qanastek/EMEA-V3 huggingface dataset:
- 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
- Ontwikkeling en implementatie van upgrades van op maat gemaakte en aangepaste toepassingen die bij het EMEA in productie zijn overeenkomstig de door het EMEA- bestuur vastgestelde prioriteiten - (Voortzetting van de) ontwikkeling van nieuwe toepassingen overeenkomstig de door het EMEA-bestuur vastgestelde prioriteiten
Scientific memory database; Scientific advice database; Orphan drug database; experts database; ActiTrak Meetings management system
Wetenschappelijke database; database wetenschappelijke adviezen; database weesgeneesmiddelen; database deskundigen; ActiTrak Vergaderingenbeheersysteem
Project support and management
Projectonder- steuning en - beheer
- Technical support in the development and implementation of major projects
- Technische steun bij de ontwikkeling en uitvoering van grote projecten
PIM and the eCTD; SIAMED; electronic document management system
PIM en eCTD, SIAMED; elektronisch documentbeheersysteem
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 European initiatives and activities
41/64 Europese initiatieven en activiteiten
The IT sector will undertake the activities set out below in support of the European initiatives and activities
De IT-sector zal onderstaande taken verrichten ter ondersteuning van de Europese initiatieven en activiteiten
Initiative EudraNet
Initiatief EudraNet
Activities - Preparation for the assumption of operational responsibility from January 2003 - Chair of the EudraNet Telematics Implementation Group
Activiteiten - Voorbereiding op operationele taken vanaf januari 2003 - Voorzitterschap van de werkgroep Implementatie EudraNet
- 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
- Operationele ondersteuning teneinde 99% systeembeschikbaarheid te waarborgen - Leiding geven aan en ondersteunen van contractanten voor de tenuitvoerlegging van de projectfases 2 en 3, met inbegrip van de elektronische gateway - Coördinatie van de testgroep van deelnemers uit de lidstaten en de industrie - Voorzitterschap van de werkgroep Implementatie EudraVigilance
EuroPharm database
Database EuroPharm
- 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
- Technische bijstand bij de specificatie van het gegevensmodel en de gebruikerseisen - Technische bijstand ten behoeve van een adequate overeenstemming van definities van gegevensvelden in alle pan-Europese projecten - Technische bijstand bij de testinstallatie van de database samen met de aangewezen ontwikkelaar
Electronic submission
Elektronische indiening -
- 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
Technische bijstand en steun bij het opzetten van de noodzakelijke systemen voor de ontvangst van elektronische inzendingen in overeenstemming met het eCTD
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annexes
Technische bijstand en steun bij de definitie en implementatie van de toepassingen die noodzakelijk zijn om de elektronisch ingediende gegevens te verwerken
 EMEA 2002 Page 40/ 62
42/64 Bijlagen
EMEA establishment plan 2000 – 2002
EMEA-formatieplan 2000 – 2002
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 1 EMEA establishment plan 2000 – 2002
43/64 Bijlage 1 EMEA-formatieplan 2000 – 2002
Occupied as at 31.12.2000
(per 31.12.2000)
Authorised for Occupied as at 2001 31.12.2001
Goedgekeurd voor 2001
Authorised for 2002
Goedgekeurd voor 2002
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
A4 A5 A6 A7 A8 TOTAAL A B1 B2 B3 B4 B5 TOTAAL B C1 C2 C3 C4 C5 TOTAAL C D1 D2 D3 D4 TOTAAL D
24 22 25 23 -- 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
29 27 25 24 -- 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
26 24 24 24 -- 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
29 28 29 30 -- 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
TOTAL POSTS
TOTAAL AANTAL FORMATIE- PLAATSEN
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Allocation of posts
44/64 Toewijzing van formatieplaatsen
Allocation in 2001
Toewijz ing in 2001
Directorate and financial control Administration Unit
Directie en financiële controle Eenheid Administratie
Directorate total
Totaal Directie
Head of Unit team Sector for Personnel and budget Sector for Infrastructure services Sector for Accounting Reserve posts
Hoofd van de eenheid Sector Personeelszaken en begroting Sector Infrastructuur Sector Boekhouding Reserveplaatsen
Unit total
Totaal eenheid
Unit for the Pre-authorisation Evaluation of Medicines for Human Use Head of Unit team
