natgillin/translations-raw huggingface dataset:
Titel på dokumentet Conduct of bioequivalance studies for veterinary medicinal products
Conduct of bioequivalance studies for veterinary medicinal products
EMEA/ CVMP/ 005/ 00
EMEA/CVMP/005/00 Rev 1
Testing and evaluation of the efficacy of antiparasitic substances for the treatment of tick and flea infestations in dogs and cats
Testing and evaluation of the efficacy of antiparasitic substances for the treatment of tick and flea infestations in dogs and cats
Vedtaget i februar 2001
Adopted February 2001
CVMP/ VICH/ 833/ 99
CVMP/VICH/833/99
Specific recommendations for equines
Specific recommendations for equines
CVMP/ VICH/ 834/ 99
CVMP/VICH/834/99
Specific requirements for porcines
Specific requirements for porcines
CVMP/ VICH/ 835/ 99
CVMP/VICH/835/99
Specific requirements for canines
Specific requirements for canines
Specific requirements for feline
Specific requirements for feline
Specific requirements for poultry
Specific requirements for poultry
EMEA/ CVMP/ 237/ 99
EMEA/CVMP/237/01
retningslinje for påvisning af virkningerne af nonsteroide antiinflammatoriske lægemidler
Conduct of efficacy studies for non-steroidal anti-inflammatory drugs
Vedtaget i december 2001
Adopted December 2001
EMEA/ CVMP/ 816/ 00 EMEA/ CVMP/ 237/ 99
EMEA/CVMP/816/00
Statistical principles for veterinary clinical trials Conduct of efficacy studies for non- steroidal anti- inflammatory drugs
Statistical principles for veterinary clinical trials
Vedtaget i december 2001 Sendt til høring i marts 2001
Released for consultation March 2001
EMEA/ CVMP/ 411/ 99
EMEA/CVMP/411/01
Efficacy testing of ectoparasiticides for cattle, sheep and goats
Efficacy testing of ectoparasiticides for cattle, sheep and goats
Sendt til høring i maj 2001
Released for consultation May 2001
EMEA/ CVMP/ 627/ 99
EMEA/CVMP/627/01
Revised guideline: antimikrobielle stoffer til brug i dyrlægepraksis
Antimicrobials for general veterinary use
Sendt til høring i oktober 2001
Released for consultation October 2001
EMEA/ CVMP/ 612/ 99
EMEA/CVMP/612/01
SPC for antimicrobial products
SPC for antimicrobial products
CVMP- arbejdsgruppe vedrørende immunologiske veterinærlægemidler
CVMP Immunologicals Working Party
Referencenummer EMEA/ CVMP/ 852/ 99 EMEA/ CVMP/ 743/ 00
Field trials with veterinary vaccines
Titel på dokumentet Field trials with veterinary vaccines Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products
Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products
Status Vedtaget i oktober 2001 Vedtaget i oktober 2001
Adopted October 2001
EMEA/ CVMP/ 743/ 00
EMEA/CVMP/743/00
Requirements and controls applied to bovine serum (foetal or calf) used in the protection of immunological veterinary medicinal products
Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products
Sendt til høring i februar 2001
Released for consultation February 2001
CVMP/ VICH/ 502/ 99
CVMP/VICH/095/01
Biologicals:
Biologicals:
Testing of residual formaldehyde
Testing of residual formaldehyde
Released for consultation February 2001
Released for consultation February 2001
CVMP/ VICH/ 096/ 01
CVMP/VICH/096/01
Testing of residual moisture
Testing of residual moisture
Referencenummer CVMP/ VICH/ 646/ 99
CVMP/VICH/646/01
Titel på dokumentet Pharmacovigilance of veterinary medicinal products:
Pharmacovigilance of veterinary medicinal products:
Management of periodic summary update reports (PSUs)
Management of periodic summary update reports (PSUs)
Status Sendt til høring i juli 2001
Released for consultation July 2001
CVMP/ VICH/ 647/ 99
CVMP/VICH/647/01
Pharmacovigilance of veterinary medicinal products:
Pharmacovigilance of veterinary medicinal products:
Controlled list of terms
Controlled list of terms
EMEA/ CVMP/ 695/ 99
EMEA/CVMP/695/01
Processing of renewals in the centralised procedure
Processing of renewals in the centralised procedure
CVMP- arbejdsgruppe vedrørende sikkerhed
CVMP Safety Working Party
Referencenummer EMEA/ CVMP/ 187/ 00
EMEA/CVMP/187/00
Titel på dokumentet Risk analysis approach for residues of veterinary medicinal products in food of animal origin
Risk analysis approach for residues of veterinary medicinal products in food of animal origin
