qanastek/EMEA-V3 huggingface dataset:
Titel des Dokuments 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:
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:
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 tetanus 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)
47/64 CPMP-Arbeitsgruppe Wirksamkeit
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 CPMP Efficacy Working Party
Titel des Dokuments 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 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:
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:
Adjustment for multiplicity and related topics 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 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 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:
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 women 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
48/64 CPMP-Arbeitsgruppe Sicherheit
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 CPMP Safety Working Party
Titel des Dokuments Revision of Note for guidance on carcinogenic potential (3BS7a, Volume 3B, 1998, p.
Document title 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 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
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
CVMP-Arbeitsgruppe Wirksamkeit
CVMP Efficacy Working Party
Titel des Dokuments Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy
Document title Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy
Titel des Dokuments 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:
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:
Need for post-marketing data Contribution to CPMP Points to consider document on xenogeneic cell therapy Proposals for revision to Standard operating procedure on urgent safety restrictions for medicinal products authorised through the mutual recognition procedure
Need for post-marketing data Contribution to CPMP Points to consider document on xenogeneic cell therapy Proposals for revision to Standard operating procedure on urgent safety restrictions for medicinal products authorised through the mutual recognition procedure
Titel des Dokuments 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:
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:
49/64 CVMP-Arbeitsgruppe Pharmakovigilanz
 EMEA 2002 Page 47/ 62
Titel des Dokuments VICH:
Document title VICH:
Titel des Dokuments Safety evaluation of antimicrobial substances regarding the effects on human gut flora VICH:
Document title Safety evaluation of antimicrobial substances regarding the effects on human gut flora VICH:
Pre-approval information for registration of new medicinal products for food producing animals with respect to antimicrobial resistance VICH:
Pre-approval information for registration of new medicinal products for food producing animals with respect to antimicrobial resistance VICH:
Carcinogenicity testing Pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
Carcinogenicity testing Pre-authorisation studies to assess the potential for resistance resulting from the use of antimicrobial veterinary medicinal products
Titel des Dokuments 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:
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:
50/64 Anhang 4 Ansprechpartner bei der EMEA
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 4 EMEA contact points
Die ständige Überwachung der Sicherheit von Arzneimitteln nach der Zulassung („ Pharmakovigilanz“) ist ein wichtiger Teil der Arbeit der zuständigen nationalen Behörden und der EMEA.
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.
Die EMEA erhält Sicherheitsmeldungen über zentral zugelassene Arzneimittel von innerhalb und außerhalb der EU und koordiniert Maßnahmen in Bezug auf Sicherheit und Qualität von Arzneimitteln.
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.
Pharmakovigilanz von Humanarzneimitteln betreffende Angelegenheiten
For matters relating to pharmacovigilance for medicinal products for human use
Noël WATHION Durchwahl (44-20) 74 18 85 92 E-Mail: noel.wathion@emea.eu.int
Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eu. int
Pharmakovigilanz von Tierarzneimitteln betreffende Angelegenheiten
For matters relating to pharmacovigilance for medicinal products for veterinary use
Barbara FREISCHEM Durchwahl (44-20) 74 18 85 81 E-Mail: barbara.freischem@emea.eu.int
Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara. freischem@emea. eu. int
Produktmängel und sonstige qualitätsbezogene Angelegenheiten
For product defect and other quality-related matters
Francisco PEÑARANDA FERNANDEZ Faxnummer für Schnellwarnungen von Produktmängeln (44-20) 74 18 85 90 E-Mail: francisco.penaranda@emea.eu.int
Francisco PEÑARANDA FERNANDEZ Fax number for defective product rapid alerts (44-20) 74 18 85 90 E-mail: francisco. penaranda@emea. eu. int
Arzneimittelbescheinigungen
Certificates of a medicinal product
Die EMEA stellt Arzneimittelbescheinigungen gemäß den Bestimmungen der Weltgesundheits- organisation aus.
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organisation.