Eenheid Beoordeling van geneesmiddelen voor menselijk gebruik vóór de vergunningverlening Hoofd van de eenheid
Sector for Scientific advice and orphan drugs Sector for Quality of medicines Sector for Safety and efficacy of medicines Reserve posts
Sector Wetenschappelijk advies en weesgeneesmiddelen
Unit for the Post-authorisation Evaluation of Medicines for Human Use Head of Unit team
Eenheid Beoordeling van geneesmiddelen voor menselijk gebruik na vergunningverlening Hoofd van de eenheid
Sector for Regulatory affairs and organisational support
Sector Registratiezaken en organisatorische steun Sector Geneesmiddelenbewaking en veiligheid en werkzaamheid na vergunningverlening
Reserve posts Unit total Unit for Veterinary Medicines and Inspections
Reserveplaatsen Totaal eenheid
Head of Unit team Sector for Veterinary marketing authorisation procedures
Eenheid Geneesmiddelen voor diergeneeskundig gebruik en inspecties Hoofd van de eenheid
4 8
8
Sector for Safety of veterinary medicines Sector for Inspections Reserve posts Unit total Communication and Networking Unit
Sector Veiligheid van diergeneesmiddelen Sector Inspecties Reserveplaatsen Totaal eenheid Eenheid Communicatie en networking
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
Hoofd van de eenheid Sector Documentbeheer en publicaties Sector Beheer vergaderingen en conferenties Sector Projectbeheer Sector Informatietechnologie Reserveplaatsen Totaal eenheid Extra algemene reserveplaatsen
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 2 EMEA budget summaries 2000 – 2002
Totaal aantal formatieplaatsen
 EMEA 2002 Page 43/ 62
45/64 Bijlage 2 EMEA-begrotingsoverzichten 2000 – 2002
The summarised comparative budget statements for 2000 to 2002 are as follows:
Hierna volgt een samenvattend vergelijkend overzicht van de staat van ontvangsten en uitgaven over de jaren 2000 - 2002:
Fees General EU contribution Special EU orphan medicinal
Vergoedingen Algemene EU-bijdrage Speciale EU-bijdrage
70.82% 23.88%
70,82% 2,. 88%
product contribution Contribution from EEA Contribution from EU
weesgeneesmiddelen EER-bijdrage Bijdrage uit EU-programma´s
314 360
2 314 360
2.31%
1
866 000 100.00%
65 866 000 100,00%
547 000
70 547 000
Salaries Interim and other support persons Other staff-related expenditure Total title 1 Building/ equipment
Uitgaven Personeel Salarissen Uitzendkrachten en overig
20 1 1 23
33,45%
615 000 31.30% 414 000 2.15% 683 640 2.56% 712 640 36.00%
20 615 000
24 1 1 28
31,30%
952 000 905 000 776 000 633 000
24 952 000
35.37% 2.70% 2.52% 40.59%
35,37%
Rent/ charges Expenditure on data processing Other capital expenditure Postage and communications
ondersteunend personeel Andere personeelsuitgaven Totaal titel 1 Gebouwen/apparatuur
212 220 423 500 353 000 480 000
1 058 000 1 350 000 20 901 000
9.43% 4.38% 4.26% 0.87%
1,91% 2,44% 39,80%
149 000 7.82% 293 000 6.52% 658 000 2.52% 617 000 0.94%
1 414 000 1 683 640 23 712 640
5 2 1
2,15% 2,56% 36,00%
936 000 570 000 170 000 394 000
1 905 000 1 776 000 28 633 000
8.41% 3.64% 1.66% 0.56%
2,70% 2,52% 40,59%
Other administrative expenditure Total title 2 Operational expenditure
Huur en vaste lasten Uitgaven voor
2.88% 21.82%
5 212 220
1 13
9,43%
829 000 2.78% 546 000 20.57%
5 149 000
1 11
7,82%
925 000 995 000
5 936 000
2.73% 17.00%
8,41%
Meetings Evaluations Translation Studies and consultants Publications
gegevensverwerking Overige kapitaaluitgaven Porto en communicatie Overige administratieve uitgaven Totaal titel 2 Beleidsuitgaven
5 000 150 000
2 423 500 2 353 000 480 000 1 593 000 12 061 720
5.92% 33.79% 0.00% 0.01% 0.27%
4,38% 4,26% 0,87% 2,88% 21,82%
110 000 6.24% 308 000 32.35% 428 000 0.65% 225 000 0.34% 190 000 0.29%
4 293 000 1 658 000 617 000 1 829 000 13 546 000
4 23
6,52% 2,52% 0,94% 2,78% 20,57%
320 000 333 000 359 000 85 000 190 000
2 570 000 1 170 000 394 000 1 925 000 11 995 000
6.12% 33.07% 0.51% 0.12% 0.27%
3,64% 1,66% 0,56% 2,73% 17,00%
Total title 3
Vergaderingen Beoordelingen Vertalingen Studies en adviezen Publicaties EU-programma’ s Totaal titel 3
324 500
3 270 000 18 682 500 p, m, 5 000 150 000 217 000 22 324 500
40.38%
5,92% 33,79% 0,00% 0,01% 0,27% 0,39% 40,38%
607 360 43.43%
4 110 000 21 308 000 428 000 225 000 190 000 2 346 360 28 607 360
29
6,24% 32,35% 0,65% 0,34% 0,29% 8,20% 43,43%
919 000
4 320 000 23 333 000 359 000 85 000 190 000 1 632 000 29 919 000
42.41%
6,12% 33,07% 0,51% 0,12% 0,27% 2,31% 42,41%
100.00%
(1) Begroting 2000: eindresultaat (2) Begroting 2001: eindresultaat
(2) Final appropriations for 2001.
