natgillin/translations-raw huggingface dataset:
όκιλλαγ εσ ςογόλονιρκοδνε ήκινιλκ ςω εκηθσάγρε
He is also the Vice-Chairman of the International Alliance of Patients Organisations (IAPO) based in London.
οτ ςωΈ αρε ήσ ιρχέ αί ορδοιδατΣ 1987
Mr Le Cam has three daughters, the eldest of whom is affected by cystic fibrosis.
νητσ ατητόκιδιε ε αίλλαΓ
Unit for the Pre-Authorisation Evaluation of Medicines for Human Use
ςατητόοκηπυ ςήκιλλαγ
Patrick Le Courtois, Head of Unit, b.
υοίτραΜ ςιτσ ασίεθηννεγ νωκά ραφ 1958, 9
9 August 1950, n.
Isabelle Moulon,
French Education:
υοτ οιράυοναΙ νοΤ ατνόϊορπ άκιγολοιβ ατ ιακ αίγολονχετοιβ ητ αιγ αέ οτ υοτ ςονε άτσϊορπ
PhD in public health from the University of Bordeaux.
α ητσάιδ οτΣ αίναχη οιβ 1974- 1996,
Post- graduate degrees in tropical medicine, clinical research and epidemiology.
ήκιτυεκα ραφ ητσ εκητσάγρε
John Purves, Head of Sector for quality of medicines, b.
οτ ςωέ
22 April 1945, n.
Purves
British Education:
οτ όπΑ αρε ήσ ιρχέ αί ορδοιδατΣ
Qualified as a pharmacist from Heriot-Watt University, Edinburgh.
:
Career to date:
1972
From 1972 to 1974,
1945, υοίλιρπΑ
Career to date:
22 ςιτσ ςίεθηννεγ νωκά ραφ νωτ ατητόιοπ νητ αιγ αέ οτ ςονε άτσϊορΠ
From 1977 to 1986, Dr Le Courtois worked as a Dr Purves worked in the pharmaceutical industry.
νώλυοβ υσ νώκινο ητσιπε ήχοραπ νητ
Between 1974 general practitioner and as director of a medical centre in Paris.
άναφρο ατ αιγ αέ οτ υονέ ατσϊορπ ηέρχ νώλετκΕ υοτ οιτράΜ νοτ ςαδάνο ςονε άτσϊορπ εκητσίροι∆ νώλυοβ υσ νώκινο ητσιπε
In and 1996, he held posts in the UK Medicines Division and the 1986 he joined the University of Bordeaux and was involved in Medicines Control Agency, including inspector of pharmaceutical research areas in public health including epidemiology, clinical manufacture, reviewer of dossiers and manager of the research, pharmacovigilance, tropical and infectious diseases, Biotechnology and Biological Unit.
Patrick Le Courtois,
He was the UK representative health economy and education.
2001. ήχοραπ νητ ιακ ακα ράφ άναφρο ατ αιγ αέ οτ υοτ υονέ ατσϊορπ ηέρχ ίελετκε υοτ
In 1990, he joined the Pharmacy at the Biotechnology Working Party, involved in the generation of Directorate of the French Ministry of Health and in 1993 the many guidelines relating to biotechnology and biological products.
οιράυοναΙ νοτ όπΑ νώισυο νώκι ηχ νωέν αέ οτ υοτ ςονε άτσϊορπ εκητσίροιδ
French Medicines Agency as CPMP rapporteur, Head of Unit of He joined the EMEA in August 1996 as Head of Sector for European Procedures and from January 1995 as a French CPMP biotechnology and biologicals.
υοτ οινύοΙ νοτ
He was appointed Head of Sector delegate.
1997
He joined the EMEA in September 1997 and was for quality of medicines in January 2001. appointed Head of Sector for new chemical substances in June 1998 and Head of Sector for orphan drugs and scientific advice in January 2001.
ητσ ςαίεπωσορπιτνα ςήκιλλαγ ςητ CPMP.
He was appointed Head of Unit March 2001.
υοτ οιράυοναΙ νοτ όπα ιακ νώισακιδαιδ νώκϊαπωρυε νωτ ςαδάνο ςητ ςονε άτσϊορπ 1995, ςητ ςήτηγησιε ςω νωκά ραΦ ό σιναγρΟ όκιλλαΓ νοτσ
Marisa Papaluca Amati, Deputy Head of Sector for safety and efficacy of medicines,
CPMP, οτ όπα ιακ ςαίλλαΓ
Patrick Le Courtois, Acting Head of Sector for orphan drugs and scientific advice
1993
b.