Diese attestieren die Zulassung sowie den Status der Guten Herstellungspraxis von Arzneimitteln in der EU und sind als Unterstützung für Anträge auf Genehmigung für das Inverkehrbringen bzw. den Export in Nicht-EU Länder bestimmt.
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.
Anfragen zu Bescheinigungen für zentral zugelassene Human- und Tierarzneimittel
For enquiries concerning certificates for centrally authorised medicines for human or veterinary use
Jonna SUNELL-HUET Durchwahl (44-20) 74 18 84 65 E-Mail: certificate@emea.eu.int
Jonna SUNELL-HUET Direct telephone (44-20) 74 18 84 65 E-mail: certificate@emea. eu. int
Dokumentationsdienste
Documentation services
Pressemitteilungen, allgemeine Informationen, Jahresberichte und Arbeitsprogramme.
A wide range of documents has now been published by the EMEA, including press releases, general information documents, annual reports and work programmes.
Diese und weitere Dokumente sind im Internet (http://www.emea.eu.int) sowie unter folgender Anschrift erhältlich:
These and other documents are available either on the Internet at http: / /www. emea. eu. int or by writing to:
Subscription Service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf UK – London E14 4HB
Subscription Service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf UK - London E14 4H
51/64 Alle öffentlichen Dokumente der EMEA können in elektronischer Form oder auf Papier abonniert werden.
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.
Weitere Informationen erhalten Sie unter obiger obiger Anschrift sowie von
Further information can be obtained from the Iro MAVROPOULOS
Iro MAVROPOULOS Durchwahl (44-20) 74 18 85 82 E-Mail: subscriptions@emea.eu.int
above address or from Direct telephone (44-20) 74 18 85 E-mail: subscriptions@emea. eu. int
Anfragen nach allgemeinem Informationsmaterial sind zu richten an
Requests for general information packs should be sent to
Amanda BOSWORTH Durchwahl (44-20) 74 18 84 08 E-Mail: amanda.bosworth@emea.eu.int
Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda. bosworth@emea. eu. int
Listen europäischer Sachverständiger
European experts lists
Die Listen europäischer Sachverständiger können auf Anfrage in den Diensträumen der EMEA eingesehen werden.
The list of European experts is available for examination on request at the EMEA offices.
Liste der Sachverständigen für Humanarzneimittel
Human medicines’ experts list
human_experts@emea.eu.int
human_experts@emea. eu. int
Liste der Sachverständigen für Tierarzneimittel
Veterinary medicines ’ experts list
vet_experts@emea.eu.int
vet_experts@emea. eu. int
Liste der sachverständigen Inspektoren
Inspectors ’ experts list
inspectors_experts@emea.eu.int
inspectors_experts@emea. eu. int
Pressestelle
Press office
Pressebeauftragter
Press officer
Martin HARVEY Durchwahl (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
52/64 Anhang 5 Leitende EMEA-Mitarbeiter im Porträt
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 5 Profiles of EMEA personalities
Keith Jones, Vorsitzender des Verwaltungsrates, geboren am 14.
Keith Jones, Chairman of the Management Board, b.
Oktober 1937, Brite
14 October 1937, n.
Jones hatte nach Abschluss seiner medizinischen Ausbildung verschiedene Positionen in der klinischen Medizin und Forschung an Universitätskliniken im Vereinigten Königreich inne.
Dr Jones is qualified in medicine and has held posts in clinical medicine and research at UK teaching hospitals.
Anschließend absolvierte er in der agrochemischen Industrie eine Ausbildung zum Toxikologen.
He then trained as a toxicologist in the agrochemical industry.
Jones war 22 Jahre in der Industrie tätig, und zwar als Leiter der medizinischen Abteilung von Fisons Agrochemical Divisions, Leiter für Sicherheitsbewertung und klinische Pharmakologie bei Beecham Pharmaceuticals und Direktor für medizinische Angelegenheiten bei Merck Sharp & Dohme in den USA.