(3) Begroting 2002, zoals goedgekeurd door de raad van beheer op 18 december 2001,
(3) Budget for 2002 as adopted by the Management Board on 18.12.2001.
46/64 Bijlage 3 EMEA-richtsnoeren, 2002
The following documents are intended to be finalised or released for consultation in 2002.
Gepland is dat onderstaande documenten in 2002 worden voltooid of vrijgegeven voor overleg
CPMP Biotechnology Working Party
CPMP-werkgroep Biotechnologie
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:
Titel document 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:
CPMP Blood Products Working Party
CPMP-werkgroep Bloedproducten
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:
Titel document 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 rabies 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)
 EMEA 2002 Page 45/ 62
47/64 CPMP-Werkgroep Werkzaamheid
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:
Titel document 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 the 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 baseline covariates Points to consider on the clinical investigation of medicinal products in the treatment of asthma Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence in women Note for guidance on the evaluation of medicinal products for treatment of migraine Appendix to the CPMP Note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia, on methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia Note for guidance on the evaluation of medicinal products indicated for thrombolysis in acute myocardial infarction 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 Points to consider on clinical investigation of slow-acting anti-rheumatic medicinal products in rheumatoid arthritis Points to consider on irritable bowel syndrome Points to consider document on the evaluation of new anti-fungal agents for invasive fungal infections 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 baseline covariates Points to consider on clinical investigation of medicinal products in the treatment of asthma Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence in women Note for guidance on the evaluation of medicinal products for treatment of migraine Appendix to the CPMP Note for guidance on the clinical investigation of medicinal products in the treatment of schizophrenia, on methodology of clinical trials concerning the development of depot preparations of approved medicinal products in schizophrenia Note for guidance on the evaluation of medicinal products indicated for thrombolysis in acute myocardial infarction 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 treatment of dyslipoproteinaemia Points to consider on clinical investigation of slow-acting anti-rheumatic medicinal products in rheumatoid arthritis Points to consider on irritable bowel syndrome Points to consider document on the evaluation of new anti-fungal agents for invasive fungal infections Points to consider on biostatistical/methodological issues arising from CPMP discussion on licensing applications:
Choice of delta Points to consider on the requirements for clinical documentation for metered dose inhalers Addenda for neuropathic pains to be considered Clinical investigation of hypnotic medicinal products Clinical Investigation of Medical Products in the Treatment of Generalised Anxiety Disorder, Panic Disorder and Obsessive-compulsive DisorderRevision Note for guidance on Anthiarrhythmics Note for guidance on Clinical investigation of steroid contraceptives in women Clinical Investigation of Corticosteroids Intended for use on the Skin.
Choice of delta Points to consider on the requirements for clinical documentation for metered dose inhalers Addenda for neuropathic pains to be considered Clinical investigation of hypnotic medicinal products Clinical Investigation of Medical Products in the Treatment of Generalised Anxiety Disorder, Panic Disorder and Obsessive-compulsive DisorderRevision Note for Guidance on Anthiarrhythmics Note for Guidance on clinical investigation of steroid contraceptives in woman Clinical Investigation of Corticosteroids Intended for use on the Skin.
Note for guidance on Pharmacokinetic Studies in man Points to consider on Live attenuated influenza vaccines Guidance on requirements for pharmaceutical/ clinical documentation for Cell culture influenza vaccines Points to consider on xenogeneic 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: need for post-marketing data Note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling Revision of the Note for guidance on harmonisation of requirements for influenza vaccines
Note for guidance on Pharmacokinetic Studies in man Points to consider on live-attenuated influenza vaccines Guidance on requirements for pharmaceutical/clinical documentation for Cell culture influenza vaccines Points to consider on xenogeneic 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: need for post-marketing data Note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling Revision of the Note for guidance on harmonisation of requirements for influenza vaccines
 EMEA 2002 Page 46/ 62
48/64 CPMP-Werkgroep Veiligheid
Document title Revision of Note for guidance on carcinogenic potential (3BS7a, Volume 3B, 1998, p.
Titel document Revision of Note for guidance on carcinogenic potential (3BS7a, Volume 3B, 1998, p.
