natgillin/translations-raw huggingface dataset:
New issues to be faced in 2003 with workload implications:
Anskaffa bättre externa arkivresurser för det ökande antalet akter som hålls av EMEA, tillsammans med förbättrade system för dokumenthantering.
• Revision of EMEA financial regulation and implementing rules
EMEA arbetsprogram för 2003 EMEA/ MB/ 057/ 02/ sv/ Slutlig 6. 3 Redovisning
Number of payments received and made
In - och utbetalningar
following reform of the EU financial regulation
14393 2003 1642
20000 • Implementation of improved systems to facilitate reimbursement of meeting expenses and follow-up of fee payment issues with applicants and marketing authorisation 15000 holders 14393 • Upgrading of the SI2 accounting system 12955 10000 5000
12955 2002 1752
1642
Antal inbetalningar
system
Antal utbetalningar
2001
Den samlade arbetsbördan för redovisningssektorn väntas öka med 21 procent under 2003 jämfört med 2001 års nivåer.
I Payments received I Payments made
Uppgradering av redovisningssystemet SI2.
• Overall workload for the Accounting Sector is expected to grow by 21% in 2003 over 2001 levels
Fortlöpande uppgradering av ActiTrak- systemet och förbättring av kostnadsplaner för verksamheten (inklusive utgifter i samband med rapportörer).
• Productivity gains achieved will not be sufficient to offset further increases
Deltagande i utvecklingen av en översyn av EMEA: s avgiftssystem.
• Trends in the number of centralised applications will have only limited impact on workload of the Sector
EMEA arbetsprogram för 2003 EMEA/ MB/ 057/ 02/ sv/ Slutlig Bilagor
• Increased number of delegates and meetings in 2003 will result in increased number of transactions to be executed 30 EMEA Work Programme 2003
Sida 37/ 58
Chapter 1 Annexes EMEA in the European system 1.
1.
EMEA establishment plan 2001– 2003
Tjänsteförteckning för EMEA 2001- 2003
EMEA guidance documents in 2003
Budgetsammanfattningar för EMEA 2001- 2003
EMEA Work Programme 2003
EMEA: s riktlinjedokument 2003
Annex 1 Chapter 1 EMEA in the European system – 2003 establishment plan 2001
EMEA arbetsprogram för 2003 EMEA/ MB/ 057/ 02/ sv/ Slutlig Bilaga 1 Tjänsteförteckning för EMEA 2001- 2003
Category and Grade
Godkända Besatta
Occupied as at 31.12.2001
tjänster för 2002 31. 12. 2001)
Authorised for Occupied as at 2002 31.12.2002
31. 12. 2001) tjänster för 2002 31. 12. 2001)
Authorised for 2003
tjänster för 2003
1 1
-- -- 1 1 5 5
A8
DELSUMMA A B1 B2 B3 B4 B5 DELSUMMA B C1 C2 C3 C4 C5 DELSUMMA C D1 D2 D3 D4 DELSUMMA D
3 2 EMEA Work Programme 2003
2002( 2)
(Amounts expressed in euro)
2003( 3)
(31.12.2002)
Inkomster
(19.12.2002)
Avgifter EU: s allmänna bidrag EU: s IT- strategibidrag
69.49% 22.32% --
69, 49% 22, 32% --
63.58% 27.95% --
63, 58% 27, 95% --
61.66% 19.85% 8.97%
61, 66% 19, 85% 8, 97%
products Contribution from EEA Contribution from EU programmes (PERF) Other
EU: s särläkemedelsbidrag Bidrag från EES
0.91% 0.44% 3.51% 3.33%
0, 91% 0, 44%
4.49% 0.60% 0.38% 3.00%
4, 49% 0, 60%
4.23% 0.71% 1.83% 2.75%
Bidrag från EU- program (PERF)
78 081 000
78
100.00%
081 000 100, 00%
Expenditure Staff
Utgifter Personal
Salaries Interim and o ther support persons Other staff-related expenditure
Löner Extern personal och andra stödpersoner
31.30% 2.15% 2.56%
31, 30% 2, 15%
24 850 000 1 760 000 1 502 000
850 000 760 000
40.54% 2.87% 2.45%
40, 54% 2, 87%
29 130 000 1 845 000 2 213 000
29 1
37.31% 2.36% 2.83%
130 000 37, 31% 845 000 2, 36%
Total title 1
Övriga personalkostnader Summa avdelning 1 Byggnader och utrustning
36.00%