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.
Derzeit ist Dr.
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.
Jones, der auf zahlreiche Publikationen verweisen kann, Gastprofessor für Pharmakologie an der Pharmazeutischen Fakultät der Londoner Universität.
He is currently visiting Professor of Pharmacology at the School of Pharmacy University of London and has published widely.
Er trat 1995 dem EMEA-Verwaltungsrat bei und wurde 2001 zum Vorsitzenden gewählt.
Dr Jones joined the EMEA Management Board in 1995 and was elected chairman of the Board in 2001.
Gerhard Kothmann, stellvertretender Vorsitzender des Verwaltungsrates, geboren am 23.
Gerhard Josef Kothmann, Vice-Chairman of the Management Board, b.
Juli 1943, Deutscher
German
Kothmann 1970 zum Bundesforschungszentrum für Viruskrankheiten bei Tieren und 1972 zur Veterinärmedizinischen Verwaltung in Niedersachsen.
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.
1975 wechselte er zum Bundesministerium für Gesundheit, wo er mehrere Ämter innehatte, so war er u. a. in der für die Tierarzneimittel-Industrie zuständigen Abteilung tätig und beteiligte sich 1990 am Wiederaufbau der veterinärmedizinischen Einrichtungen in den neuen Bundesländern.
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.
1991 wurde er zum Leitenden Veterinärbeamten ernannt.
He was appointed Chief Veterinary Officer in 1991.
Kothmann trat 1996 dem EMEA-Verwaltungsrat bei und wurde 2000 zum stellvertretenden Vorsitzenden gewählt.
Dr Kothmann joined the EMEA Management Board in 1996 and was elected vice-chairman in 2000.
Thomas Lönngren, Direktor, geboren am 16.
Thomas Lönngren, Executive Director, b.
Master-Abschluss in sozialer Pharmazie und Arzneimittelrecht.
MSc in social and regulatory pharmacy.
Von 1982 bis 1994 fungierte er als Leitender Pharmazeutischer Berater für das schwedische Gesundheitskooperationsprogramm in Vietnam.
He acted as senior pharmaceutical consultant for the Swedish health cooperation programme in Vietnam from 1982 to 1994.
53/64 Wissenschaftliche Ausschüsse der EMEA
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 EMEA scientific committees
Daniel Brasseur, Vorsitzender des CPMP, geboren am 7.
Daniel Brasseur, Chairman of the CPMP, b.
Juni 1951, Belgier
Belgian
Abschluss als Doktor der Medizin an der Freien Universität Brüssel.
Qualified medical doctor from the Free University of Brussels.
Postgraduale Abschlüsse in Pädiatrie und als Doktor für Ernährungswissenschaften.
Post-graduate degree in paediatrics and a PhD in nutrition.
Brasseur Kinderarzt am Universitätskrankenhaus Sint Pieter in Brüssel.
From 1976 to 1986 Dr Brasseur worked as a paediatrician at the University Sint Pieter Hospital in Brussels.
Nach einem kurzen Abstecher in die pharmazeutische Industrie in den Jahren 1986/1987 wandte er sich wieder der klinischen Tätigkeit zu, indem er in der Universitätskinderklinik Königin Fabiola in Brüssel das Amt des Leiters der Abteilung Ernährungswissenschaft und Pharmakodynamik übernahm, das er bis heute innehat.
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.
1997 wurde er Medizinischer Hauptsachverständiger bei der Arzneimittelinspektion des belgischen Ministeriums für Volksgesund- heit.
He joined the Pharmaceutical Inspectorate of the Belgian Ministry of Public Health as head of medical assessors in 1997.
Eric Abadie, stellvertretender Vorsitzender des CPMP, geboren am 14.
Eric Abadie, Vice-chairman of the CPMP, b.
Juli 1950, Franzose
French
Postgraduale Abschlüsse in innerer Medizin, Endokrinologie, Diabetologie und Kardiologie.