63) Note for guidance on photosafety testing Points to consider document on the need for assessment of reproductive toxicity of human insulin analogues Discussion paper on environmental risk assessments of non-GMO containing medicinal products for human use Non-clinical documentation of medicinal products with ‘ well-established use’ Note for guidance on the need for non-clinical testing of pharmaceuticals in juvenile animals Discussion paper on the non-clinical safety studies to support single low dose clinical screening studies in man Note for guidance on specification limits for residues for heavy metal catalysts in medicinal products Points to consider on xenogeneic cell therapy Note for guidance on comparability of biotechnology products pre-clinical and clinical issues
63) Note for guidance on photosafety testing; Points to consider document on the need for assessment of reproductive toxicity in the development of human insulin analogues Discussion paper on environmental risk assessments of non-GMO containing medicinal products for human use Non-clinical documentation of medicinal products with ‘ well-established use’ Note for guidance on the need for non-clinical testing of pharmaceuticals in juvenile animals Discussion paper on the non-clinical safety studies to support single low dose clinical screening studies in man Note for guidance on specification limits for residues for heavy metal catalysts in medicinal products Points to consider on xenogeneic cell therapy Note for guidance on comparability of biotechnology products pre-clinical and clinical issues Points to consider on the assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products Note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling
CVMP Efficacy Working Party
CVMP-Werkgroep Werkzaamheid
Document title Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy
Titel document Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy
CPMP Pharmacovigilance Working Party
CVMP-Werkgroep Geneesmiddelenbewakning
Document title Revision of Note for guidance on the conduct of pharmacovigilance for centrally authorised products Revision of crisis management plan regarding centrally authorised products for human use Guidance document for the implementation of the position paper on compliance with pharmacovigilance regulatory obligations Contribution to Note for guidance on the use of medicinal products during pregnancy:
Titel document Revision of Note for guidance on the conduct of pharmacovigilance for centrally authorised products Revision of crisis management plan regarding centrally authorised products for human use Guidance document for the implementation of the position paper on compliance with pharmacovigilance regulatory obligations Contribution to Note for guidance on the use of medicinal products during pregnancy:
CVMP Immunologicals Working Party
49/64 CVMP-Werkgroep Immunologische preparaten
Document title Harmonisation requirements for low and high potency and batch consistency of vaccines Harmonisation requirements for low and high potency and batch consistency of vectored vaccines Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products Revision: transmissible spongiform encephalopathy Revision: compliance with the European Pharmacopoeia Revision: equine influenza Revision: claims for veterinary vaccines VICH:
Titel document Harmonisation requirements for low and high potency and batch consistency of vaccines Harmonisation requirements for low and high potency and batch consistency of vectored vaccines Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products Revision: transmissible spongiform encephalopathy Revision: compliance with the European Pharmacopoeia Revision: equine influenza Revision: claims for veterinary vaccines VICH:
 EMEA 2002 Page 47/ 62
CVMP-Werkgroep Geneesmiddelenbewaking
Document title VICH:
Titel document VICH:
Document title Safety evaluation of antimicrobial substances regarding the effects on human gut flora VICH:
Titel document Safety evaluation of antimicrobial substances regarding the effects on human gut flora VICH:
Document title In-use stability testing of veterinary medicinal products Use of near infrared spectroscopy by the pharmaceutical industry Modified release oral and transdermal dosage forms Revision:
Titel document In-use stability testing of veterinary medicinal products Use of near infrared spectroscopy by the pharmaceutical industry Modified release oral and transdermal dosage forms Revision:
Pharmacovigilance and product defect reporting
50/64 Bijlage 4 EMEA-contactpersonen Geneesmiddelenbewaking en melding van productgebreken
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.
Het permanente toezicht op de veiligheid van geneesmiddelen na de vergunningverlening (‘ geneesmiddelenbewaking’) is een belangrijk onderdeel van het werk van de nationale bevoegde instanties en het EMEA.
Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eu. int
(44-20) 74 18 85 92 E-mail: noel.wathion@emea.eu.int
Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara. freischem@emea. eu. int
(44-20) 74 18 85 81 E-mail: barbara.freischem@emea.eu.int
For product defect and other quality-related matters
Voor productgebreken en andere kwaliteitsproblemen
Francisco PEÑARANDA FERNANDEZ Fax number for defective product rapid alerts (44-20) 74 18 85 90 E-mail: francisco. penaranda@emea. eu. int
(44-20) 74 18 85 90 E-mail: francisco.penaranda@emea.eu.int
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organisation.
Het EMEA geeft geneesmiddelencertificaten uit in overeenstemming met de voorschriften van de Wereldgezondheidsorganisatie.
These certify the marketing authorisation and good manufacturing status of medicinal products in the EU and are intended for use in support of marketing authorisation applications in and export to non-EU countries.
Ze worden gebruikt om aanvragen voor het in de handel brengen van geneesmiddelen in niet-EU-landen en de export naar die landen te ondersteunen.
For enquiries concerning certificates for centrally authorised medicines for human or veterinary use
Voor vragen over certificaten voor centraal toegelaten geneesmiddelen voor menselijk gebruik
Jonna SUNELL-HUET Direct telephone (44-20) 74 18 84 65 E-mail: certificate@emea. eu. int
(44-20) 74 18 84 65 E-mail: certificate@emea.eu.int
Documentation services
Documentatie
A wide range of documents has now been published by the EMEA, including press releases, general information documents, annual reports and work programmes.
