qanastek/EMEA-V3 huggingface dataset:
Once this has been achieved, work will be undertaken to implement electronic workflows for a selected number of areas of activity in the Agency.
Una vez logrado esto, se trabajará en la puesta en marcha de flujos de trabajo electrónicos para determinadas áreas de actividad de la Agencia.
The implementation will continue in order to complete electronic workflows wherever appropriate throughout the Agency before the end of 2004.
Se proseguirá con la aplicación de flujos de trabajo electrónicos donde la Agencia los necesite antes del fin de 2004.
Contribute to the development of information publishing on the EMEA web site and manage the expected increase in documents.
Contribuir al desarrollo de la publicación de información en el sitio web de la EMEA y gestionar el aumento previsto de documentos.
The sector will also contribute to the ongoing supervision and management of the site.
El Sector también contribuirá a la actual supervisión y gestión del sitio web.
Implement a new publication strategy to ensure faster publication of key documents, including the launch of a tender for local printing of key documents such as annual reports and work programmes.
Puesta en marcha de una nueva estrategia de publicaciones que permita publicar antes los documentos claves, con el lanzamiento de una propuesta de licitación para impresión local de documentos clave, como informes anuales y programas de trabajo.
Manage the document dissemination service, with the target of dealing with 95% of requests for documents within 48 hours.
Gestionar el servicio de distribución de documentos, con el objetivo de gestionar el 95% de las solicitudes de documentos en un plazo de 48 horas.
The number of requests is expected to rise from 3 200 in 2001 to 4 000 in 2002, despite the increase in availability of documents on the web site.
Se espera que el número de solicitudes pase de 3.200 en 2001 a 4.000 en 2002, a pesar del aumento de la disponibilidad de documentos en el sitio web.
The Sector is responsible for ensuring efficient support for EMEA meetings by providing the best possible facilities and services and constantly improving the resources available, as well as assisting delegates with logistics and practical arrangements.
37/ 63 5.3 Servicios de organización de reuniones y conferencias Este Sector es responsable de asegurar un apoyo eficiente a las reuniones de la EMEA, poniendo a su disposición las mejores instalaciones y servicios posibles y mejorando constantemente los recursos disponibles, así como ayudando a los delegados con servicios logísticos y administrativos.
Develop new forms of meetings, particularly in view of the increase in number of meetings held at the EMEA and the future enlargement of the European Union Complete implementation of the computerised meetings management system.
Desarrollar nuevas formas de reuniones, sobre todo a la vista del aumento del número de reuniones celebradas en la EMEA y de la futura ampliación de la Unión Europea Completar la puesta en marcha del sistema informatizado de gestión de reuniones.
Review procedures for reimbursement of delegates to assist with the expected increase in number of delegates Support operation of the Pan-European Regulatory Forum (PERF), particularly with the provision of documentation, technical reports and conference proceedings Implement videoconferencing capacities to improve and maximise the participation by experts in the work of the scientific committees, working parties and mutual recognition facilitation groups
Poner en marcha la realización de videoconferencias para mejorar y maximizar la participación de expertos en el trabajo de los comités científicos, grupos de trabajo y grupos de facilitación del reconocimiento mutuo
Number of meetings and reimbursed delegates 2000-2002
Número de reuniones y delegados a los que se reembolsaron gastos, 2000-2002
Number of delegates
Número de delegados
The rise in number of reimbursed delegates in 2002 will come from an increased number of ad hoc meetings related to the evaluation of medicinal products for human use, increased use of experts in the designation process for orphan medicines and also from preparation and implementation of a number of special projects, in particular relating to the Agency’ s future role in the Community pharmaceuticals regulatory IT strategy.
En 2002 el aumento del número de delegados remunerados se deberá al aumento del número de reuniones ad hoc relacionadas con la evaluación de medicamentos de uso humano, al aumento de la participación de expertos en el proceso de designación de fármacos huérfanos y también en la preparación y aplicación de algunos proyectos especiales, en concreto relacionados con el futuro papel de la Agencia en la estrategia de regulación de la TI farmacéutica en la Comunidad.
The Sector has been set up in order to provide a single point within the Unit for Communications and networking to coordinate and manage individual projects whose objectives are aligned with those of the Unit.
38/ 63 5.4 Gestión de proyectos Este Sector ha sido creado para disponer de un único punto en el seno de la Unidad de Comunicaciones y redes que permita coordinar y gestionar los proyectos individuales cuyos objetivos coincidan con los de la Unidad.
These objectives may be summarised as the facilitation of communications within the European regulatory network, focusing on the communication tools, IT systems and logistical support required.