EMEA/ 410/ 01
EMEA/410/01
Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products
Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products
CVMP/ VICH/ 525/ 00
CVMP/VICH/525/00
Reproduction studies
Reproduction studies
CVMP/ VICH/ 526/ 00
CVMP/VICH/526/00
Genotoxicity studies
Genotoxicity studies
EMEA/ CVMP/ 234/ 99
EMEA/CVMP/234/01
Safety evaluation of antimicrobial substances regarding the effects on human gut flora
Safety evaluation of antimicrobial substances regarding the effects on human gut flora
CVMP/ VICH/ 644/ 99
CVMP/VICH/644/01
Guidance on pre- approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance
Guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance
CVMP/ VICH/ 645/ 99
CVMP/VICH/645/01
Studies to evaluate the safety of residues of veterinary drugs in human food:
Studies to evaluate the safety of residues of veterinary drugs in human food:
Carcinogenicity testing
Carcinogenicity testing
EMEA/ CVMP/ 244/ 99
EMEA/CVMP/244/01
Pre- authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
Pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
Fælles CPMP/ CVMP- arbejdsgruppe vedrørende kvalitet
Joint CPMP/CVMP Quality Working Party
Referencenummer EMEA/ CVMP/ 598/ 99 EMEA/ CVMP/ 271/ 99
Adopted February 2001
Titel på dokumentet Process validation Limitations to the use of ethylene oxide in the manufacture of medicinal products
Limitations to the use of ethylene oxide in the manufacture of medicinal products
Status Vedtaget i februar 2001 Vedtaget i april 2001
Adopted April 2001
EMEA/ CVMP/ 453/ 99 EMEA/ CVMP/ 814/ 00 EMEA/ CVMP/ 815/ 00
Start of shelf-life of the finished dosage form
Start of shelf- life of the finished dosage form Quality of herbal medicinal products Specifications:
Quality of herbal medicinal products
Test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products
Test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products
Vedtaget i maj 2001 Vedtaget i juli 2001 Vedtaget i juli 2001
Quality of water for pharmaceutical use
EMEA/ CVMP/ 115/ 99 EMEA/ CVMP/ 115/ 99 EMEA/ CVMP/ 424/ 99
November 2001 EMEA Annual Report 2001
Quality of water for pharmaceutical use Quality of water for pharmaceutical use In- use stability testing of veterinary medicinal products
Quality of water for pharmaceutical use
Vedtaget i november 2001 Sendt til høring i februar 2001 Sendt til høring i maj 2001
Released for consultation February 2001
EMEA/ CVMP/ 961/ 99
EMEA/CVMP/961/01
Use of near infra- red spectroscopy by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorisation
Use of near infra-red spectroscopy by the pharmaceutical industry and the data to be forwarded in part II of the dossier for a marketing authorisation
Udvalget for Lægemidler til Sjældne Sygdomme
Committee for Orphan Medicinal Products
Referencenummer EMEA/ 14220/ 00- DA
Reference number
Titel på dokumentet Procedure for orphan medicinal product designation – general principles
Procedure for orphan medicinal product designation - general principles
Status Revideret i januar 2001
Revised January 2001
EMEA/ 2677/ 01
EMEA/2677/01
Procedure for a sponsor to appeal a negative COMP opinion
Procedure for a sponsor to appeal a negative COMP opinion
Færdiggjort i februar 2001
Finalised February 2001
EMEA/ 189/ 01
EMEA/189/01
Guideline on the format and content of annual reports
Guideline on the format and content of annual reports
Sendt til høring i september 2001
Released for consultation September 2001
EMEA/ 436/ 01 Bilag 11
EMEA/436/01
Points to consider on the calculation and reporting of prevalence of a condition for orphan designation
Points to consider on the calculation and reporting of prevalence of a condition for orphan designation
EMEA' s kontaktpunkter
68 EMEA Annual Report 2001
Lægemiddelovervågning og indberetning af produktionsfejl
Annex 11 EMEA contact points
Spørgsmål om lægemiddelovervågning af humanmedicinske lægemidler
Pharmacovigilance and product defect reporting
(direkte nummer) (44- 20) 74 18 85 92 E- mail: noel. wathion@ emea. eu. int
Documentation services A wide range of documents has now been published by the
Spørgsmål om lægemiddelovervågning af veterinærlægemidler
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.