ςητ ςαίεγΥ υοίεγρυοπΥ υοτ ςήκιτυεκα ραΦ ησνυθύει∆ ητσ εκηθσάγρε
Degree in medicine and surgery from the University of Rome.
οτ όπΑ ςησυεδίαπκε
Isabelle Moulon, Head of Sector
εχίετε υσ ιακ ώτνροπΜ υοτ οι
Post-
ήτσιπεναΠ οτσ εκηθσάγρε
for safety and efficacy of
ςήτνυθυειδ ιακ ςήκιρται ςήκινεγ ςόρται
graduate studies in cardiology and
οτ ςωέ
medicines,
ςατητόοκηπυ ςήκιλλαγ
endocrinology.
:
b.
9
9 March 1958, n.
αδίλεΣ
French
όκιλεΤ
Career to date:
ςαίσαγρε α αργόρΠ 2001- 2002
From 1978 to 1983 Dr Papaluca worked as a
2001
Education:
υοτ οιρβώτκΟ
Qualified medical doctor
ςητ ΙΙ ιακ Ι ςαίσαγρε
research fellow in the State University of Rome on projects in
νωδά ο νώνθειδ νωτ ςολέ ιακ
from the University of Grenoble, France.
νώκιρται αιρτνύθυειδ ςω εκητσάγρε
the area of clinical immunology, oncology and cellular
οτ ςωέ1984 οτ όπΑ ςαίγολοσονα ςήκιραττυκ ςητ ιακ.
Specialist in endocrinology.
1983
Post-
οτ ςωέ1978
immunology.
οτ όπΑ αρε ήσ ιρχέ αί ορδοιδατΣ:
From 1984 to 1994, as medical director of the
ςατητόοκηπυ
graduate studies in statistics,
υοίρβωτκΟ ςιτσ ασίεθηννεγ νωκά ραφ νωτ 1954, 12
Pharmaceutical Department of the Italian Ministry of Health,
ατητόκιτα σελετοπα,
methodology and nutrition.
νητ ιακ αιελάφσα νητ αιγ αέ οτ ηνέ ατσϊορπ αιρτώρηλπανΑ
she was in charge of the Operative Centre for Community Procedures and was an Italian member of the former
υοπό ςηννέιΒ ςητ υοί ητσιπεναΠ υοτ ςαίγολοκιξοΤ ιακ ςαίγολοκα ραΦ α ή Τ οτσ αιρτήγηθακ,
Worked as a clinical endocrinologist in a French hospital until 1987 and then joined the Directorate of Pharmacy at the French Ministry of Health.
1992,
She worked for the pharmaceutical industry from 1992 to 1995 before joining the EMEA in July 1995.
υοτσύογυΑ ςιτσ ασίεθηννεγ ςαιεδά ςησηγήροχ
She was appointed Head of Sector for safety and efficacy of medicines in January 2001.
Sabine Brosch, ησέθ ήνεΚ
Committee for Proprietary Medicinal Products.
ςησηγήροχ ςητ ιατεπέ υοπ νωτνόϊορπ νώκιτυεκα ραφ νωτ ατητόκιτα σελετοπα ιακ αιελάφσα νητ ιακ ησηνπύργαπεοκα ραφ νητ αιγ αέ οτ ςονε άτσϊορΠ
Dr Papaluca has acted as EU rapporteur for an ICH efficacy topic and as a member of the International CIOMS Working Groups I and II on pharmacovigilance.
υοτ οιράυοναΙ
She joined the EMEA in October 1994.
υοτ οιάΜ οτ όπα ΑΕΜΕ νοτσ ιατεζάγρΕ ςίε οτ ςύοκιτυεπαρεθ ςύολλοπ εσ ςησιρώχατακ 1996.
She was appointed Deputy Head of Sector for safety and efficacy of medicines in January 2001.
νωεσήτια
EMEA Work Programme 2001-2002 41
νώνθειδ ςάριεσ ήλοβοπυ νητ ιακ ηξατνύσ ητ αιγ ςονυθύεπυ νατή υοπό
Unit for the Post-Authorisation Evaluation of Medicines for Human Use
Research Limited
11 September 1956, n.
Glaxo Group
Belgian Education:
ςητ νωτά εθ νώκιτσι θυρ νώνθειδ α ή τ οτσ εκηθσάγρε
Qualified pharmacist from the Free University of Brussels.
οτ όπΑ ςηξυτπάνα ιακ
Career to date:
υονίλβυο∆ υοτ
Mr Wathion first worked as pharmacist in a retail pharmacy.