Estos objetivos se pueden resumir en la facilitación de la comunicaciones en el seno de la Red Europea de Regulación, centrada en las herramientas de comunicación, los sistemas de TI y el apoyo logístico necesario.
The overall objectives for 2002 will be to structure and proceed with the projects, both new and old, for which it will have responsibility.
Los objetivos globales para 2002 se estructurarán y llevarán a cabo con los proyectos nuevos y antiguos en los que tenga responsabilidad.
The Sector will manage both internal EMEA projects and Europe-wide projects as part of the European network.
El Sector gestionará proyector internos de la EMEA y otros de ámbito europeo, como parte de la Red Europea.
These projects include:
Entre estos proyectos se incluye:
Management and organisation of the Pan-European Regulatory Forum Implementation of the electronic Common Technical Document (eCTD) format for submission of applications for marketing authorisations Implementation of the product information management project (PIM).
Gestión y organización del Foro Paneuropeo de Regulación Puesta en marcha del formato del Documento Técnico Común electrónico (DTCe) para el envío de solicitudes de autorizaciones de comercialización Puesta en marcha del proyecto de gestión de la información sobre los productos (PIM).
This is a project to define an exchange standard for the electronic submission of product information included in the summary of product characteristics, the patient information leaflet and product packaging Implementation of the EudraVigilance system Implementation of an EMEA electronic document management system Preparation for the EuroPharm database, a database of information on all products authorised within the EU Development of a clinical trials database
Se trata de un proyecto para definir normas de intercambio para el envío electrónico de la información sobre los productos que aparece en el resumen de características del producto, en el prospecto para el paciente y en el acondicionamiento del producto.
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 5.5 Information technology
Puesta en marcha del sistema EudraVigilance.
 EMEA 2002 Page 38/ 62
Puesta en marcha de un sistema electrónico de gestión de documentos de la EMEA.
The sector’ s mission is to supply reliable and robust information technology (IT) services to the Agency.
39/ 63 5.5 Tecnología de la información La misión del sector es ofrecer servicios fiables y robustos de tecnología de la información (TI) a la Agencia.
These services include appropriate levels of operational support, internal development activities, and technical support for projects with an external focus.
Estos servicios incluyen niveles apropiados de apoyo operativo, actividades de desarrollo interno y soporté técnico para proyectos orientados al exterior.
The EMEA has agreed to take on responsibility for the majority of the pan-European information technology projects and services with effect from January 2003 in accordance with a strategy proposal and implementation plan developed by the European Commission.
La EMEA ha aceptado la responsabilidad de la mayor parte de los proyectos y servicios de tecnología de la información paneuropeos a partir de enero de 2003, de conformidad con una propuesta de estrategia y con el plan de ejecución desarrollado por la Comisión Europea.
This constitutes a major change in the scope of the Agency’ s IT activities with consequences during 2002 (as the Agency puts in place the necessary structures and resources to assume the new responsibilities) and 2003, as the EMEA consolidates the changes effected during 2002 and takes on its new responsibilities in full.
Ello constituye un cambio radical en el ámbito de las actividades de TI de la Agencia, que tendrá consecuencias en 2002 (según la Agencia vaya organizando las estructuras y recursos necesarios para asumir las nuevas responsabilidades) y en 2003, según la EMEA vaya consolidando los cambios efectuados en 2002 y se haga cargo de la integridad de sus nuevas responsabilidades.
Internal services
Servicios internos
During 2002, the IT sector will seek to achieve the following:
En 2002 el Sector de TI intentará lograr los siguientes objetivos:
Function Operational support
Aplicaciones y equipos informáticos
Activity - Ensure a minimum a minimum internal system availability of 98% of IT services during EMEA working hours - Provide helpdesk facilities in accordance with the levels of service required by the Agency
Garantizar una disponibilidad de los servicios de TI internos del 98% como mínimo en horario laboral de la EMEA
Applications & equipment Contribute to the business continuity/ disaster recovery project Equip and connect the 6th floor;
Contribuir al proyecto de continuidad de la actividad/ recuperación de catástrofes
- Execute the replacement of obsolete equipment and applications in accordance with the defined lifecycle criteria
Sustituir los equipos y aplicaciones obsoletos, conforme a los criterios de vida activa definidos
Replace screens; design and implementation of storage area network; contribute to definition of an electronic archiving policy
Sustituir pantallas; diseñar y poner en funcionamiento la red de conservación; contribuir a la definición de una política de archivo electrónico
Development -
Desarrollo