Post-graduate qualifications in internal medicine, endocrinology, diabetology and cardiology.
Außerdem Abschluss als Master of Business Administration.
He also holds an MBA.
Abadie hatte von 1981 bis 1983 verschiedene Positionen im klinischen und Laborbereich inne und nahm 1983 eine Tätigkeit in der pharmazeutischen Industrie auf.
From 1981 to 1983 Dr Abadie held a number of clinical and laboratory positions, before joining the pharmaceutical industry in 1983.
Von 1985 bis 1993 war er Direktor für medizinische Angelegenheiten beim französischen Pharmazieverband, wonach er bis 1994 in die pharmazeutische Industrie zurückkehrte.
He was director of medical affairs of the French pharmaceutical trade association from 1985 to 1993 and returned to industry until 1994.
Steve Dean, Vorsitzender des CVMP, geboren am 2 August 1951, Brite
British
Steve Dean war in der veterinärmedizinischen Praxis, als Dozent für Anatomie und Radiologie am Royal Veterinary College in London sowie in fachlichen und verwaltungstechnischen Positionen in der Tierarzneimittel-Industrie tätig.
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.
Gérard Moulin, stellvertretender Vorsitzender des CVMP, geboren am 18.
Gérard Moulin, Vice-chairman of the CVMP, b.
Oktober 1958, Franzose
French
1984 übernahm er beim Veterinärmedizinischen Labor in Fougères die Funktion des Sachverständigen und Berichterstatters für Zulassungsdossiers.
In 1984, he joined the Veterinary Medicines Laboratory in Fougères where he was assessor and rapporteur for marketing authorisation dossiers.
54/64 Josep Torrent i Farnell, Vorsitzender des COMP, geboren am 2.
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Josep Torrent i Farnell, Chairman of the COMP, b.
Studienabschlüsse in Pharmazie, Medizin und Chirurgie an der Universität Barcelona sowie postgraduale Studien auf den Gebieten Pharmakologie und Toxikologie, öffentliche Gesundheit und europäische Institutionen.
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
Facharzt für innere Medizin und klinische Pharmakologie.
Specialist in internal medicine and clinical pharmacology.
Promotion in klinischer Pharmakologie an der Autonomen Universität Barcelona (UAB).
Doctorate pharmacology from the Autonomous University of Barcelona (UAB).
Von 1977 bis 1990 war Prof.
From 1977-1990, Prof.
1992 wurde er Professor für klinische Pharmakologie und Therapeutik sowie Direktor des Master-/Diplom- Studiengangs für Europäische Arzneimittelzulassung (UAB).
In 1992, he became Professor of Clinical Pharmacology and Therapeutics and Director of the Masters/ Diploma course on European Registration of Medicinal Products (UAB).
Im November 2000 wurde er Generaldirektor des Dienstleistungs- und Ausbildungszentrums für Gesundheits- und Biowissenschaften bei der Dr.-Rober-Stiftung (UAB).
Rober Foundation (UAB).
Yann Le Cam, stellvertretender Vorsitzender des COMP, geboren am 15.
Yann Le Cam, Vice-chairman of the COMP, b.
Juli 1961, Franzose
French
Studienabschluss in Betriebswirtschaftslehre am Institut Supérieur de Gestion in Paris.
He is a graduate in business administration from the Institut Supérieur de Gestion in Paris.
MBA-Abschluss am Centre de Perfectionnement aux Affaires, Groupe HEC-CPA, 2000, Jouy-en- Josas, Frankreich.
He also holds an MBA from the Centre de Perfectionnement aux Affaires, Groupe HEC-CPA, 2000, Jouy-en-Josas, France.
In dieser Zeit war er bei Nichtregierungsorganisationen in Frankreich, Europa und den USA auf dem Gebiet der Erforschung von Krebs, AIDS und genetischen Erkrankungen tätig.
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.
Von 1992 bis 1998 hatte er das Amt des Direktors der AIDES Fédération Nationale inne.