οτ όπα αλυοψάκορκι εσ ύο σιβωλκγε υοτ αέ οτ Trinity College
He was later appointed to the Pharmaceutical Inspectorate (Ministry of Social Affairs and Public Health) in Brussels as a Chief Inspector, acting as the
ιακ - BSc Pharm - ςήκιτυεκα ραφ οίχυτΠ ησυεδίαπκΕ master
Tony Humphreys, Head of Sector for regulatory affairs and organisational support, b.
12
12 December 1961, n.
ςήκιτωναγρο ιακ νωεσέθοπυ
Irish Education:
νώκιτσι θυρ αέ οτ ςονε άτσϊορΠ ςαδάνο ςονε άτσϊορπ εκητσίροιδ
Qualified as a pharmacist, BSc (Pharm) and was granted a Masters degree in pharmaceutics in the research area of microencapsulation from Trinity College Dublin.
υοτ οιρβ έτπεΣ νοτ ιακ
Secretary of the Belgian Medicines Commission.
ςησηνπύργαπεοκα ραφ ιακ νωεσέθοπυ νώκιτσι θυρ αέ οτ υοτ ςονε άτσϊορπ ςω
He is a former Belgian Member of both the CPMP and CVMP, and representative on the Pharmaceutical Committee, Standing Committee and Notice to Applicants working group.
1996
He joined the EMEA in August 1996 as Head of Sector for regulatory affairs and pharmacovigilance and was appointed Head of Unit in September 2000.
ήπορτιπΕ
Career to date:
ςητ αέτα αρΓ ηέρχ ςατνώλετκε ςήτηρωεθιπΕ ςορετώνΑ ςω ςελλέξυρΒ ςιτσ ςαίεγΥ ςαισό η∆
Since qualifying in 1983 Mr Humphreys has worked in the area of development pharmaceutics for a national branded generics manufacturer and an international research and development company.
ςαιεδά ςησηγήροχ ςητ ιατεπέ υοπ ησήρχ ηνιπώρθνα αιγ νωτνόϊορπ νώκιτυεκα ραφ ησηγόλοιξα νητ αιγ αδάνοΜ 62/ 65
In 1991 he joined the International Regulatory Affairs Division of Glaxo Group Research Limited where he was responsible for the development and submission of a series of international registration applications in a number of therapeutic areas.
1996.
He joined the EMEA in May 1996 and was appointed Head of Sector for regulatory affairs and operational
ιακ ςησνα ήσ ιακ ςηση όνιξατ α αργόρπ όκϊαπωρυΕ οτ ε οίεγρυοπΥ οτσ αίνα ρεΓ ητσ εψερτσέπε ιακ
He ad of Sector for pharmacovigilance, post-
εκηθήλοχσΑ
support in January 2001.
οτ ςοτνολλάβιρεΠ
Austrian
1995.
Education:
οτ ήπορτιπΕ ήκϊαπωρυΕ
Post-graduate studies in pharmacology at the University of Melbourne and Auckland.
νητσ ηθσάπσεπΑ 1992
In 1992 she moved to the Pharmacovigilance Department at the Austrian Ministry of Health and completed a 6-month regulatory traineeship in the Pharmaceuticals Unit of the European Commission in 1995.
1996
She joined the EMEA in November 1996 and was appointed Deputy Head of Sector for pharmacovigilance, post-authorisation safety and efficacy of medicines in January 2001.
οΤ νωεσίρωχατακ
42 EMEA Work Programme 2001-2002
νητσ εκητσάγρε
Unit for Veterinary Medicines and Information Technology
: οτ ςωέ 1987 οτ όπΑ
Peter Jones, Head of Unit, b.
Ashley- Smith
9 August 1947, n.
υονίδνοΛ υοτ οι ήτσιπεναΠ
British Education:
υοτ ςήκιγρυοριεχ ςήκιρταινητκ
Graduated in veterinary medicine from the Faculty of Veterinary Science at
Royal Veterinary College, οίχυτΠ υονίδνοΛ υοτ οι ήτσιπεναΠ
Jill Ashley-Smith, Head of Sector for veterinary marketing authorisation procedures, b.
18
18 December 1962, n.
,
British
Jill Ashley- Smith,
Liverpool University and is a Member of the
VICH.
Education:
νακηθέτανα υοτ
Graduated in pharmacology
υοτ οινύοΙ νοτ όπα
Royal College of Veterinary Surgeons of the
οτσ ιατεζάγρΕ ΑΠΗ οτσ
from Kings College, London University.