Implement upgrades to customised applications as required by new releases of the underlying proprietary applications
Realizar actualizaciones de las aplicaciones personalizadas, de conformidad con las nuevas normas sobre solicitudes de registro
Personnel database; Sincom 2
Base de datos sobre el personal; Sincom 2
- Develop and implement upgrades to bespoke and customised applications in production at the EMEA in accordance with the priorities defined by EMEA management - Develop or continue the development of new applications in accordance with the priorities defined by EMEA management
Desarrollar e implementar actualizaciones de las aplicaciones alquiladas y personalizadas en producción en la EMEA, de conformidad con las prioridades definidas por los gestores de la EMEA
Scientific memory database; Scientific advice database; Orphan drug database; experts database; ActiTrak Meetings management system
Base de datos científicos; base de datos de asesoramiento científico; base de datos sobre fármacos huérfanos; base de datos de expertos; ActiTrak
Project support and management
-
- Technical support in the development and implementation of major projects
Desarrollar o continuar el desarrollo de nuevas Sistema de organización de aplicaciones, de conformidad con las prioridades reuniones definidas por los gestores de la EMEA
PIM and the eCTD; SIAMED; electronic document management system
Apoyo y gestión de proyectos
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 European initiatives and activities
Apoyo técnico al desarrollo e implementación PIM y DTCe; SIAMED; de grandes proyectos sistema electrónico de gestión de documentos
 EMEA 2002 Page 39/ 62
40/ 63 Iniciativas y actividades europeas
The IT sector will undertake the activities set out below in support of the European initiatives and activities
El Sector de TI llevará a cabo las siguientes actividades, en apoyo de las iniciativas y actividades europeas
Initiative EudraNet
Iniciativa EudraNet
Activities - Preparation for the assumption of operational responsibility from January 2003 - Chair of the EudraNet Telematics Implementation Group
Actividades - Preparación para asumir la responsabilidad operativa a partir de enero de 2003 - Presidir el grupo de aplicación telemática EudraNet
- Operational support to ensure 99% system availability - Management and support of development contractors for the implementation of phases 2 and 3 of the project, including the electronic gateway - Coordination of the testing pilot group including participants from Member States and industry - Chair of the EudraVigilance Telematics Implementation Group
- Apoyo operativo para garantizar una disponibilidad del sistema del 99% - Gestión y apoyo de contratos de desarrollo para la puesta en marcha de las fases 2 y 3 del proyecto, incluida la puerta electrónica - Coordinación del grupo piloto de evaluación, incluyendo a los participantes de los Estados miembros y de la industria - Presidir el grupo de implementación telemática de EudraVigilance
EuroPharm database
Base de datos EuroPharm
- Technical assistance in the specification of the data model and user requirements - Technical assistance in ensuring appropriate compatibility of data field definitions across all pan-European projects - Technical assistance with the trial implementation of the database in conjunction with the nominated developer
- Apoyo técnico en la especificación del modelo de datos y de los requisitos de usuario - Apoyo técnico para garantizar la compatibilidad de las definiciones de los campos de datos en todos los proyectos paneuropeos - Apoyo técnico para la implementación de la base de datos, junto con el organismo encargado de desarrollarla
Electronic submission
Transmisión electrónica
- Technical assistance and support in setting up the necessary systems to receive electronic submissions in accordance with the eCTD - Technical assistance and support in the definition and implementation of the applications necessary to manage data that has been electronically submitted - Technical assistance and support in the definition and implementation of the applications necessary to work with data that has been electronically submitted
- Apoyo técnico y soporte para establecer los servicios necesarios para recibir solicitudes electrónicas, de conformidad con el DTCe - Apoyo técnico y soporte para la definición e implementación de las aplicaciones necesarias para la gestión de datos enviados por medios electrónicos - Apoyo técnico y soporte para la definición e implementación de las aplicaciones necesarias para trabajar con los datos enviados por medios electrónicos
 EMEA 2002 Page 40/ 62
41/ 63 Anexos
EMEA establishment plan 2000 – 2002
Plan de recursos humanos de la EMEA 2000 – 2002
EMEA budget summaries 2000 – 2002
Resúmenes de los presupuestos de la EMEA 2000 – 2002
EMEA contact points and reference documents
Puntos de contacto y documentos de referencia de la EMEA
Profiles of EMEA personalities
Perfil de los directivos de la EMEA
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 1 EMEA establishment plan 2000 – 2002
42/ 63 Anexo 1 Plan de recursos humanos de la EMEA 2000 – 2002
Category and Grade
Categoría y Grado
Occupied as at 31.12.2000
Cubiertos a fecha de 31.12.2000
Authorised for Occupied as at 2001 31.12.2001
Autorizados para Cubiertos a fecha 2001 de 31.12.2001
Authorised for 2002
Autorizados para 2002
