείσο ηδ ιακ ησιρίεχαι∆
The EMEA expects to receive between 10 000 and 12 000 pieces of mail a year in 2001 and 2002 and send out about 20 000 pieces of mail.
αιγ νωδά ο νωτ ιακ ςαίσαγρε νωδά ο νωτ
• Increase in documents handled by the sector for publication
οΤ 2001
Priorities in 2001-2002 are: • Continue the product information management project (PIM) in 2001 with a view to reducing workload for industry and regulators for the maintenance of product information
οΤ 2001
on EMEA web site in 2001 and 2002.
οφορό ο νοτσ νωεσάιρδενυσ ιακ νωεψέκσαιδ νώσυοθια νωέν νωτ 3 ησωτάρεπ νητ ε
This is expected to coincide with a only a small increase in number of subscriptions to the EMEA documentation service as more users obtain documents directly from the web site
2001,
documents.
EMEA
PIM is a joint EMEA-EFPIA initiative.
υοτ νωεσάιρδενυσ ςιεσνύλοκυειδ ιΟ ςησηκίοιδ ιακ ςαν ιρέ.
On a trial basis, the EMEA will accept more electronic submissions of product information relating to both full applications and variations using the PIM approach in parallel to assess the feasibility of electronic submissions in this area.
ςήκιτηκιοιδ ατα έθ εσ ςυοπώσορπιτνα ςυοτ αληλλάραπ ςατνο άρδνυσ ιακ ςυορόπ ςετνοχράπυ ςυοτ ςώκραιδ ςατνονώιτλεβ ςείσερηπυ ιακ ςιεσνύλοκυειδ ςέτανυδ ςερετύλακ ςιτ ςατνοχέραπ ΑΕΜΕ υοτ, ςιεσάιρδενυσ ςιτσ ςηξιρήτσοπυ ςήκιτα σελετοπα ησιλάφσαξε νητ αιγ ςονυθύεπυ ιανίε ςότυα ςαέ οτ Ο
• New publication strategy to ensure faster publication of key documents, including local printing of key documents such as annual reports and work programmes • The off-site archiving strategy will be reviewed and a call for tender issued in 2001 EMEA Work Programme 2001-2002 29
όκιλεΤ
5.3 Conference services
ςαίσαγρε α αργόρΠ 2001- 2002
In addition, the following priorities will be progressed.
EMEA/ MB/ 003/ 01- EL - υοτ αιεκράιδ ητσ ίεθωρηλκολο αθ ςαίεγΥ ησωνάγρΟ αι σόκγαΠ 2001.
The Sector is responsible for ensuring efficient support for EMEA meetings by providing the best possible facilities and
νητ ιακ ΑΕΜΕ νοτ όπα
Topic Activities
οτ νύοθατκεπε αθ ςηψεκσάιδελητ ςείσερηπυ ςειζέπαρτιπε ιΟ 2001 ήπορτιπΕ ήκϊαπωρυΕ νητ όπα αέ οτ όκιτυεκα ραφ.
services and constantly improving the resources available, as well as assisting delegates with logistics and administratively. • EMEA meeting facilities will substantially improve in 2001, with the completion of the new conference and meeting rooms on the third floor • Increase in workload of 17% in 2001 is expected, particularly due to more meetings relating to human medicines and PERF activities • A computerised meetings management system will be
νοτσ νώιροφορηλπ νωτ ςαίγολονχετ ςητ ςήκιγηταρτσ ςητ ησατέξεναπε νητ άτακ
IT infrastructure High availability server installation, operating system change, open source software initiative, videoconference phase 3, upgrade of internet security Core application ActiTrak, SI2, SIAMED, development EudraVigilance, personnel management, meetings administration
υοτ
implemented in 2001.
2001
Procedures will also be reviewed to assist with the expected 32% increase in 2001 in delegate reimbursement transactions
αίγολονχετ νητ ε ιατνοέδνυσ υοπ ςετητόιρητσαρδ ςιτ ιεσήξυα αν ιεπέρπ υούτκιδαι∆ υοτ
Network EudraNet, intranet, internet secure environment document transmission, firewall, automatic catalogue
EMEA
•
υοτ ωσέ ηλέ ητάρκ ατσ ςυορίατε ςυοτ ε ιακ ςώθακ οδεπίπε όκιρετωσε εσ
Seek to increase the use of electronic versions of documents circulated to members of committees and working parties.