New Jersey,
United Kingdom.
ςητ νωτνόϊορπ νώκιρταινητκ Merck Sharp and Dohme
Qualified as a veterinary surgeon from the Royal Veterinary College, London
ςήκινατερβ
Career to date:
υοτσύογυΑ ςιτσ ςίεθηννεγ ςαδάνο ςονε άτσϊορΠ 9,
After several years in general veterinary practice in the United Kingdom and Canada, Dr Jones joined the
Peter Jones,
University.
νώιροφορηλπ ςαίγολονχετ ιακ νωτνόϊορπ νώκιτυεκα ραφ νώκιρταινητκ αδάνοΜ 63/ 65
pharmaceutical industry in the animal health sector.
αδίλεΣ
He has held a
1987 ςονυθύεπυ εσελέτειδ υοπό Telecom Eireann νητσ εκηθσάγρΕ αρε ήσ ιρχέ αί ορδοιδατΣ: υονίλβυο∆ υοτ
From 1987 to 1994, Dr Ashley-Smith was
οτ όπα ςόκιναχη ςογόλορτκελη ςω
number of appointments in research and regulatory affairs in
MScιακ ήκισυφ ήκιτα αριεπ νητσ α ωλπί∆ ησυεδίαπκΕ
employed in the veterinary pharmaceutical industry, first as a
ςατητόοκηπυ ςήκιδναλρι
multinational companies and, most recently, as Senior Director of
υοίρβ εκε∆ ςιτσ ςίεθηννεγ 1957,
technical adviser and subsequently as a registration manager.
4
In
υοτ οιλίρπΑ νοτ όπα ΑΕΜΕ νοτ αιγ ιατεζάγρΕ αδάλλΕ
International Regulatory Affairs for Animal Health Products for Merck
νητσ νώιροφορηλΠ νωτ ςαίγολονχεΤ
1994, she joined the UK Veterinary Medicines Directorate as
ςησηρόφορηλΠ νωτά ητσυΣ ςήτνυθυει∆ /
Sharp and Dohme in New Jersey, USA.
ενιγέ 1992. οΤ 1993 οτ ςωέ
He joined the EMEA in June
οτ όπα ςολυοβ ύσ ςορετώνα ςω εκηθσάγρε ιακ νωίδεχσ ςονυθύεπυ
senior veterinary assessor in the pharmaceuticals and feed
ιακ νωτά ητσυσ ςήτυλανα ςήτσιτα αργορπ ςω νώιροφορηλπ νωτ ςαίγολονχετ ςητ αέ οτ νοτσ, ςιεσέθ ςεροφάιδ εχίετακ ςηκάδιρυοΖ κ ο
1995, and was appointed Head of the Veterinary Unit in December of
οτ ςωέ1985
additives team.
οτ όπΑ αρε ήσ:
She participated as UK CVMP member from
ιρχέ αί ορδοιδατΣ υοτ οι ήτσιπεναΠ οτσ
the same year and took on responsibility for information technology in
BSc ςολτίτ ιακ ήκιροφορηλπ νητσ
1996 until joining the EMEA in July 1997.
MSc
He is EU coordinator in the VICH.
ςατητόοκηπυ ςήκιδηυοσ
Kornelia Grein, Head of Sector for safety of veterinary medicines, b.
υοίραυορβεΦ
24 July 1952, n.
ςιτσ 1958,
German Education:
8
8 February 1958, n.
ςίεθηννεγ νώιροφορηλπ νωτ ςαίγολονχετ αέ οτ ςονε άτσϊορΠ ςηκάδιρυοΖ λήαχιΜ
PhD in organic chemistry from the Free University of Berlin.
αδίλεΣ
Education:
ςαίσαγρε α αργόρΠ 2001- 2002
In 1987 she joined the German Environmental Agency as scientific administrator.
EMEA/ MB/ 003/ 01- EL - ήπορτιπΕ ήκϊαπωρυΕ νητσ ςαίε ηχ ςητ αέ οτ νοτσ
Seconded to the European Commission in 1992, she returned to Germany to the Ministry for Environment in 1995.
ςοτα άργορπ υοτ ςιεσάρδ ςιτ αιγ
She was involved in the EU classification and labelling scheme and risk assessment of chemical substances, as well as in the harmonisation activities on these topics both within the EU and OECD.
ςαέτα αργ ςόκινο ητσιπε ςω εκητσάγρε
She joined the EMEA in April 1996.