(direkte nummer) (44- 20) 74 18 85 81 E- mail: barbara. freischem@ emea. eu. int
The EMEA receives safety reports from within the EU and outside concerning centrally authorised medicinal products and coordinates action relating to the safety and quality of medicinal products.
Spørgsmål om produktionsfejl og andre kvalitetsrelaterede spørgsmål
EMEA, including press releases, general information documents, annual reports and work programmes.
Francisco PEÑARANDA FERNANDEZ Faxnr. vedrørende produktionsfejl i tilfælde af hurtig varsling (44- 20) 74 18 85 90 E- mail: francisco. penaranda@ emea. eu. int
These and other documents are available either on the Internet at http://www.emea.eu.int or by writing to:
EMEA udsteder certifikater for lægemidler i overensstemmelse med Verdenssundhedsorganisationens bestemmelser.
Subscription Service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus
Forespørgsler om certifikater for human - eller veterinærmedicinske lægemidler, der er godkendt via den centraliserede procedure
For matters relating to pharmacovigilance for medicinal products for human use:
Jonna SUNELL- HUET Tlf.:
Canary Wharf UK - London E14 4HB
Disse og andre dokumenter findes på internettet på følgende adresse: http: // www. emea. eu. int eller kan rekvireres ved skriftlig henvendelse til:
Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel.wathion@emea.eu.int
Subscription Service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf UK - London E14 4HB Der kan abonneres på alle EMEA' s offentliggjorte dokumenter, enten i elektronisk udgave eller i papirformat.
Further information can be obtained from the above address
Yderligere oplysninger kan fås ved henvendelse til ovennævnte adresse eller til
For matters relating to pharmacovigilance for medicinal products for veterinary use:
Iro MAVROPOULOS Tlf.:
Iro MAVROPOULOS
(direkte nummer) (44- 20) 74 18 85 82 E- mail: subscriptions@ emea. eu. int
Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara.freischem@emea.eu.int For product defect and other quality-related matters:
Anmodninger om mapper med generelt informationsmateriale sendes til
Direct telephone (44-20) 74 18 85 82 E-mail: subscriptions@emea.eu.int Requests for general information packs should be sent to:
Amanda BOSWORTH Tlf.:
Amanda BOSWORTH
(direkte nummer) (44- 20) 74 18 84 08 E- mail: amanda. bosworth@ emea. eu. int
(44-20) 74 18 85 90 E-mail: francisco.penaranda@emea.eu.int
Lister over europæiske eksperter
Direct telephone (44-20) 74 18 84 08 E-mail: amanda.bosworth@emea.eu.int European experts lists
Listerne over europæiske eksperter kan efter anmodning besigtiges i EMEA.
The list of European experts is available for examination on
Skriftlige anmodninger kan sendes til EMEA eller til følgende e- mail- adresser:
Certificates of a medicinal product The EMEA issues certificates of a medicinal product in
Listen over humanmedicinske eksperter
request at the EMEA offices.
human_ experts@ emea. eu. int
conformity with the arrangements laid down by the World Health Organisation.