Het EMEA heeft een grote verscheidenheid aan documenten gepubliceerd, waaronder persberichten, documenten met algemene informatie, jaarverslagen en werkprogramma's.
These and other documents are available either on the Internet at http: / /www. emea. eu. int or by writing to:
Deze en andere documenten zijn te verkrijgen op het Internet, http://www.emea.eu.int, of kunnen schriftelijk worden aangevraagd bij:
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 A subscription service is available for all EMEA public documents, distributing documents electronically or in paper form.
51/64 De afdeling Abonnementen levert alle voor het publiek toegankelijke EMEA-documenten op papier of in elektronische vorm.
 EMEA 2002 Page 49/ 62
Nadere inlichtingen kunnen worden verkregen op bovenstaand adres of van
Further information can be obtained from the Iro MAVROPOULOS
Iro MAVROPOULOS Doorkiesnummer:
above address or from Direct telephone (44-20) 74 18 85 E-mail: subscriptions@emea. eu. int
(44-20) 74 18 85 82 E-mail: subscriptions@emea.eu.int
Requests for general information packs should be sent to
Algemene informatiepaketten kunnen worden aangevraagd bij
Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda. bosworth@emea. eu. int
(44-20) 74 18 84 08 E-mail: amanda.bosworth@emea.eu.int
European experts lists
Europese deskundigenlijsten
The list of European experts is available for examination on request at the EMEA offices.
De lijst van Europese deskundigen kunnen ten kantore van het EMEA op verzoek worden geraadpleegd.
Requests may be made either in writing to the EMEA or sent to the following e-mail addresses:
Aanvragen kunnen schriftelijk worden ingediend bij het EMEA of naar het volgende e- mailadres worden gezonden:
Human medicines’ experts list
Deskundigenlijst inzake geneesmiddelen voor menselijk gebruik
human_experts@emea. eu. int
human_experts@emea.eu.int
Veterinary medicines ’ experts list
Deskundigenlijst inzake diergeneesmiddelen
vet_experts@emea. eu. int
vet_experts@emea.eu.int
Inspectors ’ experts list
Deskundigenlijst van inspecteurs
inspectors_experts@emea. eu. int
inspectors_experts@emea.eu.int
Press office
Persvoorlichting
Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin. harvey@emea. eu. int
(44-20) 74 18 84 27 E-mail: martin.harvey@emea.eu.int
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 5 Profiles of EMEA personalities
52/64 Bijlage 5 Biografische gegevens van het EMEA-kader
Keith Jones, Chairman of the Management Board, b.
Keith Jones, voorzitter van de raad van beheer, geb.
British
14 oktober 1937, Britse nationaliteit
Dr Jones is qualified in medicine and has held posts in clinical medicine and research at UK teaching hospitals.
Jones is afgestudeerd in de geneeskunde en bekleedde een aantal functies binnen opleidingsziekenhuizen in het Verenigd Koninkrijk op de werkterreinen klinische geneeskunde en onderzoek.
Dr Jones went on to spend 22 years in industry as Head of the Medical Department at Fisons Agrochemical Divisions, Head of Safety Assessment and Clinical Pharmacology at Beecham Pharmaceuticals and Executive Director, Medical Affairs at Merck Sharp and Dohme in the USA.
Jones was gedurende 22 jaar in de industrie werkzaam als hoofd van de medische afdeling van Fisons Agrochemical Divisions, als hoofd Veiligheidsbeoordeling en klinische farmacologie bij Beecham Pharmaceuticals en als medisch directeur bij Merck Sharp and Dohme in de VS.
In 1991 Dr Jones was appointed Chief Executive of the UK Medicines Control Agency, and is presently the UK delegate to the EU Pharmaceutical and Standing Regulatory Committees, and a member of the EU Scientific Steering Committee within the European Commission Directorate-General for Public health and consumer protection.
Hij is momenteel de Britse afgevaardigde in het farmaceutisch en het permanent regelgevend comité van de EU en lid van de wetenschappelijke stuurgroep binnen het directoraat-generaal Gezondheids- en Consumentenbescherming van de Europese Commissie.
Gerhard Josef Kothmann, Vice-Chairman of the Management Board, b.
Gerhard Kothmann, vice-voorzitter van de raad van beheer, geb.
German
23 juli 1943, Duitse nationaliteit
Qualified veterinary surgeon from the University of Hanover.
Afgestudeerd in de diergeneeskunde aan de Universiteit van Hannover.
After a period of general veterinary practice, Dr Kothmann joined the German Federal Research Centre for Animal Virus Diseases in 1970 and the veterinary administrative service for Lower Saxony in 1972.