οτ ςωέ
Gothenburg.
οτ όπΑ
Career to date:
1993
In 1993 he became Director of Information Systems/Information Technology at Astra AB in Greece.
υοτ οι ήτσιπεναΠ
He joined the EMEA in April 1998.
Bénéfice
David Drakeford, Deputy Head of Sector for information technology, b.
Μ αίε ηχ
4 December 1957, n.
Sylvie Bénéfice,
Irish Education:
υοτ οιλίρπΑ νοτ όπα ΑΕΜΕ νοτ αιγ ιατεζάγρε αν εσιχρά
Honours degree in experimental physics, and MSc in electronic engineering from Trinity College Dublin.
κ Η αίγηβροΝ ητσ ςήπορτιπΕ
national data communication network.
ςήκϊαπωρυΕ ςητ ςαίεπωσορπιτνΑ ςητ ςησωίρη κεΤ ςαίσερηπΥ ςητ αίγρυοτιελ ιακ ησατσάτακγε
In 1987, he joined Coopers & Lybrand where he was a senior management consultant specialising in the management and financial control of large, primarily IT-related, projects.
ςητ οι ήτσιπεναΠ οτσ νώιροφορηλπ νωτ αίγολονχετ νητ ιακ αί ονοκηθοιλβιβ ητσ άκαιχυτπατε
He was also involved in numerous multinational project management and business analysis assignments, including managing the implementation of a worldwide information management system for clinical trials on
East Anglia
Career to date:
ςατητόοκηπυ ςήκιναδ
David Drakeford worked with
υοίρβωτκΟ ςιτσ ασίεθηννεγ
behalf of a Swiss-based pharmaceutical company.
οτ ςωέ
He joined the
οτ όπΑ ςήγωγαραπ ςείγρυοτιελ 1980
Telecom Eireann where he managed the implementation of a
εσ ιακ 1973
EMEA in February 1997.
Fairchild οτ όπΑ αρε ήσ ιρχέ αί ορδοιδατΣ
EMEA Work Programme 2001-2002
:
43
Assurance.
Technical Coordination Unit
Institute of Quality
Karel de Neef, Head of Unit, b.
ςητ ςολέΜ
21 December 1946, n.
1943,
Dutch Education:
υοίνυοΙ
Qualified medical doctor from
19
19 June 1943, n.
ςιτσ ςίεθηννεγ νωεσήρωεθιπε αέ οτ ςονε άτσϊορΠ, υοτ οιτράΜ οτ όπα ΑΕΜΕ νοτ αιγ ιατεζάγρΕ ΑΠΗ
Post-graduate work in cardiology and epidemiology at Erasmus
Stephen Fairchild,
Education:
ςιτσ
University, Rotterdam.
1996.
Career to date:
Hoffmann la Roche
Career to date:
νητσ νωνέ οδεδ νώκινιλκ ςησιρίεχαιδ ςητ ςήτνυθυειδ ςήνθειδ ενιγέ
In 1976 he joined Organon International in the Netherlands, holding posts in neurophysiology, clinical research and clinical information management.
1992
In 1992 he became International Director of clinical data management with Hoffmann-La Roche based the USA.
,
He
υοτ οι ήτσιπεναΠ.
systems and in production operations.
1973,
Between 1973 and 1980 he was employed as a medicines inspector in the UK Department of Health.
ήκιτσιτατσοιβ νώιροφορηλπ ησιρίεχαιδ νωκά ραφ νώκινιλκ ςηξιλέξε ςητ αέ οτ
He rejoined industry working for French and British multi-national pharmaceutical companies in international quality assurance before joining the EMEA in August 1995.
υοτ
joined the EMEA in March 1996.
21 ςιτσ ςίεθηννεγ ςαδάνοΜ ςονε άτσϊορΠ
Beatrice Fayl, Head of Sector for document management and publishing, b.
Karel de Neef,
9 October 1959, n.
65/ 65
Danish
ςαίσαγρε α αργόρΠ 2001- 2002
Sylvie Bénéfice, Head of Sector for conference services, b.
EMEA/ MB/ 003/ 01- EL -
28 December 1954, n.
νοτ αιγ ιατεζάγρΕ
French Education:
υοτ οιλίρπΑ νοτ όπα ΑΕΜΕ
DSc in physical sciences; qualification in research management; PhD in physical organic chemistry; Masters degree in physical organic
οτ ςωέ
Education:
νητ αιγ υοχγέλε ύοκιτσιγολ ςονυθύεπυ εξρήπυ Ernst and Young
Bachelor of Arts in languages and linguistics at the University of East Anglia and post-graduate degree in librarianship and information science at University of Wales.