Listen over veterinærmedicinske eksperter
Human medicines’ experts list: human_experts@emea.eu.int Veterinary medicines’ experts list: vet_experts@emea.eu.int
vet_ experts@ emea. eu. int
and are intended for use in support of marketing authorisation applications in and export to non-EU countries.
Listen over tilsynsførende eksperter
Inspectors’ experts list: inspectors_experts@emea.eu.int
inspectors_ experts@ emea. eu. int
For enquiries concerning certificates for centrally authorised medicines for human or veterinary use
Pressekontor
Press officer
Pressesekretær
Jonna SUNELL-HUET Direct telephone (44-20) 74 18 84 65 E-mail: certificate@emea.eu.int
(direkte nummer) (44- 20) 74 18 84 27 E- mail: martin. harvey@ emea. eu. int
Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin.harvey@emea.eu.int
Ottende Årsberetning 2002
Eighth Annual Report 2002
Vedtaget af bestyrelsen den 19. december 2002 The European Agency for the Evaluation of Medicinal Products
(44-20) 74 18 84 00 Fax:
EMEA/ MB/ 055/ 02/ da/ Endelig udg.
Reproduction is authorised provided the source is acknowledged.
Ottende årsberetning om aktiviteterne i Det Europæiske Agentur for Lægemiddelvurdering 2002
EMEA Annual Report 2002
Vedtaget af bestyrelsen den 19. december 2002
Foreword by the Chairman of the Management Board Introduction by the Executive Director
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Chapter 4 Inspections 4.1 Coordination of inspections for centralised
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int EMEA 2003 Reproduction and/ or distribution of this document is authorised for non- commercial purposes only provided the EMEA is acknowledged Indholdsfortegnelse
procedures 4.2 Implementation of the clinical trials directive
FORORD VED BESTYRELSESFORMANDEN................................................................................................................
National competent authorities
INDLEDNING VED DEN ADMINISTRERENDE DIREKTØR............................................................................................
1.3 Review of the European marketing authorisation
EMEA’ S ORGANISATIONSPLAN..............................................................................................................................
Revision of EMEA fees Transparency Interested parties International partners Quality management
8
7 7 7 8 8
KAPITEL 1 EMEA I DET EUROPÆISKE SYSTEM......................................................................................................
5.1 Implementation of the EU telematics strategy 5.2 Project management 5.3 Meeting management and conferences 5.4 Document management and publishing
1. 1 1. 2
37
Bestyrelsen Kompetente nationale myndigheder
1.10 Financial control
9 9
9
1. 3 1. 4 1. 5 1. 6 1. 7 1. 8
Personnel and budget Infrastructure services
Revision af det europæiske system for markedsføringstilladelser Revision af EMEA' s gebyrer Gennemsigtighed De interesserede parter Internationale partnere Kvalitetsstyring
Chapter 2 Medicines for Human Use 2.1 Initial evaluation
10 10 10 11 11 12
10 11
1. 9 European Department for the Quality of Medicines (Det Europæiske Direktorat for
6.3
Lægemiddelkvalitet) 1. 10 Finanskontrol
Accounting
12 13
38
KAPITEL 2 HUMANMEDICINSKE LÆGEMIDLER.....................................................................................................
