English to Spanish: Study on HRT, Estudio sobre THS Detailed field: Medical: Pharmaceuticals
Source text - English September, 2005
Dear Doctor,
AAA and BBB are conducting a cohort study for the long-term surveillance of the safety of women using hormone replacement therapy (HRT). The new product under long-term surveillance is ccccc® containing the novel synthetic progestagen drospirenone (DRSP) combined with estradiol.
Especially after the recently published American and British studies on HRT it will be necessary to evaluate the modern HRT preparations used in Europe for their benefits and potential side effects. You will certainly be aware that there are considerable doubts whether the study population in the American studies are representative for the typical European HRT user. Furthermore, both benefit and adverse effects may become apparent after long-term observation in medical practice only, i.e. they are usually not detected in clinical trials (short-term observation, strongly selected groups). Numerous critical papers in relevant medical journals have addressed these issues. We as physicians need to contribute to clarify the open questions. From our point of view there is no real alternative for the treatment of significant menopausal symptoms.
The protocol for this surveillance study on oral HRT preparations focuses on products that contain new chemical entities. The protocol has been developed by an international scientific board with members from the USA, Canada, France, England, and Japan and has already been published in the internet (www.AAAA.info).
The study (including the follow-up period) will be conducted from 2002 to about 2008 and will include 30,000 women. It was started in Germany, followed by Austria, Italy and starts now in Spain.
About 20,000 women were already included in the study since 2002.
In the course of this study we do not want to influence the individual prescription behaviour of the participating physicians, nor the wishes of the women. We are looking for practices that prescribe ccccc® and that will be able to motivate women to participate in a 3-year study.
What kind of patients can be included in the study?
All your female patients aged 40 years and older and
· who were prescribed an oral HRT preparation first time (both, “starters” of novel products like ccccc® and “starters” of established products are eligible)
· who switched (“Switcher”)the prescription from one oral HRT to another HRT preparation (e.g., switch to ccccc®)
· who re-started the use of an oral HRT preparation. To re-start, she must have been off it at least a month
(“Re-Starter”)
How many patients you will include will be up to your prescription behaviour and to the wishes of your patients.
What will you have to do?
We ask you to identify women who are willing to participate in the long-term surveillance study, i.e. you have to counsel women and informing them on the conditions of participation in a 3-year study of their experiences with HRT drugs. If women are interested to participate, they will be given information material provided for this purpose. Please, enter the preparation prescribed and the blood pressure values on the questionnaire. The woman has to sign an Informed Consent Form and has to be asked to complete a short questionnaire. The consent form and the completed questionnaire will then be sent to CCCC in Madrid by your practice staff.
In the majority of cases no further activity from you or your practice staff is required. If a woman reports significant adverse events in the course of the study, AAAA may wish to phone the physician who treated the reported condition phone concerning the possible medical background.
Please add the kind of special honorarium or incentive for the physicians
What will your patients have to do?
The women give their free consent to participate in this 3-year study and report on adverse events. Before study start they have t sign a consent form and are asked to complete a short questionnaire (ca. 2-5 minutes).
During the three years of follow-up, the participants will receive four more short questionnaires (1 sheet each), with the request to complete and return it in a pre-paid envelope.
You will normally not be contacted, unless questions have to be resolved.
In accordance with the country-specific regulations, approval(s) from the respective ethics committee(s) (or data protection approvals) will be obtained.
Should you have any questions, please contact:
AAAA-
Phone +tttt
BBBB,
Phone +ttttt
We are looking forward to co-operating with you.
Yours sincerely,
AAAA
BBBB
Invitation:
Surveillance Study on Hormone Replacement Therapy during Menopause (mmmm HRT): We Need Your Help and Your Information about Your Well-Being and Your Health for 3 Years
Dear Patient,
We are pleased that you have agreed to take part in our study on hormone replacement therapy. You have just received a prescription of this therapy from your doctor. Your prescribed drug is very efficacious and may have in rare cases undesirable side effect – like all other efficacious pharmaceutical drug. This product has been carefully investigated and was approved for the treatment of menopausal symptoms by the Spanish Health Authority. The available knowledge about the benefits and risk are reflected in the package leaflet. This kind of information is to be checked and complemented by many findings from medical practice.