οτ ςωέ 1974
chemistry; Degree in biochemistry.
1985 ονίλβυο∆ οτσ εκητσάγρε
From 1982 to 1986, Dr Bénéfice was a researcher at the University of Montpellier, France.
οτ όπΑ αρε ήσ ιρχέ αί ορδοιδατΣ
In 1986 she joined the French National Scientific Research Centre (CNRS) as
αίναπσΙ νητσ
Career to date:
Registroυοτ ςολέΜ ιακ
Ms Fayl joined the EMEA in April 1995.
Censor Jurado de Cuentas
44 EMEA Work Programme 2001-2002
υοτ ςητάγρενυΣ υονίλβυο∆ υοτ.
Chargé de recherche 1st Class and became officer for European affairs in 1991.
υοτ νώδυοπσ νώκιροπ ε οίχυτΠ ησυεδίαπκΕ
From 1993 to 1997 she was seconded to the European Commission (DG XII) as Scientific Secretary for COST actions in the field of chemistry, with responsibility for coordination of research networks and organisation of scientific conferences and workshops in Europe.
University College
She joined the EMEA in September 1997.
ςατητόοκηπυ ςήκιδναλρι
Administration Unit
υοίρβωτκΟ
Andreas Pott, Head of Unit, b.
14
14 April 1949, n.
Gerard O’ Malley,
German Education:
εσητέρηπυ αιγ ςωπό οισό ηδ
Masters Degree in political
κ Η νωγρΈ νωίσο η∆ ιακ νώκι ονοκιΟ ςαίεγΥ αίεγρυοπΥ ατσ α γιεδάραπ.
Frances Nuttall, Head of Sector, Personnel, budget and facilities, b.
ονίλβυο∆ οτσ
11 November 1958, n.
Trinity College,
Irish
οτ όπα άκι ονοκιο ατσ
science, history and English from the University of Hamburg.
ιακ ησηκίοιδ αισό ηδ ητσ
Certificat de Hautes Etudes Européennes (economics) from the College of Europe, Bruges.
ςοχοτάΚ
Education:
ιακ ύο σιγολοπϋορπ ύοκιπωσορπ αέ οτ ηνέ ατσϊορΠ
Master of Science in economics and Bachelor of Science in public administration from Trinity College Dublin.
,
Career to date:
υοτ οιάΜ
Ms Nuttall held several posts in the Irish Civil
Frances Nuttall, 2000.
Career to date:
οτ όπα ιατεζάγρε ΑΕΜΕ νοτΣ ςαίσαγρενυσ ςήκιναγροιδ ςοτα ή τ υοτ ςονε άτσϊορπ ςω
From 1972 to 1989 Mr Pott held a number of teaching and research posts, including a research fellowship at the Institute of Peace Research and Security Policy, University of Hamburg.
1999
He moved to the Translation Centre for Bodies of the European Union in 1999 as Head of the Department for Interinstitutional Cooperation.
κ Ο υογρύοβ Α υοτ.
He joined the EMEA in May 2000.
ιακ νώκιτκαδιδ άριεσ αί εχίετακ
Service, serving in the Departments of Health, Finance and the Office of Public Works.
όπα υοτ ςοχοτάΚ υογρύοβ Α υοτ οι ήτσιπεναΠ οτ όπα
Ms Nuttall then served with the Food and Agriculture Organisation of the United Nations from 1990 to 1995.
« Certificat de Hautes Etudes Européennes »
She joined the EMEA in May 1995.
υοίχυτπ ςοχοτάΚ ησυεδίαπκΕ master
Gerard O’Malley, Head of Sector, Accounting, b.
14
14 October 1950, n.
ςιτσ ςίεθηννεγ ςαδάνο ςονε άτσϊορΠ,
Bachelor of Commerce from University College Dublin.
Andreas Pott,
Career to date:
ςησηκίοιδ αδάνοΜ υοτ οιρβ έτπεΣ νοτ όπα ΑΕΜΕ νοτ αιγ ιατεζάγρΕ νωίρδενυσ
From 1971 to 1974, Mr O’Malley completed articles in Dublin.
ησωνάγροιδ νητ ε ιακ ηπώρυΕ νητσ ςανυερέ νωύτκιδ νωτ ό σινοτνυσ οτ ε εκηθήλοχσα
He joined the EMEA in April 1995.