Post-authorisation activities Pharmacovigilance and maintenance activities Scientific advice and protocol assistance
14
13 14 15
2. 1 2. 2 2. 3 2. 4 2. 5 2. 6 2. 7 2. 8 2. 9
Annexes 1 Members of the Management Board 2 Members of the Committee for Proprietary
Indledende evaluering Aktiviteter efter godkendelse Lægemiddelovervågning og ajourføringsaktiviteter Videnskabelig rådgivning og protokolbistand Voldgifter og henvisninger af sager til Fællesskabet Paralleldistribution Lægemidler til sjældne sygdomme Arbejdsgrupper og ad hoc- grupper Internationale aktiviteter
Arbitration and Community referrals
16 18 19 21 23 25 25 29 32
16
2. 10 Gruppen for fremme af gensidig anerkendelse
Parallel distribution
32
17
35
3 Members of the Committee for Veterinary Medicinal Products
3. 1 3. 2 3. 3 3. 4 3. 5 3. 6 3. 7 3. 8
43
Indledende evaluering Fastsættelse af maksimalgrænseværdier for gamle stoffer Aktiviteter efter godkendelse Lægemiddelovervågning og ajourføringsaktiviteter Videnskabelig rådgivning Voldgifter og henvisninger af sager til Fællesskabet Arbejdsgrupper og ad hoc- grupper Den veterinærmedicinske gruppe for fremme af gensidig anerkendelse
2.7
37 38 39 40 41 41 41 43
Orphan medicinal products
EMEA’ s årsberetning for 2002 EMEA/ MB/ 055/ 02/ da/ Endelig udg.
18
KAPITEL 4 INSPEKTIONERSEKTIONSLEDER..........................................................................................................
4 Members of the Committee for Orphan
4. 1 4. 2 4. 3 4. 4 4. 5
International activities
Koordinering af inspektionerne i forbindelse med de centraliserede procedurer Gennemførelse af direktivet om kliniske forsøg Gensidige anerkendelsesaftaler Certificering af lægemidler Stikprøvekontrol og afprøvning
5 National competent authority partners
45 46 47 48 48
45
KAPITEL 5 KOMMUNIKATION OG NETVÆRKSSAMARBEJDE.................................................................................
EMEA budget summaries 2001-2003 CPMP opinions in 2002 on medicinal products for human use CVMP opinions in 2002 on medicinal products
49
49 50
Gennemførelse af EU’ s telematikstrategi Projektstyring Mødestyring og konferencer Styring og offentliggørelse af dokumenter
3.2 Establishment of maximum residue limits for old substances
49 50 51 52
26
53
9
Personale og budget Infrastrukturtjenester Bogholderi
for veterinary use COMP opinions in 2002 on designation of
53 54 55
54
56
27
Bilag 1 Medlemmer af bestyrelsen Bilag 2 Medlemmer af Udvalget for Farmaceutiske Specialiteter Bilag 3 Medlemmer af Udvalget for Veterinærlægemidler Bilag 4 Medlemmer af Udvalget for Lægemidler til Sjældne Sygdomme Bilag 5 Partnere fra de kompetente nationale myndigheder Bilag 6 Sammendrag af EMEA' s budgetter for 2001 - 2003 Bilag 7 CPMP- udtalelser i 2002 om humanmedicinske lægemidler Bilag 8 CVMP- udtalelser i 2002 om veterinærlægemidler Bilag 9 COMP- udtalelser i 2002 om udpegelse af lægemidler til sjældne sygdomme Bilag 10 Retningslinjer og arbejdsdokumenter i 2002 Bilag 11 Oversigt over voldgifter og henvisninger af sager til Fællesskabet i 2002 Bilag 12 EMEA' s kontaktpunkter
orphan medicinal products
57 58 59 60 61 65 67 71 74 78 84 86
57
EMEA’ s årsberetning for 2002 EMEA/ MB/ 055/ 02/ da/ Endelig udg.
3.4 Pharmacovigilance and maintenance activities 3.5 Scientific advice
2309/ 93.
27 28
EMEA 2003 Side 3/ 88
10 11
EMEA- ansattes e- mail- adresser er opbygget således:
Guidelines and working documents in 2002 Arbitration and Community referrals overview 2002 71
fornavn. efternavn@ emea. eu. int
62
E- mail- adresseformatet ‘ @ emea. eudra. org ’ blev taget ud af drift den 1. oktober 2002, og meddelelser sendt til denne adresse når ikke længere frem.
3.6 Arbitration and Community referrals 3.7 Working parties and ad hoc groups 3.8 Veterinary mutual recognition facilitation group 2 EMEA Annual Report 2002
EMEA’ s årsberetning for 2002 EMEA/ MB/ 055/ 02/ da/ Endelig udg.