Kothmann in 1970 aangesteld bij het Federale Onderzoekscentrum voor virusziekten bij dieren en in 1972 bij de diergeneeskundige dienst voor Nedersaksen.
He moved to the German Federal Ministry for Health in 1975 where he has served in various posts, including in the division responsible for veterinary pharmaceutical sector, and in 1990 he collaborated in the reconstruction of the veterinary services in the new federal Länder.
In 1975 ging hij naar het Duitse federale Ministerie van Gezondheid waar hij verschillende functies bekleedde, onder andere op de afdeling Diergeneesmiddelen, en in 1990 werkte hij mee aan de reorganisatie van de diergeneeskundige diensten in de nieuwe federale deelstaten.
He was appointed Chief Veterinary Officer in 1991.
In 1991 werd hij benoemd tot veterinair hoofdambtenaar.
Dr Kothmann joined the EMEA Management Board in 1996 and was elected vice-chairman in 2000.
Kothmann toe tot de raad van beheer van het EMEA en in 2000 werd hij tot vice-voorzitter gekozen.
Qualified pharmacist from the University of Uppsala Faculty of Pharmacy.
Afgestudeerd als apotheker aan de faculteit Farmacie van de Universiteit van Uppsala.
Mr Lönngren was with the National Board of Health and Welfare, Sweden, from 1978 to 1990 during which time he was responsible for herbal medicines, cosmetics, medical devices, narcotics and contraceptives.
In deze periode was hij verantwoordelijk voor kruidengeneesmiddelen, kosmetische producten, medische apparatuur, verdovende middelen en voorbehoedsmiddelen.
He acted as senior pharmaceutical consultant for the Swedish health cooperation programme in Vietnam from 1982 to 1994.
Van 1982 tot 1994 was hij farmaceutisch hoofdadviseur in het kader van het Zweedse programma voor samenwerking op het gebied van gezondheid in Vietnam.
He joined the Swedish Medicinal Products Agency in 1990, serving as Director of Operations and later as Deputy Director-General.
In 1990 ging hij naar het Zweeds geneesmiddelenbureau. waar hij werkzaam was als directeur productieactiviteiten en vervolgens als plaatsvervangend directeur-generaal.
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 EMEA scientific committees
53/64 Wetenschappelijke comités van het EMEA
Daniel Brasseur, Chairman of the CPMP, b.
Daniel Brasseur, voorzitter van het CPMP, geb.
Belgian
7 juni 1951, Belgische nationaliteit
Qualified medical doctor from the Free University of Brussels.
Afgestudeerd als arts aan de Vrije Universiteit van Brussel.
Post-graduate degree in paediatrics and a PhD in nutrition.
Specialisatie in kindergeneeskunde en gepromoveerd in de voedingsleer.
From 1976 to 1986 Dr Brasseur worked as a paediatrician at the University Sint Pieter Hospital in Brussels.
Brasseur kinderarts bij het academisch ziekenhuis St.-Pieter in Brussel.
He moved briefly to the pharmaceutical industry from 1986 to 1987, before returning to clinical work at the Queen Fabiola Children’ s University Hospital in Brussels as head of the nutrition and pharmacodynamics unit, a post he continues to hold today.
Deze functie bekleedt hij nog steeds.
He joined the Pharmaceutical Inspectorate of the Belgian Ministry of Public Health as head of medical assessors in 1997.
Hij kwam in 1997 bij de dienst Farmaceutische inspectie van het Belgische Ministerie van Sociale Zaken en Volksgezondheid als hoofd van de medische adviseurs.
Dr Brasseur has held a number of teaching posts and is currently professor of nutrition and related diseases at the Free University of Brussels.
Brasseur bekleedde een aantal onderwijsfuncties en is momenteel hoogleraar voedingsleer en hieraan gerelateerde ziekten aan de Vrije Universiteit van Brussel.
Eric Abadie, Vice-chairman of the CPMP, b.
Eric Abadie, vice-voorzitter van het CPMP, geb.
French
14 juli 1950, Franse nationaliteit
Post-graduate qualifications in internal medicine, endocrinology, diabetology and cardiology.
Specialisaties in interne geneeskunde, endocrinologie, diabetologie en cardiologie.
He also holds an MBA.
Hij behaalde ook een MBA.
From 1981 to 1983 Dr Abadie held a number of clinical and laboratory positions, before joining the pharmaceutical industry in 1983.
Abadie een aantal klinische en laboratoriumfuncties en in 1983 ging hij naar de farmaceutische industrie.
He was director of medical affairs of the French pharmaceutical trade association from 1985 to 1993 and returned to industry until 1994.
Van 1985 tot 1993 was hij medisch directeur bij de Franse vereniging van farmaceuten; hij keerde terug naar de industrie tot 1994.
Steve Dean, Chairman of the CVMP, b.