EMEA/ MB/ 049/ 01- EL
EMEA/ MB/ 049/ 01-EN-Final
ΠΡΟΓΡΑΜΜΑ ΕΡΓΑΣΙΑΣ ΤΟΥ ΕΥΡΩΠΑΪΚΟΥ ΟΡΓΑΝΙΣΜΟΥ ΓΙΑ ΤΗΝ ΑΞΙΟΛΟΓΗΣΗ ΤΩΝ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ
WORK PROGRAMME FOR THE EUROPEAN AGENCY FOR THE EVALUATION OF MEDICINAL PRODUCTS
Εγκρίθηκε από το διοικητικό συµβούλιο την 18η ∆εκεµβρίου 2001
Adopted by the Management Board on 18 December 2001
Tο πρόγραµµα εργασίας για το 2002 υποβάλλεται στο διοικητικό συµβούλιο από τον γενικό διευθυντή σύµφωνα µε το άρθρο 57, παράγραφος 3, του κανονισµού (ΕΟΚ) αριθ.
The Work Programme for 2002 is presented by the Executive Director to the Management Board in accordance with Article 57(3) of Council Regulation (EEC) No 2309/ 93.
2309/ 93 του Συµβουλίου. ∆ιαβιβάζεται στο Ευρωπαϊκό Κοινοβούλιο, το Συµβούλιο, την Επιτροπή και τα κράτη µέλη. ∆ιατίθεται κατόπιν αιτήσεως σε όλες τις επίσηµες γλώσσες της ΕΕ.
It is available on request in all official EU languages.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. eu. int http: // www. emea. eu. int Περιεχόµενα
(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 2002 Reproduction and/ or distribution of this document is authorised for non-commercial purposes only provided the EMEA is acknowledged Contents
ΣΗΜΑΝΤΙΚΗ ΝΟΜΟΘΕΣΙΑ ΚΑΙ ΣΗΜΑΝΤΙΚΑ ΕΓΓΡΑΦΑ ΟΣΟΝ ΑΦΟΡΑ ΤΟΝ ΕΜΕΑ ΕΙΣΑΓΩΓΗ ΑΠΟ ΤΟ ΓΕΝΙΚΟ ∆ΙΕΥΘΥΝΤΗ ∆ΟΜΗ ΤΟΥ EMEA
EMEA KEY LEGISLATION AND DOCUMENTS INTRODUCTION BY THE EXECUTIVE DIRECTOR STRUCTURE OF THE EMEA
ΚΕΦΑΛΑΙΟ 1 Ο ΕΜΕΑ ΣΤΟ ΕΥΡΩΠΑΪΚΟ ΣΥΣΤΗΜΑ 1. 1 ∆ιοικητικό συµβούλιο 1. 2 ∆ίκτυο µε τις εθνικές αρµόδιες αρχές 1. 3 ∆ιαφάνεια και κανονιστικός διάλογος 1. 4 Αναθεώρηση των τελών του ΕΜΕΑ 1. 5 Επανεξέταση του ευρωπαϊκού συστήµατος χορήγησης άδειας κυκλοφορίας
CHAPTER 1 EMEA IN THE EUROPEAN SYSTEM 1.1 Management Board 1.2 Network with national competent authorities 1.3 Transparency and regulatory dialogue 1.4 Revision of EMEA fees 1.5 Review of the European marketing authorisation system 1.6 Quality management
7 7 8 8 9 9
7 7 8 8 9 9 9
1. 6 ∆ιαχείριση ποιότητας 1. 7 ∆ιεθνείς εταίροι 1. 8 Ευρωπαϊκή Υπηρεσία για την Ποιότητα των Φαρµάκων 1. 9 ∆ηµοσιονοµικός έλεγχος
International partners European Department for the Quality of Medicines Financial control
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10 11 12
ΚΕΦΑΛΑΙΟ 2 ΦΑΡΜΑΚΕΥΤΙΚΑ ΠΡΟΪΟΝΤΑ ΓΙΑ ΑΝΘΡΩΠΙΝΗ ΧΡΗΣΗ 2. 1 Αρχική αξιολόγηση 2. 2 ∆ραστηριότητες µετά τη χορήγηση άδειας κυκλοφορίας 2. 3 ∆ραστηριότητες φαρµακοεπαγρύπνησης και διατήρησης 2. 4 Επιστηµονικές συµβουλές 2. 5 ∆ιαιτησία και κοινοτικές παραπεµπτικές διαδικασίες 2. 6 Ειδικές υπηρεσίες 2. 7 ∆ιεθνείς δραστηριότητες 2. 8 Ορφανά φάρµακα 2. 9 Οµάδες εργασίας CPMP και COMP και ειδικές (ad hoc) οµάδες εργασίας 2. 10 Οµάδα για τη διευκόλυνση της αµοιβαίας αναγνώρισης