2, 56% 36, 00%
28 112 000
1 28
45.86%
502 000 112 000
33 188 000
2, 45% 45, 86%
42.50%
2 33
Building/equipment
213 000 2, 83% 188 000 42, 50%
Rent/charges Expenditure on data processing Other capital expenditure Postage and communications Other administrative expenditure
Hyra och avgifter Databehandling Övriga kapitalkostnader Porto och kommunikationer
7.82% 6.52% 2.52% 0.94% 2.78%
7, 82% 6, 52% 2, 52% 0, 94%
5 572 000 2 570 000 381 000 264 000 2 107 000
572 000 570 000 381 000 264 000
9.09% 4.19% 0.62% 0.43% 3.44%
9, 09% 4, 19% 0, 62% 0, 43%
6 275 000 6 250 000 627 000 418 000 2 083 000
275 000 8, 04% 250 000 8, 00% 627 000 0, 80% 418 000 0, 54%
20.57%
2, 78% 20, 57%
10 894 000
107 000 894 000
17.77%
3, 44% 17, 77%
15 653 000
2 15
20.05%
083 000 2, 67% 653 000 20, 05%
6.24%
3 17
3 535 000
535 000 855 500 477 000 98 500 119 000
5.77%
5, 77% 29, 13% 0, 78% 0, 16% 0, 19%
4 920 000
4 21
6.30%
EU- program
32.35% 0.65% 0.34% 0.29% 3.56%
3, 56%
17 855 500 477 000 98 500 119 000 213 000
213 000
29.13% 0.78% 0.16% 0.19% 0.34%
0, 34%
21 941 000 451 000 350 000 148 000 1 430 000
1
28.10% 0.58% 0.45% 0.19% 1.83%
430 000 1, 83%
43.43%
43, 43%
22 298 000
298 000
36.37%
36, 37%
29 240 000
29
37.45%
240 000 37, 45%
65 866 000
65 866 000 100, 00%
100.00%
61 304 000 100, 00%
100.00%
78 081 000 100, 00%
Notes (1) Final appropriations for the 2001 budget.
(1) Slutliga anslag för budgeten 2001.
(2) Final appropriations for the 2002 budget.
(2) Slutliga anslag för budgeten 2002.
(3) Budget for 2003 adopted by the Management Board on 19.12.2002.
(3) Budget för 2003 antagen av styrelsen den 19. 12. 2002.
EMEA Work Programme 2003
Följande dokument förväntas slutföras eller sändas ut på remiss under 2003.
Annex 3 EMEA guidelines for 2003 The following documents are intended to be finalised or released for consultation in 2003:
CPMP: s arbetsgrupp för bioteknik
Points to consider on clinical investigation of medicinal products for treatment of rheumatoid arthritis
Dokumenttitel Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products Points to Consider on Quality Aspects of Medicinal Products containing Active Substances Produced by Stable Transgene Expression in Higher Plants Revision of Note for guidance on minimising the risks of TSE transmission via medicinal products Points to Consider on the Development of Live Attenuated Influenza Vaccines
the treatment of irritable bowel syndrome
CPMP: s arbetsgrupp för blodprodukter
Appendix to the Note for Guidance on the Clinical investigation Document title of medicinal products in the treatment of schizophrenia Note for Guidance on the Use of Bovine Serum in the manufacture of Human Biological Medicinal Products Points to Consider on Quality Aspects of Medicinal Products
Dokumenttitel Note for Guidance on the Clinical investigation of plasma derived fibrin sealants Note for guidance on the Clinical investigation of von Willebrand factor Warning on transmissible agents for patient leaflets and SPCs Core SPC for Plasma derived fibrin sealants
containing Active Substances Produced by Stable Transgene Expression in Higher Plants
CPMP: s arbetsgrupp för läkemedelseffekt (EWP)
Points to consider on the requirements for clinical documentation for metered dose inhalers (MDI)
Dokumenttitel Points to consider on the clinical development of fibrinolytic medicinal products in the treatment of patients with ST segment elevation acute myocardial infarction (STEMI) Note for Guidance on the clinical development of medicinal products for the treatment of HIV infection.