A4 A5 A6 A7 A8 TOTAL A B1 B2 B3 B4 B5 TOTAL B C1 C2 C3 C4 C5 TOTAL C D1 D2 D3 D4 TOTAL D
TOTAL A B1 B2 B3 B4 B5 TOTAL B C1 C2 C3 C4 C5 TOTAL C D1 D2 D3 D4 TOTAL D
TOTAL POSTS
TOTAL PUESTOS
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Allocation of posts
43/ 63 Distribución de puestos
Directorate total
Total en Dirección
Head of Unit team Sector for Personnel and budget Sector for Infrastructure services Sector for Accounting Reserve posts
Equipo del Jefe de Unidad Sector de personal y presupuesto
Unit total
Total Unidad
2 10 17 6 2
17 6 2
2 11 19 7 --
19 7 --
Unit for the Pre-authorisation Evaluation of Medicines for Human Use Head of Unit team
Unidad para la Evaluación de Medicamentos de Uso Humano Antes de su Autorización Equipo del Jefe de Unidad
Sector for Scientific advice and orphan drugs Sector for Quality of medicines Sector for Safety and efficacy of medicines Reserve posts
Sector de asesoramiento científico y medicamentos huérfanos
12 19 16 --
12
14 21 19 1
21 19 1
Unit for the Post-authorisation Evaluation of Medicines for Human Use Head of Unit team
Unidad para la Evaluación de Medicamentos de Uso Humano Después de su Autorización Equipo del Jefe de Unidad
Sector for Regulatory affairs and organisational support
Sector de asuntos reglamentarios y servicios de apoyo Sector de farmacovigilancia y seguridad y eficacia de
Sector for Pharmacovigilance and post-authorisation safety and efficacy of medicines
medicamentos ya autorizados
Reserve posts Unit total Unit for Veterinary Medicines and Inspections
Puestos en reserva Total Unidad Unidad para medicamentos e inspecciones en Veterinaria
Head of Unit team Sector for Veterinary marketing authorisation procedures
Equipo del Jefe de Unidad Sector de procedimientos para la autorización de
4 10
10
Sector for Safety of veterinary medicines Sector for Inspections Reserve posts Unit total Communication and Networking Unit
Sector de seguridad de medicamentos veterinarios Sector de inspecciones Puestos en reserva Total Unidad Unidad de comunicación y redes
Head of Unit team Sector for Document management and publishing Sector for Meeting management and conferences Sector for Project management Sector for Information technology Reserve posts Unit total Additional posts in general reserve Total number of posts
Equipo del Jefe de Unidad Sector de gestión y publicación de documentos Sector de organización de reuniones y conferencias Sector de gestión de proyectos Sector de tecnología de la información Puestos en reserva Total Unidad Otros puestos en reserva general Número total de puestos
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 2 EMEA budget summaries 2000 – 2002
44/ 63 Anexo 2 Resúmenes de los presupuestos de la EMEA 2000 – 2002
The summarised comparative budget statements for 2000 to 2002 are as follows:
Los presupuestos comparativos resumidos para los años 2000 - 2002 son los siguientes:
Fees General EU contribution Special EU orphan medicinal
Tasas Contribución general de la UE Subvención especial de la Comunidad Europea para
154 000 200 000
39 154 000 13 200 000
70.82% 23.88%
70,82% 23,88%
69.49% 22.32%
69,49% 22,32%
69.46% 19.84%
69,46% 19,84%
product contribution Contribution from EEA Contribution from EU
medicamentos huérfanos Contribución de la EEA Contribución de programas de la
000 000 245 220
1 000 000 245 220
1.81% 0.44%
1,81% 0,44%
4.68% 0.44%
4,68% 0,44%
programmes (PERF)
UE (PERF) Otras
471 000
217 000 1 471 000
2.66%
0,39% 2,66%
193 000
314 360 193 000
3.33%
3,51% 3,33%
305 000
632 000 305 000
3.27%
2,31% 3,27%
866 000 100.00%
866 000 100,00%
Expenditure Staff
Gastos Personal
Salaries Interim and other support persons Other staff-related expenditure Total title 1 Building/ equipment
Sueldos Personal intermedio y otro
493 000 058 000 350 000 901 000
18 493 000
33.45% 1.91% 2.44% 39.80%
33,45%
20 1 1 23
20
615 000 31.30% 414 000 2.15% 683 640 2.56% 712 640 36.00%
615 000 31,30%
24 1 1 28
24
35.37% 2.70% 2.52% 40.59%
2,52% 40,59%
Rent/ charges Expenditure on data processing Other capital expenditure Postage and communications
Alquiler/ gastos Gastos en procesado de datos Otros gastos de inversión Correos y comunicaciones
9.43% 4.38% 4.26% 0.87%
9,43% 4,38% 4,26% 0,87%
149 000 7.82% 293 000 6.52% 658 000 2.52% 617 000 0.94%
149 000 7,82% 293 000 6,52% 658 000 2,52% 617 000 0,94%
8.41% 3.64% 1.66% 0.56%
8,41% 3,64% 1,66% 0,56%
Other administrative expenditure Total title 2 Operational expenditure
Otros gastos administrativos Total del título 2 Gastos de explotación
2.88% 21.82%
2,88% 21,82%
829 000 2.78% 546 000 20.57%
829 000 2,78% 546 000 20,57%
2.73% 17.00%
2,73% 17,00%
Meetings Evaluations Translation Studies and consultants Publications
Reuniones Evaluaciones Traducción Estudios y consultores Publicaciones
5.92% 33.79% 0.00% 0.01% 0.27%
5,92% 33,79% 0,00% 0,01% 0,27%
110 000 6.24% 308 000 32.35% 428 000 0.65% 225 000 0.34% 190 000 0.29%
110 000 6,24% 308 000 32,35% 428 000 0,65% 225 000 0,34% 190 000 0,29%
6.12% 33.07% 0.51% 0.12% 0.27%
6,12% 33,07% 0,51% 0,12% 0,27%
EU programmes
Programas de la UE Total del título 3
0.39%
0,39% 40,38%
2
2 28
607 360 43.43%
346 360 8,20% 607 360 43,43%
29
1 29
919 000
632 000 919 000
42.41%
2,31% 42,41%
Notes
Notas
(1) Final appropriations for the 2000.
(1) Asignaciones finales para 2000.
(2) Final appropriations for 2001.
(2) Asignaciones finales para 2001.