For this reason, a large investigation was launched in many European countries. Never before has such a large examination, which will involve up to 30,000 women, been conducted in Europe. This long-term study, which includes cccc and other continuous combined HRT drugs, is supported by CCCC and is being conducted by an independent research institution. Your individual use of this kind of medication will not be affected by your participation in this study. You may stop taking the product, interrupt its use, or switch to another HRT drug.
This study will be the first opportunity for women in Spain to report their experience with modern hormone replacement therapy and your participation in the study is important for the benefit of women in Spain, in Europe and in many other countries of the world.
What do we expect from you as a study participant?
We would like to ask you to answer a few questionnaires on your experience with the use of hormone replacement therapy and your general condition over a period of about three years:
- First the enclosed basic questionnaire
- Every six to twelve months a short follow-up questionnaire with some questions on the use of the HRT drug and on diseases/complaints that may possibly have occurred during the respective period. (Please, complete this questionnaire even if you have stopped taking, discontinued intake or switched to a different preparation during that time.)
We will send you the short follow-up questionnaires (4 in total) by mail, returning them will be free of charge for you.
Your participation in this project is, of course, voluntary.
AAAA, AAAA, that conducts this study in co-operation with BBBB, follow the Data Protection Regulations. Please, read also the enclosed “Declaration on Data Protection and Absolute Confidentiality of Your Data”.
Why do we need your address?
We need your address in order to send you the follow-up questionnaires. It will be stored for this purpose in a separate and specially protected file and exclusively used to print the covering letters. Your telephone number would be used, should we have any questions concerning your data given in the questionnaire, or if problems occur with the mail delivery of the questionnaire.
What will be done with your data?
The questionnaires do neither contain your name nor your address, but only a number assigned to your doctor, to which a number for yourself will be added later. The number printed on the follow-up questionnaires will only serve for assigning your data. Further details will be given in the “Declaration on Data Protection and Absolute Confidentiality of Your Data”.
Should you have any further questions concerning the study or the questionnaire, please do not hesitate to contact:
Dr. AAAA Telephone: +ttttt
Prof. BBBB Telephone: +ttttt
CCCC Telephone: +ttttt
Thank you very much for your co-operation.
With best wishes.
Yours sincerely,
AAAA
BBBB
CCCC
Translation - Spanish Septiembre de 2005
Apreciado Doctor,
AAA y BBB están llevando a cabo un estudio de cohortes para vigilar a largo plazo la seguridad de las mujeres en tratamiento con terapia hormonal sustitutiva (THS). El nuevo producto en estudio a largo plazo es ccccc®, que combina el nuevo progestágeno sintético Drospirenona (DRSP), con estradiol.
Especialmente tras la reciente publicación de estudios americanos y británicos sobre THS, se hace necesario evaluar los nuevos preparados de THS empleados en Europa, con el fin de determinar sus beneficios y potenciales efectos colaterales. Seguramente Vd. es consciente de que existen importantes dudas sobre si la población observada en los estudios americanos es representativa de la usuaria tipo de THS en Europa. Además, es posible que en la práctica médica los beneficios y los efectos adversos aparezcan sólo en una observación a largo plazo; p. ej es bastante habitual que no se detecten en ensayos clínicos (tiempo breve de observación, grupos muy seleccionados).
Se han abordado estas cuestiones en numerosos artículos de prestigiosas publicaciones médicas. Es necesario que nosotros, como médicos, ayudemos a clarificar preguntas que están en el aire. Desde nuestro punto de vista no existen verdaderas alternativas para el tratamiento de síntomas menopáusicos significativos.
El protocolo para este estudio de vigilancia de preparados orales para THS se centra en productos que contienen nuevas sustancias químicas. Dicho protocolo ha sido desarrollado por un equipo científico internacional, formado por miembros de EEUU, Canadá, Francia, Inglaterra y Japón, y ya ha sido publicado en Internet. (www.AAAA.info) .