He served as Director-General of AIDES Fédération Nationale from 1992 to 1998.
Außerdem ist er stellvertretender Vorsitzender der International Alliance of Patients Organisations (IAPO), deren Sitz sich in London befindet.
He is also the Vice- Chairman of the International Alliance of Patients Organisations (IAPO) based in London.
55/64 Referat für die Beurteilung von Humanarzneimitteln vor der Zulassung
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Unit for the Pre-authorisation evaluation of medicines for human use
August 1950, Franzose
French
Postgraduale Abschlüsse in Tropenmedizin, klinischer Forschung und Epidemiologie.
Post-graduate degrees in tropical medicine, clinical research and epidemiology.
Le Courtois als praktischer Arzt und als Direktor eines medizinischen Zentrums in Paris tätig.
From 1977 to 1986, Dr Le Courtois worked as a general practitioner and as director of a medical centre in Paris.
1986 ging er an die Universität Bordeaux und betrieb Forschungen auf dem Gebiet der öffentlichen Gesundheit, darunter in den Bereichen Epidemiologie, klinische Forschung, Pharmakovigilanz, Tropen- und Infektionskrankheiten, Ökonomie des Gesundheitswesens und Gesundheitserziehung.
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.
1993 wurde er Leiter der Stelle für europäische Verfahren bei der französischen Arzneimittelbehörde und CPMP-Berichterstatter.
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.
Er ist seit September 1997 bei der EMEA beschäftigt und wurde im Juni 1998 zum Leiter des Bereichs Neue chemische Substanzen und im Januar 2001 zum Leiter des Bereichs Wissenschaftliche Beratung und Arzneimittel für seltene Leiden ernannt.
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.
Agnès Saint Raymond, Leiterin des Bereichs Wissenschaftliche Beratung und Arzneimittel für seltene Leiden, geboren am 7.
Agnès Saint Raymond, Head of Sector for orphan drugs and scientific advice, b.
September 1956, Französin
French
Abschluss als Doktor der Medizin an der Pariser Universität.
Qualified medical doctor from the University of Paris.
Postgraduale Abschlüsse in Pädiatrie und Methodik.
Post-graduate qualifications in paediatrics and methodology.
Saint Raymond war zunächst als Kinderärztin in einem Lehrkrankenhaus für Kinderheilkunde und anschließend mehrere Jahre für verschiedene pharmazeutische Unternehmen tätig.
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.
Im Jahre 1995 wurde sie Leiterin des Referats für pharmakotoxisch-klinische Evaluation bei der französischen Arzneimittelbehörde.
In 1995 she joined the French Medicines Agency as Head of Unit for pharmaco-toxico-clinical assessment.
Im Januar 2000 kam sie zur EMEA, wo sie im Dezember 2001 zur Leiterin des Bereichs Wissenschaftliche Beratung und Arzneimittel für seltene Leiden ernannt wurde.
She joined the EMEA in January 2000 and was appointed Head of Sector for Scientific Advice and Orphan Drugs in December 2001.
Außerdem ist sie für Fragen im Zusammenhang mit der Anwendung von Arzneimitteln bei Kindern zuständig.
She is also in charge of issues relating to medicines used in children.
John Purves, Leiter des Bereichs Qualität von Arzneimitteln, geboren am 22.
John Purves, Head of Sector for quality of medicines, b.
April 1945, Brite
22 April 1945, n.
Purves in der pharmazeutischen Industrie.
From 1972 to 1974, Dr Purves worked in the pharmaceutical industry.
Von 1974 bis 1996 war er in verschiedenen Funktionen in der Medicines Division und der Medicines Control Agency des Vereinigten Königreichs tätig, unter anderem als Inspektor für Arzneimittelherstellung, Dossierprüfer und Leiter der Ressorts für Biotechnologie und biologische Präparate.