(3) Budget for 2002 as adopted by the Management Board on 18.12.2001.
(3) Presupuesto para 2002 adoptado por el Consejo de Administración el 18.12.2001.
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 3 EMEA guidelines for 2002
45/ 63 Anexo 3 Directrices de la EMEA para 2002
The following documents are intended to be finalised or released for consultation in 2002.
En 2002 está previsto ultimar los siguientes documentos, o publicarlos para consulta.
Document title Revision of Note for guidance on minimising the risks of TSE transmission via medicinal products CPMP recommendations on vCJD and plasma derived medicinal products – CPMP recommendations on transmissible agents and urinary derived medicinal products Note for guidance on the use of bovine serum used in the manufacture of human biological medicinal products Note for guidance on the production and quality control of animal immunoglobins and immunosera for human use Cell culture inactivated influenza vaccines – Annex to Note for guidance on harmonisation of requirements for influenza vaccines EU recommendations for the influenza vaccine composition for the season 2002/ 2003 Plasma master file:
Título del documento Revision of Note for guidance on minimising the risks of TSE transmission via medicinal products CPMP recommendations on vCJD and plasma derived medicinal products – CPMP recommendations on transmissible agents and urinary derived medicinal products Note for guidance on the use of bovine serum used in the manufacture of human biological medicinal products Note for guidance on the production and quality control of animal immunoglobins and immunosera for human use Cell culture inactivated influenza vaccines – Annex to Note for guidance on harmonisation of requirements for influenza vaccines EU recommendations for the influenza vaccine composition for the season 2002/ 2003 Plasma master file:
CPMP Blood Products Working Party
Grupo de trabajo del CPMP “ Hemoderivados”
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:
Título del documento 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 tick-borne encephalitis immunoglobulin i. m.
Human tick-borne encephalitis immunoglobulin i. m.
Core summary of product characteristics for Hepatitis B immunoglobulin Revision of core summary of product characteristics for human normal immunoglobulin for intravenous use – addition of indication for treatment of parvovirus B19 infection Revision of core summary of product characteristics for human plasma derived factor VII products and human plasma prothrombin complex Revision of core summary of product characteristics for factor VIII inhibitor bypassing fraction Warning on transmissible agents for patient leaflets and summary of product characteristics Revision of core summary of product characteristics for human anti-D immunoglobulin for intravenous and/ or intramuscular use (CPMP/ BPWG/ 574/ 99)
Core summary of product characteristics for Hepatitis B immunoglobulin Revision of core summary of product characteristics for human normal immunoglobulin for intravenous use – addition of indication for treatment of parvovirus B19 infection Revision of core summary of product characteristics for human plasma derived factor VII products and human plasma prothrombin complex Revision of core summary of product characteristics for factor VIII inhibitor bypassing fraction Warning on transmissible agents for patient leaflets and summary of product characteristics Revision of core summary of product characteristics for human anti-D immunoglobulin for intravenous and/ or intramuscular use (CPMP/ BPWG/ 574/ 99)
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 CPMP Efficacy Working Party
46/ 63 Grupo de trabajo del CPMP “ Eficacia”
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:
Título del documento 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:
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:
Note for guidance on Pharmacokinetic Studies in man Points to consider on Live attenuated influenza vaccines Guidance on requirements for pharmaceutical/ clinical documentation for Cell culture influenza vaccines Points to consider on xenogeneic cell therapy Note for guidance on comparability of medicinal products containing biotechnology-derived proteins as active substance Note for guidance on the use of medicinal products during pregnancy: need for post-marketing data Note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling Revision of the Note for guidance on harmonisation of requirements for influenza vaccines
Note for guidance on Pharmacokinetic Studies in man Points to consider on Live attenuated influenza vaccines Guidance on requirements for pharmaceutical/ clinical documentation for Cell culture influenza vaccines Points to consider on xenogeneic cell therapy Note for guidance on comparability of medicinal products containing biotechnology-derived proteins as active substance Note for guidance on the use of medicinal products during pregnancy: need for post-marketing data Note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling Revision of the Note for guidance on harmonisation of requirements for influenza vaccines
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 CPMP Safety Working Party
47/ 63 Grupo de trabajo del CPMP “ Seguridad”
Document title Revision of Note for guidance on carcinogenic potential (3BS7a, Volume 3B, 1998, p.