Steve Dean, voorzitter van het CVMP, geb.
British
2 augustus 1951, Britse nationaliteit
Qualified veterinary surgeon from the Royal Veterinary College, London.
Afgestudeerd in de diergeneeskunde aan het Royal Veterinary College, Universiteit van Londen.
Mr Dean has spent periods of time in general veterinary practice, as a lecturer in anatomy and radiology at the Royal Veterinary College, London and in technical and business positions in the veterinary pharmaceutical industry.
De heer Dean was werkzaam als dierenarts en als docent anatomie en radiologie aan het Royal Veterinary College van de universiteit van Londen, en hij heeft technische en bedrijfsfuncties bekleed in de diergeneesmiddelenindustrie.
Gérard Moulin, Vice-chairman of the CVMP, b.
Gérard Moulin, vice-voorzitter van het CVMP, geb.
French
18 oktober 1958, Franse nationaliteit
PhD in Microbiology from the University of Lyon Career to date:
Gepromoveerd in de microbiologie aan de Universiteit van Lyon.
In 1984, he joined the Veterinary Medicines Laboratory in Fougères where he was assessor and rapporteur for marketing authorisation dossiers.
In 1984 ging hij naar het diergeneeskundig laboratorium in Fougères, waar hij werkzaam was als adviseur en rapporteur op het gebied van handelsvergunningen.
Since 1997 he is an active participant in the CVMP and VMRF group.
Sinds 1997 is hij lid van het CVMP en de Veterinaire Groep Vergemakkelijking van de Wederzijdse Erkenning.
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Josep Torrent i Farnell, Chairman of the COMP, b.
54/64 Josep Torrent i Farnell, voorzitter van het COMP, geb.
Qualified Pharmacist and Degree in medicine and surgery from the University of Barcelona as well as postgraduate courses in pharmacology and toxicology, public health and
Afgestudeerd als apotheker met een graad in de geneeskunde en chirurgie aan de Universiteit van Barcelona. alsmede postdoctorale cursussen farmacologie en toxicologie, volksgezondheid en Europese instellingen.
Specialist in internal medicine and clinical pharmacology.
Gespecialiseerd in interne geneeskunde en klinische farmacologie.
Doctorate pharmacology from the Autonomous University of Barcelona (UAB).
Gepromoveerd in de klinische farmacologie aan de Vrije Universiteit van Barcelona (UAB).
Torrent i Farnell worked in internal medicine and clinical pharmacology in Spain and was Assistant Professor of Pharmacology at UAB.
Torrent i Farnell was van 1977 tot 1990 werkzaam op het gebied van de interne geneeskunde en klinische farmacologie in Spanje en hij was assistent-hoogleraar farmacologie aan de UAB.
From 1990 to 1994, he was Technical Counsellor in Clinical Evaluation and Pharmacology at the Spanish Ministry of Health, Member of the CPMP Efficacy Working Party and involved in the Efficacy Group of the ICH.
Van 1990 tot 1994 was hij technisch adviseur bij de afdeling Klinische beoordeling en farmacologie van het Spaanse Ministerie van Gezondheid, lid van de werkgroep Werkzaamheid van het CPMP en betrokken bij de ICH-groep Werkzaamheid.
In 1992, he became Professor of Clinical Pharmacology and Therapeutics and Director of the Masters/ Diploma course on European Registration of Medicinal Products (UAB).
In 1992 werd hij hoogleraar klinische farmacologie en geneeskunde en directeur bij de opleiding Europese registratie van geneesmiddelen aan de UAB.
In 1998 he was coordinator Director for the creation of the Spanish Medicines Agency and Executive Director of the Spanish Medicines Agency from 1999-2000.
In 1998 was hij coördinerend directeur voor de oprichting van het Spaanse Geneesmiddelenbureau, waarvan hij vervolgens directeur werd (1999-2000).
In November 2000, he became Director-General of the Advanced Centre of Services and Training for Health and Life Sciences, Dr.
In november 2000 werd hij directeur-generaal van het Centrum voor hoger onderwijs in de bio- en gezondheidswetenschappen, Dr.
Yann Le Cam, Vice-chairman of the COMP, b.
Yann Le Cam, vice-voorzitter van het COMP, geb.
French
15 juli 1961, Franse nationaliteit
He is a graduate in business administration from the Institut Supérieur de Gestion in Paris.
Hij is afgestudeerd in bedrijfsadministratie aan het Institut Supérieur de Gestion in Parijs.
He also holds an MBA from the Centre de Perfectionnement aux Affaires, Groupe HEC-CPA, 2000, Jouy-en-Josas, France.
Hij behaalde ook een MBA in bedrijfsadministratie aan het Centre de Perfectionnement aux Affaires, Groupe HEC-CPA,2000.
Mr Le Cam has 15 years of professional experience and personal commitment in health and medical research non-governmental organisations in France, Europe and the United States in the fields of cancer, AIDS and genetic diseases.