CHAPTER 2 MEDICINES FOR HUMAN USE 2.1 Initial evaluation 2.2 Post-authorisation activities 2.3 Pharmacovigilance and maintenance activities 2.4 Scientific advice 2.5 Arbitration and Community referrals 2.6 Special services 2.7 International activities 2.8 Orphan medicinal products 2.9 CPMP and COMP working parties and ad hoc groups 2.10 Mutual recognition facilitation group
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13 15 17 17 19 20 20 20 21 23 24
ΚΕΦΑΛΑΙΟ 3 ΚΤΗΝΙΑΤΡΙΚΑ ΦΑΡΜΑΚΕΥΤΙΚΑ ΠΡΟΪΟΝΤΑ 3. 1 Αρχική αξιολόγηση 3. 2 Καθορισµός ανώτατων ορίων καταλοίπων (ΑΟΚ/ MRL) για παλαιές ουσίες 3. 3 ∆ραστηριότητες µετά τη χορήγηση άδειας κυκλοφορίας 3. 4 ∆ραστηριότητες φαρµακοεπαγρύπνησης και διατήρησης 3. 5 Επιστηµονικές συµβουλές 3. 6 ∆ιαιτησία και κοινοτικές παραπεµπτικές διαδικασίες 3. 7 Ενδιαφερόµενα µέρη 3. 8 ∆ιεθνείς δραστηριότητες 3. 9 Οµάδες εργασίας και ειδικές (ad hoc) οµάδες 3. 10 Κτηνιατρική οµάδα για τη διευκόλυνση της αµοιβαίας αναγνώρισης
CHAPTER 3 VETERINARY MEDICINES 3.1 Initial evaluation 3.2 Establishment of maximum residue limits for old substances 3.3 Post-authorisation activities 3.4 Pharmacovigilance and maintenance activities 3.5 Scientific advice 3.6 Arbitration and Community referrals 3.7 Interested parties 3.8 International activities 3.9 Working parties and ad hoc groups 3.10 Veterinary mutual recognition facilitation group
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25 27 28 28 29 29 29 29 30 30 31
ΚΕΦΑΛΑΙΟ 4 ΕΠΙΘΕΩΡΗΣΕΙΣ
CHAPTER 4 INSPECTIONS
ΚΕΦΑΛΑΙΟ 5 ∆ΙΟΙΚΗΣΗ ΚΑΙ ∆ΡΑΣΤΗΡΙΟΤΗΤΕΣ ΥΠΟΣΤΗΡΙΞΗΣ 5. 1 ∆ιοίκηση 5. 2 ∆ιαχείριση και δηµοσίευση εγγράφων 5. 3 ∆ιαχείριση των συνεδριάσεων και υπηρεσίες συνεδρίων 5. 4 ∆ιαχείριση σχεδίων 5. 5 Τεχνολογία πληροφοριών
CHAPTER 5 ADMINISTRATION AND SUPPORT ACTIVITIES 5.1 Administration 5.2 Document management and publishing 5.3 Meeting management and conferences 5.4 Project management 5.5 Information technology
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34 34 36 37 38 39
ΠΑΡΑΡΤΗΜΑΤΑ Παράρτηµα 1 Πίνακας προσωπικού του EMEA για την περίοδο 2000 – 2002 Παράρτηµα 2 Συνοπτικοί προϋπολογισµοί του EMEA για την περίοδο 2000 – 2002 Παράρτηµα 3 Κατευθυντήριες οδηγίες του EMEA για το 2002 Παράρτηµα 4 Επικοινωνία µε τον EMEA Παράρτηµα 5 Σύντοµα βιογραφικά σηµειώµατα των βασικών στελεχών του EMEA
ANNEXES Annex 1 EMEA establishment plan 2000 – 2002 Annex 2 EMEA budget summaries 2000 – 2002 Annex 3 EMEA guidelines for 2002 Annex 4 EMEA contact points Annex 5 Profiles of EMEA personalities
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2/ 63 Σηµαντική νοµοθεσία και σηµαντικά έγγραφα όσον αφορά τον ΕΜΕΑ Ο ΕΜΕΑ ιδρύθηκε µε τον κανονισµό (ΕΚ) αριθ.
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 EMEA key legislation and documents