Título del documento Revision of Note for guidance on carcinogenic potential (3BS7a, Volume 3B, 1998, p.
63) Note for guidance on photosafety testing Points to consider document on the need for assessment of reproductive toxicity of human insulin analogues Discussion paper on environmental risk assessments of non-GMO containing medicinal products for human use Non-clinical documentation of medicinal products with ‘ well-established use’ Note for guidance on the need for non-clinical testing of pharmaceuticals in juvenile animals Discussion paper on the non-clinical safety studies to support single low dose clinical screening studies in man Note for guidance on specification limits for residues for heavy metal catalysts in medicinal products Points to consider on xenogeneic cell therapy Note for guidance on comparability of biotechnology products pre-clinical and clinical issues
63) Note for guidance on photosafety testing Points to consider document on the need for assessment of reproductive toxicity of human insulin analogues Discussion paper on environmental risk assessments of non-GMO containing medicinal products for human use Non-clinical documentation of medicinal products with ‘ well-established use’ Note for guidance on the need for non-clinical testing of pharmaceuticals in juvenile animals Discussion paper on the non-clinical safety studies to support single low dose clinical screening studies in man Note for guidance on specification limits for residues for heavy metal catalysts in medicinal products Points to consider on xenogeneic cell therapy Note for guidance on comparability of biotechnology products pre-clinical and clinical issues Points to consider on the assessment of the potential for QT interval prolongation by non-cardiovascular medicinal products Note for guidance on risk assessment of medicinal products on human reproductive and development toxicities: from data to labelling
CVMP Efficacy Working Party
Grupo de trabajo del CVMP “ Eficacia”
Document title Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy
Título del documento Antimicrobials for veterinary use Summary of product characteristics for antimicrobial products Ectoparasiticide guidance for sheep, cattle and goats Fluid therapy
CPMP Pharmacovigilance Working Party
Grupo de trabajo del CPMP “ Farmacovigilancia”
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:
Título del documento Revision of Note for guidance on the conduct of pharmacovigilance for centrally authorised products Revision of crisis management plan regarding centrally authorised products for human use Guidance document for the implementation of the position paper on compliance with pharmacovigilance regulatory obligations Contribution to Note for guidance on the use of medicinal products during pregnancy:
CVMP Immunologicals Working Party
Grupo de trabajo del CVMP “ Medicamentos inmunológicos veterinarios”
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:
Título del documento Harmonisation requirements for low and high potency and batch consistency of vaccines Harmonisation requirements for low and high potency and batch consistency of vectored vaccines Requirements and controls applied to bovine serum used in the production of immunological veterinary medicinal products Revision: transmissible spongiform encephalopathy Revision: compliance with the European Pharmacopoeia Revision: equine influenza Revision: claims for veterinary vaccines VICH:
 EMEA 2002 Page 47/ 62
48/ 63 Grupo de trabajo del CVMP “ Farmacovigilancia”
Document title VICH:
Título del documento VICH:
CVMP Safety Working Party
Grupo de trabajo del CVMP “ Seguridad”
Document title Safety evaluation of antimicrobial substances regarding the effects on human gut flora VICH:
Título del documento Safety evaluation of antimicrobial substances regarding the effects on human gut flora VICH:
Document title In-use stability testing of veterinary medicinal products Use of near infrared spectroscopy by the pharmaceutical industry Modified release oral and transdermal dosage forms Revision:
Título del documento 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:
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 4 EMEA contact points
49/ 63 Anexo 4 Puntos de contacto con la EMEA
Pharmacovigilance and product defect reporting
Farmacovigilancia e informes sobre productos defectuosos
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.