De heer Le Cam heeft 15 jaar beroepservaring opgedaan in en zich persoonlijk ingezet voor kanker, AIDS en genetische ziekten bij NGO’ s op het gebied van gezondheid en medisch onderzoek in Frankrijk, Europa en de VS.
He served as Director-General of AIDES Fédération Nationale from 1992 to 1998.
Van 1992 tot 1998 was hij directeur-generaal van AIDES Fédération Nationale.
He later joined the French Neuromuscular Diseases Association (AFM) as Special Advisor to stimulate public health policy on rare diseases, to create the French Alliance Maladies Rares, a national umbrella organisation of 70 patients associations, and to advise the European Organisation for Rare Disorders (Eurordis), based in Paris.
Later werd hij bijzonder adviseur bij de Franse vereniging voor neuromusculaire ziekten (AFM) om het volksgezondheidsbeleid inzake zeldzame aandoeningen te bevorderen, richtte hij het Franse Alliance Maladies Rares, een nationale overkoepelende organisatie van 70 patiëntenverenigingen, op en was hij adviseur voor de Europese organisatie voor zeldzame ziekten, Eurordis, in Parijs.
He is also the Vice- Chairman of the International Alliance of Patients Organisations (IAPO) based in London.
Ook is hij vice-voorzitter van de internationale alliantie van patiëntenverenigingen (International Alliance of Patients Organisations - IAPO) in Londen.
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Unit for the Pre-authorisation evaluation of medicines for human use
55/64 Eenheid Beoordeling van geneesmiddelen voor menselijk gebruik vóór de vergunningverlening
Patrick Le Courtois, Head of Unit, b.
Patrick Le Courtois, hoofd van de eenheid, geb.
French
9 augustus 1950, Franse nationaliteit
Post-graduate degrees in tropical medicine, clinical research and epidemiology.
Specialisaties in tropische geneeskunde, klinisch onderzoek en epidemiologie.
From 1977 to 1986, Dr Le Courtois worked as a general practitioner and as director of a medical centre in Paris.
Le Courtois werkzaam als huisarts en als directeur van een medisch centrum in Parijs.
In 1986 he joined the University of Bordeaux and was involved in research areas in public health including epidemiology, clinical research, pharmacovigilance, tropical and infectious diseases, health economy and education.
In 1986 ging hij naar de Universiteit van Bordeaux. waar hij betrokken was bij onderzoek op het gebied van epidemiologie, klinisch onderzoek, geneesmiddelenbewaking, tropische en besmettelijke ziekten, gezondheidseconomie en -opleiding.
In 1990, he joined the Pharmacy Directorate of the French Ministry of Health and in 1993 the French Medicines Agency as CPMP rapporteur, Head of Unit of European Procedures and from January 1995 as a French CPMP delegate.
In 1990 werd hij aangesteld op het Franse Ministerie van Gezondheid, directoraat Farmacie; in 1993 op het Franse Geneesmiddelenbureau als CPMP-rapporteur en hoofd van de eenheid Europese procedures en vanaf januari 1995 was hij afgevaardigde van Frankrijk in het CPMP.
He joined the EMEA in September 1997 and was appointed Head of Sector for new chemical substances in June 1998 and Head of Sector for orphan drugs and scientific advice in January 2001.
In januari 2001 werd hij hoofd van de sector Wetenschappelijk advies en weesgeneesmiddelen.
Agnès Saint Raymond, Head of Sector for orphan drugs and scientific advice, b.
Agnès Saint Raymond, hoofd van de sector Wetenschappelijk advies en weesgeneesmiddelen, geb.
French
7 september 1956, Franse nationaliteit
Dr Saint Raymond held a position as paediatrician in a teaching paediatric hospital in Paris, followed by a number of years working for a number of pharmaceutical companies.
Saint Raymond werkte als kinderarts in een kinderziekenhuis met opleidingsfaciliteiten in Parijs en voorts een aantal jaren voor diverse farmaceutische ondernemingen.
In 1995 she joined the French Medicines Agency as Head of Unit for pharmaco-toxico-clinical assessment.
In 1995 trad zij in dienst van het Franse Geneesmiddelenbureau als hoofd farmaceutische, toxicologische en klinische beoordelingen.
She joined the EMEA in January 2000 and was appointed Head of Sector for Scientific Advice and Orphan Drugs in December 2001.
Zij ging naar het EMEA in januari 2000 en werd benoemd tot hoofd van de sector Wetenschappelijk advies en weesgeneesmiddelen in december 2001.
She is also in charge of issues relating to medicines used in children.
Tevens is zij belast met vraagstukken inzake geneesmiddelen voor kinderen.
John Purves, Head of Sector for quality of medicines, b.
John Purves, hoofd van de sector Kwaliteit van geneesmiddelen, geb.