28 29 30
EMEA' s idégrundlag
12
EMEA 2003 Side 4/ 88
EMEA contact points
At bidrage til at
72
beskytte og styrke folkesundheden og dyrs sundhed ved:
EMEA mission statement
Det europæiske system består af to metoder til godkendelse af lægemidler.
The European system offers two routes for authorisation of medicinal products.
EMEA spiller en rolle i begge procedurer:
The EMEA plays a role in both procedures:
- Den centraliserede procedure er obligatorisk for bioteknologisk fremstillede lægemidler og kan
To contribute to the protection and promotion of public and animal health by: • Mobilising scientific resources from throughout the European Union to provide high quality evaluation of medicinal products, to advise on research and development programmes and to provide useful and clear information to users and health professionals
anvendes for andre innovative produkter efter virksomhedens anmodning.
products derived from biotechnology and available at the request of companies for other innovative new products.
Ved afslutning af den faglige vurdering, der foretages af agenturet senest 210 dage efter modtagelse af ansøgningen, fremsendes det videnskabelige udvalgs udtalelse til Europa - Kommissionen, hvor den omdannes til en enkelt tilladelse med gyldighed i hele Den Europæiske Union.
At the conclusion of the scientific evaluation, undertaken in 210 days within the Agency, the opinion of the scientific committee is transmitted to the European Commission to be transformed into a single market authorisation applying to the whole European Union.
- Den decentraliserede procedure (eller gensidige anerkendelsesprocedure) gælder for størsteparten
It provides for the extension of marketing authorisations granted by one
af de traditionelle lægemidler og er baseret på princippet om gensidig anerkendelse af nationale godkendelser.
• Controlling the safety of medicines for humans and animals, in particular through a pharmacovigilance network and the establishment of safe limits for residues in food-producing animals
EMEA’ s årsberetning for 2002 EMEA/ MB/ 055/ 02/ da/ Endelig udg.
EMEA Annual Report 2002
EMEA 2003 Side 5/ 88
3
Lægemiddelkontrol af såvel human - som veterinærmedicinske lægemidler udgør et vigtigt bidrag til det høje offentlige sundhedsniveau, som borgerne i Den Europæiske Union nyder godt af, og agenturet spiller en central rolle i bevarelsen af dette høje niveau.
Foreword by the Chairman of the Management Board Keith Jones Medicines control in both human and veterinary medicine is an important contributor to the high standards of public health enjoyed by citizens of the European Union and this Agency plays a major role in maintaining those high standards.
Dette opnås ved at godkende nye innovative lægemidler, ved at undersøge disse lægemidlers sikkerhed under normale anvendelsesforhold og ved at sikre, at der træffes passende foranstaltninger, når det er nødvendigt for at bevare dette høje niveau.
It achieves this through the licensing of innovative new medicines, by examining their safety under normal conditions of use and by ensuring that appropriate action is taken when necessary to maintain those standards.
Denne rolle på folkesundhedsområdet er blevet varetaget på en velgennemført og fyldestgørende måde i 2002, hvilket fremgår af de nærmere enkeltheder i indholdet af denne beretning.
The way in which this public health role has been fully and well executed during 2002 is described in detail in the substance of this report.
Beretningen viser agenturets resultater i forhold til den godkendte plan for det foregående år og er et godt vidnesbyrd om, at serviceniveauet for aktørerne (patienter, fagfolk inden for sundhedssektoren, de europæiske institutioner, medlemsstaterne og lægemiddelindustrien) er blevet bevaret på et højt plan og på visse måder endog forbedret.
The challenges of the future will be numerous, including implementation of the review of the licensing procedures, the implications of enlargement, information management for the community system of medicines control, the clinical trials and pharmacovigilance support systems and further extension of transparency for the operations of the Agency.
Den høje kvalitet af arbejde og beslutningstagning er blevet opnået via hårdt arbejde fra alle de berørtes side, navnlig Fællesskabets eksperter, som arbejder via den videnskabelige udvalgsstruktur.
The board considers that the Agency is in a sound position to take on these challenges.