La vigilancia constante de la seguridad de los medicamentos una vez concedida la autorización de comercialización (“ farmacovigilancia”) constituye una parte importante del trabajo de las autoridades nacionales competentes y de la EMEA.
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.
La EMEA recibe informes sobre seguridad de dentro y fuera de la UE con respecto a los medicamentos autorizados por el procedimiento centralizado y coordina las actividades referentes a la seguridad y calidad de los medicamentos.
For matters relating to pharmacovigilance for medicinal products for human use
Para asuntos relativos a la farmacovigilancia de medicamentos de uso humano
Noël WATHION Direct telephone (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eu. int
Noël WATHION Teléfono directo (44-20) 74 18 85 92 E-mail: noel. wathion@emea. eu. int
For matters relating to pharmacovigilance for medicinal products for veterinary use
Para asuntos relativos a la farmacovigilancia de Medicamentos de uso veterinario
Barbara FREISCHEM Direct telephone (44-20) 74 18 85 81 E-mail: barbara. freischem@emea. eu. int
Medicamentos de uso veterinario Teléfono directo (44-20) 74 18 85 81 E-mail: barbara. freischem@emea. eu. int
For product defect and other quality-related matters
Para asuntos relativos a productos defectuosos y
Francisco PEÑARANDA FERNANDEZ Fax number for defective product rapid alerts (44-20) 74 18 85 90 E-mail: francisco. penaranda@emea. eu. int
Certificados de medicamentos
Certificates of a medicinal product
Certificados de medicamentos
The EMEA issues certificates of a medicinal product in conformity with the arrangements laid down by the World Health Organisation.
La EMEA emite certificados de medicamentos de conformidad con las disposiciones establecidas por la Organización Mundial de la Salud.
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.
Estos certificados pueden ser utilizados en apoyo de las solicitudes de autorizaciones de comercialización dentro y fuera de la UE.
For enquiries concerning certificates for centrally authorised medicines for human or veterinary use
Para preguntas relativas a los certificados de medicamentos autorizados para uso humano
Jonna SUNELL-HUET Direct telephone (44-20) 74 18 84 65 E-mail: certificate@emea. eu. int
Jonna SUNELL-HUET Teléfono directo (44-20) 74 18 84 65 E-mail: certificate@emea. eu. int
Documentation services
Servicios de documentación
A wide range of documents has now been published by the EMEA, including press releases, general information documents, annual reports and work programmes.
La EMEA ha publicado un gran número de documentos, entre ellos notas de prensa, documentos con información general, informes anuales y programas de trabajo.
These and other documents are available either on the Internet at http: / /www. emea. eu. int or by writing to:
Estos y otros documentos pueden encontrarse en Internet bajo la dirección http: / /www. emea. eu. int o solicitándolos por escrito a:
Subscription Service European Agency for the Evaluation of Medicinal Products 7 Westferry Circus Canary Wharf UK - London E14 4H
Servicio de Suscripciones Agencia Europea para la Evaluación de Medicamentos 7 Westferry Circus Canary Wharf Londres E14 4HB
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.
50/ 63 Existe un servicio de suscripción para todos los documentos públicos de la EMEA, distribuyéndose dichos documentos en soporte electrónico o papel.
Further information can be obtained from the Iro MAVROPOULOS
Puede obtener más información en la anterior dirección o contactando con
above address or from Direct telephone (44-20) 74 18 85 E-mail: subscriptions@emea. eu. int
Iro MAVROPOULOS Teléfono directo (44-20) 74 18 85 82 E-mail: subscriptions@emea. eu. int
Requests for general information packs should be sent to
Los documentos de información general deben solicitarse a
Amanda BOSWORTH Direct telephone (44-20) 74 18 84 08 E-mail: amanda. bosworth@emea. eu. int
Amanda BOSWORTH Teléfono directo (44-20) 74 18 84 08 E-mail: amanda. bosworth@emea. eu. int
European experts lists
Listas de expertos europeos
The list of European experts is available for examination on request at the EMEA offices.
Las listas de expertos europeos están disponibles para su inspección previa petición a las oficinas de la EMEA.