Between 1974 and 1996, he held posts in the UK Medicines Division and the Medicines Control Agency, including inspector of pharmaceutical manufacture, reviewer of dossiers and manager of the Biotechnology and Biological Unit.
Er vertrat das Vereinigte Königreich in der Arbeitsgruppe Biotechnologie und wirkte an der Erarbeitung zahlreicher Leitlinien zu Biotechnologie und biologischen Präparaten mit.
He was the UK representative at the Biotechnology Working Party, involved in the generation of many guidelines relating to biotechnology and biological products.
Er kam zur EMEA im August 1996 als Leiter des Bereichs Biotechnologie und biologische Präparate.
He joined the EMEA in August 1996 as Head of Sector for biotechnology and biologicals.
Im Januar 2001 wurde er zum Leiter des Bereichs Qualität von Arzneimitteln ernannt.
He was appointed Head of Sector for quality of medicines in January 2001.
Isabelle Moulon, Leiterin des Bereichs Sicherheit und Wirksamkeit von Arzneimitteln, geboren am 9.
Isabelle Moulon, Head of Sector for safety and efficacy of medicines, b.
März 1958, Französin
French
Abschluss als Doktor der Medizin an der Universität Grenoble, Frankreich.
Qualified medical doctor from the University of Grenoble, France.
Fachärztin für Endokrinologie.
Specialist in endocrinology.
Postgraduale Studien in Statistik, Methodik und Ernährungswissenschaft.
Post-graduate studies in statistics, methodology and nutrition.
Bis 1987 Tätigkeit als Endokrinologin in einem französischen Krankenhaus, danach Wechsel zur Pharmazie-Direktion beim französischen Gesundheitsministerium.
Worked as a clinical endocrinologist in a French hospital until 1987 and then joined the Directorate of Pharmacy at the French Ministry of Health.
Von 1992 bis 1995 arbeitete sie für die pharmazeutische Industrie, bevor sie im Juli 1995 ihre Arbeit in der EMEA
She worked for the pharmaceutical industry from 1992 to 1995 before joining the EMEA in July 1995.
Im Januar 2001 wurde sie zur Leiterin des Bereichs Sicherheit und Wirksamkeit von Arzneimitteln ernannt.
She was appointed Head of Sector for safety and efficacy of medicines in January 2001.
Marisa Papaluca Amati, stellvertretende Leiterin des Bereichs Sicherheit und Wirksamkeit von Arzneimitteln, geboren am 12.
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Marisa Papaluca Amati, Deputy Head of Sector for safety and efficacy of medicines, b.
Oktober 1954, Italienerin
Italian
Abschluss in Medizin und Chirurgie an der Universität Rom.
Degree in medicine and surgery from the University of Rome.
Fachärztin für innere Medizin.
Specialist in internal medicine.
Postgraduale Studien in Kardiologie und Endokrinologie.
Post-graduate studies in cardiology and endocrinology.
Papaluca als Forschungsattaché an der Staatlichen Universität Rom an Projekten auf dem Gebiet der klinischen Immunologie, Onkologie und zellulären Immunologie.
From 1978 to 1983 Dr Papaluca worked as a research fellow in the State University of Rome on projects in the area of clinical immunology, oncology and cellular immunology.
Dr.
From 1984 to 1994, as medical director of the Pharmaceutical Department of the Italian Ministry of Health, she was in charge of the Operative Centre for Community Procedures and was an Italian member of the former Committee for Proprietary Medicinal Products.
Papaluca war EU-Berichterstatterin für ein wirksamkeitsspezifisches Thema der ICH und Mitglied der internationalen CIOMS-Arbeitsgruppen I und II zur Pharmakovigilanz.
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.
Seit Oktober 1994 arbeitet sie bei der EMEA.
She joined the EMEA in October 1994.
Im Januar 2001 wurde sie zur stellvertretenden Leiterin des Bereichs Sicherheit und Wirksamkeit von Arzneimitteln ernannt.