Revision of Note for guidance on minimising the risks of TSE transmission via medicinal products Points to Consider on the Development of Live Attenuated
Note for Guidance on clinical investigation of medicinal products for the treatment of migraine.
Addendum on neuropathic pain to the Note for Guidance on clinical investigation of medicinal products for nociceptive Pain treatment
Note for Guidance on evaluation of anticancer medicinal products in man (CPMP/ EWP/ 205/ 95 rev.
Influenza Vaccines
2) – Addendum on paediatric oncology.
Note for Guidance on Clinical Investigation of Medical Products in the Treatment of Generalised Anxiety Disorder
Points to consider on the evaluation of new anti- fungal agents for invasive fungal infections.
Note for Guidance on Clinical Investigation of Medical Products CPMP Blood Product Working Party in the Treatment of Panic Disorder
Points to consider on clinical investigation of medicinal products for treatment of rheumatoid arthritis.
Document title Note for Guidance on the Clinical investigation of plasma derived
Points to consider on the evaluation of medicinal products for the treatment of irritable bowel syndrome.
Note for Guidance on Clinical Investigation of Medical Products in the Treatment of Obsessive-compulsive Disorder
Appendix to the Note for Guidance on the Clinical investigation of medicinal products in the treatment of schizophrenia (CPMP/ EWP/ 559/ 95) – methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia.
fibrin sealants Note for guidance on the Clinical investigation of von Willebrand factor Warning on transmissible agents for patient leaflets and SPCs Core SPC for Plasma derived fibrin sealants
Points to consider on the requirements for clinical documentation for metered dose inhalers (MDI) Addendum on neuropathic pain to the Note for Guidance on clinical investigation of medicinal products for nociceptive Pain treatment Note for Guidance on Clinical Investigation of Medical Products in the Treatment of Generalised Anxiety Disorder Note for Guidance on Clinical Investigation of Medical Products in the Treatment of Panic Disorder.
Addendum on acute cardiac failure to the CPMP Note for Guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure Note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia Note for Guidance on Clinical investigation of steroid contraceptives in women
Note for Guidance on Clinical Investigation of Medical Products in the Treatment of Obsessive- compulsive Disorder Addendum on acute cardiac failure to the CPMP Note for Guidance on clinical investigation of medicinal products in the treatment of acute cardiac failure Note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia Note for Guidance on Clinical investigation of steroid contraceptives in women Revision of Note for Guidance on evaluation of new anti- bacterial medicinal products (CPMP/ EWP/ 558/ 95) and Note for Guidance on the pharmacodynamic section of the summary of product characteristics for antibacterial medicinal products
Revision of Note for Guidance on evaluation of new anti- bacterial medicinal products (CPMP/EWP/558/95) and Note for
EMEA arbetsprogram för 2003 EMEA/ MB/ 057/ 02/ sv/ Slutlig Dokumenttitel
Choice of Non-
Sida 41/ 58
Note for Guidance on the clinical development of medicinal products for the treatment of HIV infection
Points to consider on Biostatistical/ methodological issues arising from CPMP discussion on licensing applications:
inferiority margin Points to consider on Biostatistical/methodological issues arising
Non- inferiority margin Points to consider on Biostatistical/ methodological issues arising from CPMP discussion on licensing applications:
Adjustment for baseline covariates
Adjustment for baseline covariates
2) – Addendum on paediatric oncology
Choice of
Points to consider on the use of statistical methods for flexible design and analysis of confirmatory clinical trials Points to consider on clinical pharmacokinetic investigation of