Human medicines’ experts list
Lista de expertos en medicamentos de uso humano
human_experts@emea. eu. int
human_experts@emea. eu. int
Veterinary medicines ’ experts list
Lista de expertos en medicamentos de uso veterinario
vet_experts@emea. eu. int
vet_experts@emea. eu. int
Inspectors ’ experts list
Lista de expertos inspectores
inspectors_experts@emea. eu. int
inspectors_experts@emea. eu. int
Press office
Oficina de prensa
Press officer
Encargado de la oficina de prensa
Martin HARVEY Direct telephone (44-20) 74 18 84 27 E-mail: martin. harvey@emea. eu. int
Martin HARVEY Teléfono directo (44-20) 74 18 84 27 E-mail: martin. harvey@emea. eu. int
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 Annex 5 Profiles of EMEA personalities
51/ 63 Anexo 5 Perfil de las personalidades de la EMEA
British
Keith Jones, Presidente del Consejo de Administración, nacido el 14 de octubre de 1937, nacionalidad británica
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.
En 1991, fue nombrado Director Ejecutivo de la Agencia de Control de Medicamentos británica y actualmente es el delegado británico en el Comité Farmacéutico y el Comité Regulador Permanente de la UE, y miembro del Comité de Asesoramiento Científico de la UE perteneciente a la Dirección General de Sanidad y Protección de los Consumidores de la Comisión Europea.
German
Gerhard Kothmann, Vicepresidente del Consejo de Administración, nacido el 23 de julio de 1943, nacionalidad alemana
Qualified veterinary surgeon from the University of Hanover.
Licenciado en veterinaria por la Universidad de Hannover.
After a period of general veterinary practice, Dr Kothmann joined the German Federal Research Centre for Animal Virus Diseases in 1970 and the veterinary administrative service for Lower Saxony in 1972.
Kothmann se incorporó al Centro Federal de Investigación de Enfermedades Víricas Animales en 1970 y al servicio administrativo veterinario de la Baja Sajonia en 1972.
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.
En 1990 colaboró en la reconstrucción de los servicios veterinarios de los nuevos länder federales.
Dr Kothmann joined the EMEA Management Board in 1996 and was elected vice-chairman in 2000.
Kothmann se incorporó al Consejo de Administración de la EMEA en 1996 y fue elegido vicepresidente en el año 2000.
Qualified pharmacist from the University of Uppsala Faculty of Pharmacy.
Qualified pharmacist from the University of Uppsala Faculty of Pharmacy.
From 1976 to 1978, lecturer at University of Uppsala.
Entre 1976 y 1978, profesor en la Universidad of Uppsala.
EMEA/ MB/ 049/ 01-EN-Final Work progamme for 2002 EMEA scientific committees
52/ 63 Comités científicos de la EMEA
Belgian
Daniel Brasseur, Presidente del CPMP, nacido el 7 de junio de 1951, nacionalidad belga
From 1976 to 1986 Dr Brasseur worked as a paediatrician at the University Sint Pieter Hospital in Brussels.
Brasseur trabajó como pediatra en el Hospital Universitario Sint Pieter de Bruselas.
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.
En 1986 y 1987 trabajó un corto período de tiempo para la industria farmacéutica, antes de volver al trabajo clínico en el Hospital Universitario Infantil Reina Fabiola de Bruselas como jefe de la unidad de nutrición y farmacodinámica, un puesto que sigue ocupando en la actualidad.
He joined the Pharmaceutical Inspectorate of the Belgian Ministry of Public Health as head of medical assessors in 1997.
Se incorporó al Cuerpo de Inspectores Farmacéuticos del Ministerio de Salud Pública belga como jefe de asesores médicos en 1997.
French
Eric Abadie, Vicepresidente del CPMP, nacido el 14 de julio de 1950, nacionalidad francesa
Qualified medical doctor from the University of Paris.
Doctor en medicina por la Universidad de París.
Post-graduate qualifications in internal medicine, endocrinology, diabetology and cardiology.
Estudios de posgrado en medicina interna, endocrinología, diabetología y cardiología.
He also holds an MBA.
También es máster en administración de empresas.
British
Steve Dean, Presidente del CVMP, nacido el 2 de agosto de 1951, nacionalidad británica
French
Gérard Moulin, Vicepresidente del CVMP, nacido el 18 de octubre de 1958, nacionalidad francesa
From 1981 to 1984, Dr Moulin worked in the Bovine Pathology Laboratory in Lyon.
De 1981 a 1984, el Dr.
In 1984, he joined the Veterinary Medicines Laboratory in Fougères where he was assessor and rapporteur for marketing authorisation dossiers.
En 1984 se incorporó al Laboratorio de Medicina Veterinaria de Fougères como asesor y ponente para dosieres de autorización de comercialización.
He was also responsible for a laboratory unit.
También fue responsable de una unidad del laboratorio.
Spanish
53/ 63 Josep Torrent i Farnell, Presidente del COMP, nacido el 2 de mayo de 1954, nacionalidad española
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
Licenciado en farmacia y doctor en medicina y cirugía por la Universidad de Barcelona, además de cursar estudios de posgrado en farmacología y toxicología, salud pública e instituciones europeas.