She was appointed Deputy Head of Sector for safety and efficacy of medicines in January 2001.
57/64 Referat für die Beurteilung von Humanarzneimitteln nach der Zulassung
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Unit for the Post-authorisation evaluation of medicines for human use
Noël Wathion, Referatsleiter, geboren am 11.
Noël Wathion, Head of Unit, b.
September 1956, Belgier
Belgian
Herr Wathion arbeitete zunächst als Apotheker.
Mr Wathion first worked as pharmacist in a retail pharmacy.
Später wurde er als Leitender Inspektor an die Pharmazie-Inspektion beim Ministerium für soziale Angelegenheiten und Volkgesundheit in Brüssel berufen und war als Sekretär der belgischen Arzneimittelkommission tätig.
He was later appointed to the Pharmaceutical Inspectorate (Ministry of Social Affairs and Public Health) in Brussels as a Chief Inspector, acting as the Secretary of the Belgian Medicines Commission.
In der Vergangenheit gehörte er als belgisches Mitglied sowohl dem CPMP als auch dem CVMP an und war Vertreter im Pharmazeutischen Ausschuss, dem Ständigen Ausschuss und der Arbeitsgruppe Mitteilung an die Antragsteller.
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.
Bei der EMEA war er seit August 1996 als Leiter des Bereichs Zulassungsrechtliche Angelegenheiten und Pharmakovigilanz tätig, ehe er im September 2000 zum Referatsleiter ernannt wurde.
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.
Tony Humphreys, Leiter des Bereichs Zulassungsrechtliche Angelegenheiten und organisatorische Unterstützung, geboren am 12.
Tony Humphreys, Head of Sector for regulatory affairs and organisational support, b.
Dezember 1961, Ire
12 December 1961, n.
Bachelor-Abschluss in Pharmazie und Master-Abschlusss in Pharmazie auf dem Forschungsgebiet Mikroverkapselung am Trinity College in Dublin.
Qualified as a pharmacist, BSc (Pharm) and was granted a Masters degree in pharmaceutics in the research area of microencapsulation from Trinity College Dublin.
Seit seinem Abschluss im Jahre 1983 arbeitete Tony Humphreys im Bereich pharmazeutische Entwicklung für einen nationalen Hersteller von Markengenerika und für ein internationales Forschungs- und Entwicklungsunternehmen.
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.
Im Mai 1996 kam er zur EMEA und wurde im Januar 2001 zum Leiter des Bereichs Zulassungsrechtliche Angelegenheiten und organisatorische Unterstützung ernannt.
He joined the EMEA in May 1996 and was appointed Head of Sector for regulatory affairs and operational support in January 2001.
Noël Wathion, amtierender Leiter des Bereichs Pharmakovigilanz, Sicherheit und Wirksamkeit zugelassener Arzneimittel
Noël Wathion, Acting Head of Sector for pharmacovigilance, post-authorisation safety and efficacy of medicines
Sabine Brosch, stellvertretende Leiterin des Bereichs Pharmakovigilanz, Sicherheit und Wirksamkeit zugelassener Arzneimittel, geboren am 17.
Sabine Brosch, Deputy Head of Sector for pharmacovigilance, post-authorisation safety and efficacy of medicines, b.
Abschluss als Magister der Pharmazie und Promotion zum Doktor der Naturwissenschaften auf dem Gebiet der Pharmakologie an der Universität Wien.
Masters Degree in pharmacy and Doctor of Natural Sciences Degree in pharmacology from the University of Vienna.
1992 nahm sie im österreichischen Gesundheitsministerium eine Tätigkeit auf dem Gebiet der Arzneimittelüberwachung auf und absolvierte 1995 ein sechsmonatiges zulassungsrechtliches Praktikum im Referat Arzneimittel der Europäischen Kommission.
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.
58/64 Referat Tierarzneimittel und Inspektionen
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Unit for Veterinary medicines and inspections
Abschluss in Veterinärmedizin an der Fakultät für Veterinärwissenschaften der Universität Liverpool.