Points to consider on the use of statistical methods for flexible design and analysis of confirmatory clinical trials Points to consider on clinical pharmacokinetic investigation of the pharmacokinetics of peptides and proteins Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function Points to consider on the evaluation of the pharmacokinetics of medicinal products in the paediatric population Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with hepatic impairment Note for guidance on clinical investigation of medicinal products for the treatment of psoriasis Points to consider on allergic rhino- conjuctivitis Addendum to the Note For Guidance on Modified Release Oral and Transdermal Dosage Forms:
the pharmacokinetics of peptides and proteins Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function
Section II (PharmacoKinetic and Clinical Evaluation) on the clinical requirements of modified release products submitted as a line - extension of an existing marketing authorisation Points to consider on Xenogenic Cell Therapy Note for Guidance on Comparability of Medicinal Products containing biotechnology - derived proteins as active substance Note for Guidance on the use of medicinal products during pregnancy Note for Guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling
Chapter 1 EMEA in the European system
CPMP: s arbetsgrupp för säkerhet
Points to consider on the evaluation of the pharmacokinetics of medicinal products in the paediatric population Note for guidance on the evaluation of the pharmacokinetics of
Dokumenttitel Position Paper on the Non- clinical safety studies to support clinical trials with a single low dose of a compound Note for Guidance on specification limits for residues of metal catalysts Note for Guidance on Comparability of Medicinal Products Containing Biotechnology- derived Proteins as Drug Substance:
medicinal products in patients with hepatic impairment Note for guidance on clinical investigation of medicinal products
Annex on Non- Clinical and Clinical Considerations Note for Guidance on the Non- Clinical Documentation of Medicinal Products with Well- Established Use Position Paper on the limits of genotoxic impurities Note for Guidance on the Need for Pre- clinical Testing of Human Pharmaceuticals in Juvenile Animals Note for Guidance on Environmental Risk Assessments for Pharmaceuticals
Section II (PharmacoKinetic and Clinical Evaluation) on the clinical requirements of modified
CPMP: s arbetsgrupp för biverkningsbevakning
CPMP Points-to-Consider Document on Xenogeneic Cell Therapy (CPMP/1199/02) ICH-V1:
Dokumenttitel Note for Guidance on Criteria for Recall and Repackaging Following Urgent Safety Restriction and Variation Procedures CPMP Points- to- Consider Document on Xenogeneic Cell Therapy (CPMP/ 1199/ 02) ICH- V1:
Note for guidance on non-clinical testing of herbal drug
EMEA arbetsprogram för 2003 EMEA/ MB/ 057/ 02/ sv/ Slutlig CPMP: s arbetsgrupp för naturläkemedel
CPMP Safety Working Party Document title
Sida 42/ 58
preparations with long-term marketing experience - guidance to facilitate mutual recognition and use of bibliographic data Concept paper for a Note for Guidance on the investigation of
Dokumenttitel Note for guidance on non- clinical testing of herbal drug preparations with long- term marketing experience - guidance to facilitate mutual recognition and use of bibliographic data Concept paper for a Note for Guidance on the investigation of biopharmaceutical characterisation and bioavailability/ bioequivalence of herbal drugs/ preparations Position paper on the risk associated with the use of herbal products containing estragole Position paper on the risk associated with the use of herbal products containing methyleugenol Position paper on the risk associated with the use of herbal products containing á - and β- asarone Position paper on the use of Sassafras albidum as active substance or ingredient in herbal medicinal products
Position Paper on the Non-clinical safety studies to support clinical trials with a single low dose of a compound Note for Guidance on specification limits for residues of metal catalysts Note for Guidance on Comparability of Medicinal Products Containing Biotechnology-derived Proteins as Drug Substance:
Concept paper on the levels of scientific evidence required for the authorisation of well- established use and traditional herbal medicinal products Core- data on Urticae radix Core- data on Lini semen Core- data on Rosmarini folium cum flore Core- data on Primulae Radix
Annex on Non-Clinical and Clinical Considerations
CVMP: s arbetsgrupp för läkemedelseffekt
biopharmaceutical characterisation and bioavailability/ bioequivalence of herbal drugs/preparations Position paper on the risk associated with the use of herbal products containing estragole Position paper on the risk associated with the use of herbal products containing methyleugenol Position paper on the risk associated with the use of herbal
Dokumenttitel Antimicrobials for general use in target animal species Summary of product characteristics for antimicrobial products Efficacy requirements for ectoparasiticides for cattle Fluid therapy
Note for Guidance on the Non-Clinical Documentation of Medicinal Products with Well-Established Use
CVMP: s arbetsgrupp för immunologiska läkemedel
products containing α- and β-asarone Position paper on the use of Sassafras albidum as active
Target animal safety for veterinary biological products VICH:
Position Paper on the limits of genotoxic impurities Note for Guidance on the Need for Pre-clinical Testing of Human Pharmaceuticals in Juvenile Animals Note for Guidance on Environmental Risk Assessments for Pharmaceuticals
CVMP: s arbetsgrupp för biverkningsbevakning
substance or ingredient in herbal medicinal products Concept paper on the levels of scientific evidence required for the authorisation of well-established use and traditional herbal medicinal products Core-data on Urticae radix
Pharmacovigilance of veterinary medicinal products:
Core-data on Lini semen
Controlled list of terms VICH:
Core-data on Rosmarini folium cum flore
Pharmacovigilance of veterinary medicinal products:
Core-data on Primulae Radix
Electronic standards for transfer of data
EMEA Work Programme 2003
EMEA arbetsprogram för 2003 EMEA/ MB/ 057/ 02/ sv/ Slutlig CVMP: s arbetsgrupp för säkerhet
Document title
Sida 43/ 58
Document title
Dokumenttitel VICH:
Estimation of predicted environmental concentrations, including
CPMP: s och CVMP: s gemensamma arbetsgrupp för kvalitetsfrågor
Joint CPMP/CVMP Quality Working Party Document title Use of near infrared spectroscopy by the pharmaceutical industry Modified release oral and transdermal dosage forms Revision:
Dokumenttitel Use of near infrared spectroscopy by the pharmaceutical industry Modified release oral and transdermal dosage forms Revision:
Stability testing of new active substances
EMEA arbetsprogram för 2003 EMEA/ MB/ 057/ 02/ sv/ Slutlig Bilaga 4 EMEA: s kontaktpunkter
VICH:
Sida 44/ 58
Stability testing of existing active
Biverkningsbevakning och rapportering om produktdefekter
viral vaccines
EMEA får in säkerhetsrapporter från EU- länderna och andra länder om centralt godkända läkemedel och samordnar den verksamhet som rör läkemedels säkerhet och kvalitet.
substances and related finished products
Frågor rörande biverkningsbevakning avseende humanläkemedel
Summary of requirements for active substances
Panos TSINTIS Tfn direkt (44- 20) 75 23 71 08 E- post: panos. tsintis@ emea. eu. int
Process validation (update) CVMP Pharmacovigilance Working Party Quality aspects of veterinary medicinal products administered via Document title VICH:
Frågor rörande biverkningsbevakning avseende veterinärmedicinska läkemedel
Management of adverse event reports
Barbara FREISCHEM Tfn direkt (44- 20) 74 18 85 81 E- post: barbara. freischem@ emea. eu. int
drinking water
Produktdefekter och andra kvalitetsfrågor
Pharmacovigilance of veterinary medicinal products:
E- post: qualitydefects@ emea. eu. int Fax (44- 20) 74 18 85 90 Tfn utanför kontorstid:
Controlled list of terms
Läkemedelscertifikat
Electronic standards for transfer of data 36 EMEA Work Programme 2003
I enlighet med WHO: s regler utfärdar EMEA läkemedelscertifikat där godkännande för försäljning och GMP- status i EU intygas.
Annex 4 Chapter 1 EMEA in the European system contact points
Certifikaten är avsedda att användas som stöddokumentation vid ansökan om godkännande för försäljning i länder utanför EU och vid export till sådana länder.