ςησιρίεχαιδ ιακ ύο σινοτνυσ ςέπορτιπε ςιτσ ςωρήλπ ιεχέτε υσ αθ
This should reduce the volumes of documents photocopied and also the number of documents
ο οδεπίπε όκιγηταρτσ εΣ
General application development
EMEA
Databases for European experts, scientific advice, scientific memory, orphan drugs, etc
ςετητόιρητσαρδ ιακ ςείλυοβοτωρπ ςέκϊαπωρυΕ νώγο ραφε ηξιρήτσοπυ ςηξιρήτσοπυ οίεφαργ,
Additional IT facilities Several upgrades, new transported by delegates to and from meetings devices and technology • Videoconferencing capacities will be developed in 2001-
υούτκιδ ιακ νωτά ητσυσ ηξιρήτσοπυ ιακ ησιρίεχαι∆
2002 in order to improve and maximise the participation by experts in the work of the scientific committees, working parties and mutual recognition facilitation groups
ατνοκήθακ άκιγρυοτιεΛ
Operational tasks
νώιροφορηλπ νωτ ςαίγολονχετ αίγολονχετ ιακ ςέυεκσυσ ςεέν ςιεσί θαβανα ςεροφάι∆
Systems and network administration and support, Helpdesk, application support
πλκ ακα ράφ άναφρο η.,
5.4 Information technology
ςιεσάτσατακγε ςετεθσόρΠ
European initiatives and activities
ήκινο ητσιπε νώλυοβ υσ νώκινο ητσιπε ήχοραπ,
The sector’s mission is to provide reliable and robust IT
, ςενο ώνγοριεπ ε ςυοίαπωρυε αιγ νωνέ οδεδ ςιεσάΒ ιογολάτακ ιοτα ότυα άναγετσ υούτκιδαι∆ υοτ ωσέ,,
At a strategic level the EMEA will participate fully in the Telematics
νώγο ραφε νώκινεγ ηξυτπάνΑ
services to EMEA staff and delegates, together with
·
Steering and Management Committees to coordinate activities
νωνέ οδεδ ησοδάτε ςήλαφσα ουτκίδοδνε
appropriate levels of operational support while introducing new
νολλάβιρεπ όκαυτκι∆
between the EMEA, national competent authorities and the
νωεσάιρδενυσ ησιρίεχαιδ ύοκιπωσορπ,
services and improvements to the infrastructure as required
ησηκίοιδ
European Commission.
ActiTrak, SI2, SIAMED, EudraVigilance,
The Agency’s network will provide secure
νώγο ραφε νώκισαβ ηξυτπάνΑ
from the business and the users. • Ensure a minimum system availability of 98% of IT services
·
communications internally as well as with Member State partners via EudraNet and universally via the internet.
ςαιελάφσα ςήκαυτκιδαιδ ησι θάβανα ςησάφ ηψεκσάιδελητ ςήγηπ ςήτκιονα ύοκι σιγολ
during EMEA working hours • Ensure successful installation and implementation of the EudraVigilance electronic data reporting system for adverse reactions in the human and veterinary sectors
3,
The question of whether EMEA should increase IT activities in the European marketing authorisation system will be addressed in 2001 in the context of the European Commission pharmaceutical IT strategy review.
αίλυοβοτωρπ ςοτα ήτσυσ ύοκιγρυοτιελ ήγαλλα
• Provide support to the installation of a document management system at EMEA
,
Desktop videoconferencing services will be extended in 2001 to facilitate conferences between the EMEA, European Commission and national competent authorities.
νώιροφορηλπ
30 EMEA Work Programme 2001-2002
ςατητό ισεθαιδ ςήληψυ ήτσι οκαιδ ησατσάτακγΕ
EMEA establishment plan 1999 – 2002
ςετητόιρητσαρ∆
EMEA budget summaries 2000 – 2002
·
3.
νωτ ςαίγολονχετ ή οδοπΥ
EMEA contact points and reference documents
α έΘ
4.
·
EMEA Work Programme 2001-2002
:
31
νώκιτυεκα ραφ ςειεγρένε ςετη ύθιπενα ςιτ ε άκιτεχσ
Annex 1 EMEA establishment plan 1999 – 2002
νωνέ οδεδ ςάροφανα EudraVigilance
Category and Grade
υοτ ςηξάτ ςητ νώιροφορηλπ 98%
Occupied as per Occupied as per 31.12.1999 31.12.2000
αδίλεΣ
Authorised for 2001
ιροφορηλπ αίγολο νχεΤ ςαίσαγρε α αργόρΠ 2001- 2002
Requested for 2002
5. 4
A1
EMEA
-- --
υοτ νώχελετσ νώκισαβ νωτ ατα ώιε ησ άκιφαργοιβ α οτνύΣ ΑΕΜΕ υοτ ςάροφανα αφαργγέ ιακ ΑΕΜΕ νοτ ε αίνωνιοκιπΕ
--
3.
--
2000 –
A2
αΠ α
--
ΟΛΟΝΥΣ B1 B2 B3 B4 B5
Total A
A
Total A
90 1 3 6 5 4
1
98 3 4 6 5 5
3
111 4 8 9 6 5
4 5 5
122 4 9 11 9 8
8