Graduated in veterinary medicine from the Faculty of Veterinary Science at Liverpool University and is a Member of the Royal College of Veterinary Surgeons of the United Kingdom.
Jones zur pharmazeutischen Industrie, wo er im Sektor Tiergesundheit arbeitete.
After several years in general veterinary practice in the United Kingdom and Canada, Dr Jones joined the pharmaceutical industry in the animal health sector.
Er war in verschiedener Stellung in den Forschungs- und Zulassungsabteilungen mehrerer multinationaler Unternehmen tätig, zuletzt als Leitender Direktor des Bereichs Internationale Zulassung von Tierarzneimitteln für die Firma Merck Sharp & Dohme in New Jersey/USA.
He has held a number of appointments in research and regulatory affairs in multinational companies and, most recently, as Senior Director of International Regulatory Affairs for Animal Health Products for Merck Sharp and Dohme in New Jersey, USA.
Seit Januar 2000 ist er für Informationstechnologie zuständig.
He joined the EMEA in June 1995, and was appointed Head of the Veterinary Unit in December of the same year and took on responsibility for information technology in January 2000.
Er ist EU-Koordinator der VICH.
He is EU coordinator in the VICH.
Jill Ashley-Smith, Leiterin des Bereichs Verfahren für die Zulassung von Tierarzneimitteln, geboren am 18.
Jill Ashley-Smith, Head of Sector for veterinary marketing authorisation procedures, b.
Dezember 1962, Britin
British
Abschluss in Pharmakologie am King's College der Universität London.
Graduated in pharmacology from Kings College, London University.
Abschluss in Veterinärmedizin am Royal Veterinary College der Universität London.
Qualified as a veterinary surgeon from the Royal Veterinary College, London University.
Ashley-Smith in der Tierarzneimittel-Industrie beschäftigt, zunächst als Technische Beraterin und anschließend als Zulassungsbeauftragte.
From 1987 to 1994, Dr Ashley-Smith was employed in the veterinary pharmaceutical industry, first as a technical adviser and subsequently as a registration manager.
Im Jahr 1994 begann sie eine Tätigkeit als veterinärmedizinische Hauptsachverständige bei der Arbeitsgruppe Arzneimittel und Futtermittelzusätze des Veterinary Medicines Directorate des Vereinigten Königreichs.
In 1994, she joined the UK Veterinary Medicines Directorate as senior veterinary assessor in the pharmaceuticals and feed additives team.
Ab 1996 arbeitete sie als Mitglied des Vereinigten Königreichs im CVMP mit, bis sie im Juli 1997 zur EMEA wechselte.
She participated as UK CVMP member from 1996 until joining the EMEA in July 1997.
Melanie Leivers, stellvertretende Leiterin des Bereichs Verfahren für die Zulassung von Tierarzneimitteln, geboren am 1.
Melanie Leivers, Deputy Head of Sector for veterinary marketing authorisation procedures, b.
Dezember 1958, Britin
British
Abschluss in Biochemie und Pharmakologie an der Universität Leeds.
Graduate in biochemistry and pharmacology from Leeds University.
Postgraduales Diplom in Europäischem Gemeinschaftsrecht am King’ s College, London.
Post-graduate diploma in European Community law from King’ s College, London.
Nach fünfjähriger Tätigkeit als Amtschemikerin für das Milk Marketing Board für England und Wales (MMB) wurde Melanie Leivers zur stellvertretenden Direktorin des Brüsseler Büros des MMB/Federation of Agricultural Cooperatives ernannt, wo sie alle Agrarbereiche gegenüber den EU-Organen vertrat.
Miss Leivers worked for the Milk Marketing Board for England and Wales (MMB) as a Liaison Chemist for 5 years prior to being appointed Assistant Director of the MMB/ Federation of Agricultural Cooperatives office in Brussels, representing all sectors of agricultural cooperation to the European institutions.