Pharmacovigilance and product defect reporting
Frågor rörande certifikat för centralt godkända humanläkemedel och veterinärmedicinska läkemedel
Documentation services A wide range of documents has now been published by the
Jonna SUNELL- HUET Tfn direkt (44- 20) 74 18 84 65 E- post: certificate@ emea. eu. int
The constant monitoring of the safety of medicines after authorisation (‘pharmacovigilance’) is an important part of the work of the national competent authorities and EMEA.
Dokumentservice
EMEA, including press releases, general information documents, annual reports and work programmes.
EMEA har nu publicerat ett stort antal dokument, bl. a. pressmeddelanden, allmän information, årsrapporter och arbetsprogram.
EMEA Documentation Service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus
EMEA Documentation service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf London E14 4H – Storbritannien
For matters relating to pharmacovigilance for medicinal products for human use
Mer information kan erhållas från adressen ovan eller från
For matters relating to pharmacovigilance for medicinal products for veterinary use Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara.freischem@emea.eu.int
Informationspaket kan rekvireras från
Requests for general information packs should be sent to Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda.bosworth@emea.eu.int
Amanda BOSWORTH Tfn direkt (44- 20) 74 18 84 08 E- post: amanda. bosworth@ emea. eu. int
For product defect and other quality-related matters European experts list E-mail: qualitydefects@emea.eu.int
EMEA arbetsprogram för 2003 EMEA/ MB/ 057/ 02/ sv/ Slutlig Förteckning över europeiska experter
(44-7880) 55 06 97
Sida 45/ 58
Approximately 3 000 are used by the EMEA in its scientific evaluation work.
EMEA anlitar omkring 3 000 experter för arbetet med vetenskapliga utvärderingar.
The list of these European experts is available for examination on request at the EMEA offices.
En förteckning över europeiska experter finns tillgänglig och kan på begäran studeras på EMEA: s kontor.
E-mail: europeanexperts@emea.eu.int
E- post: europeanexperts@ emea. eu. int
Integrated quality management
Integrerad kvalitetsstyrning
applications in and export to non-EU countries.
Sakkunnig för integrerad kvalitetsstyrning (IQM)
Marijke KORTEWEG Direct telephone (44-20) 74 18 85 56 E-mail: iqmanagement@emea.eu.int
Marijke KORTEWEG Tfn direkt (44- 20) 74 18 85 56 E- post: iqmanagement@ emea. eu. int
Martin HARVEY ALLCHURCH Direct telephone (44-20) 74 18 84 27 E-mail: martin.harvey-allchurch@emea.eu.int
Martin HARVEY ALLCHURCH Tfn direkt (44- 20) 74 18 84 27 E- post: martin. harvey- allchurch@ emea. eu. int
Annex 5 Chapter 1 Profiles the European system EMEA inof EMEA personalities
EMEA arbetsprogram för 2003 EMEA/ MB/ 057/ 02/ sv/ Slutlig Bilaga 5 Presentation av befattningshavare inom EMEA
British
Sida 46/ 58
Philippe Duneton, Vice-chairman of the Management Board, b.
Keith Jones, styrelsens ordförande.
French
Född 371014, brittisk medborgare
Dr Duneton qualified as a doctor in medicine from the University of Paris VI, Faculty de Lariboisière Saint Louis.
Läkarexamen och olika befattningar inom klinisk medicin och forskning vid brittiska undervisningssjukhus.
He is a former house doctor and former assistant head of section for Paris Hospitals.
Därefter utbildning till toxikolog inom den jordbrukskemiska branschen.
He is currently visiting Professor of Pharmacology at the School of Pharmacy University of London and has published widely.
Är för närvarande gästprofessor i farmakologi vid School of Pharmacy (London) och är författare till en rad publikationer.
Dr Jones joined the EMEA Management Board in 1995.
Blev ledamot av EMEA: s styrelse 1995.
He was first elected chairman of the Board in 2001 and re-elected chairman in 2003.
Valdes till dess ordförande 2001 och omvaldes till dess ordförande 2003.
From 1992 to 1993, Dr Duneton was technical advisor for public health in the Cabinet of the French Minister responsible for health and humanitarian action.
Mellan 1992 och 1993 teknisk rådgivare för folkhälsa i franska ministerkabinettet för hälsa och humanitära åtgärder.