El estudio (incluido el periodo de seguimiento), se llevará a cabo entre 2002 y 2008, en 30.000 mujeres. Comenzó en Alemania, posteriormente en Austria e Italia, y ahora se inicia en España. Desde 2002 se han incluido ya unas 20.000 mujeres.
En el transcurso de este estudio no queremos influir en la prescripción individual de los médicos participantes, como tampoco en los deseos de las mujeres. Buscamos médicos que decidan prescribir cccc, y sean capaces de motivar a las mujeres para participar en un estudio de 3 años.
¿Qué tipo de pacientes pueden ser incluidas en el estudio?
Todas sus pacientes mujeres, con edad igual o superior a 40 años, así como:
-aquéllas a quienes se les haya prescrito THS oral por primera vez (“Starters”); son las pacientes de elección, tanto si inician el tratamiento con productos nuevos como ccccc®, como si lo hacen con productos habituales;
-quienes cambian (“Switcher”) de preparado, esto es de una THS oral a otra (p.ej. cambio a ccccc®);
-quienes reinician un tratamiento (“Re-starter”) con THS oral. Para ser considerado reinicio, el tratamiento debe haber sido suspendido durante, al menos, un mes.
El número de pacientes a incluir dependerá de su criterio de prescripción, así como de los deseos de sus pacientes.
¿Qué tendrá que hacer Vd.?
Le pedimos que identifique a mujeres que deseen participar en el estudio de vigilancia a largo plazo; p.ej. deberá aconsejar a las mujeres e informarlas acerca de las condiciones de participación en un estudio de 3 años, y de las experiencias con fármacos de THS. Aquellas mujeres interesadas en participar, recibirán material informativo, facilitado para tal fin. Por favor, cumplimente en el cuestionario los datos sobre el preparado prescrito, así como las cifras de tensión arterial. La mujer deberá firmar un Consentimiento Informado y responder a un breve cuestionario. Tanto el consentimiento informado como el cuestionario cumplimentado serán remitidos a CCCC en Madrid por su equipo.
En la mayor parte de los casos, Vd. o los miembros de su equipo no deberán hacer nada más. En caso de que alguna mujer refiera efectos adversos significativos durante el estudio, es posible que AAAA desee contactar por teléfono con el facultativo que haya tratado dicho efecto, con el fin de investigar el posible contexto médico.
Por favor, añada el tipo de incentivo u honorario especial para médicos.
¿Qué tendrán que hacer sus pacientes?
Las mujeres darán su libre consentimiento para participar en este estudio de 3 años de duración e informar sobre efectos adversos.
Antes del estudio deberán firmar un consentimiento informado, y cumplimentar un breve cuestionario (de unos 2-5 minutos).
Durante los 3 años de seguimiento, las participantes recibirán otros 4 breves cuestionarios (de una hoja cada uno) con las preguntas que deberán responder y enviar en un sobre prefranqueado.
Normalmente no contactaremos con Vd., salvo que surjan cuestiones por resolver.
Siguiendo la normativa específica de cada país se obtendrá la aprobación de los correspondientes comités éticos (o la aprobación en materia de protección de datos).
Si tiene cualquier duda, por favor, contacte:
Prof. AAAA.
Teléfono + tttttt
Dr. BBBB.
Teléfono + ttttt
Esperamos poder colaborar con Vd.
Atentamente,
AAAA
BBBB
Invitación
Estudio de Vigilancia de Terapia Hormonal Sustitutiva durante la Menopausia (MMMM HRT): Necesitamos Su Ayuda y la Información sobre Su Salud y Bienestar durante 3 Años.
Querida Paciente,
Nos alegra que haya aceptado participar en nuestro estudio sobre terapia hormonal sustitutiva.
Su médico acaba de prescribirle este tratamiento. El fármaco que le ha recetado es muy eficaz y en escasas ocasiones puede presentar efectos colaterales no deseados –como cualquier otro fármaco-. Este producto ha sido cuidadosamente investigado, y cuenta con la aprobación de las Autoridades Sanitarias españolas para el tratamiento de los síntomas en la menopausia. En el prospecto, dentro del envase, dispone de la información sobre los beneficios y riesgos que comporta. Dicha información será revisada y complementada con los hallazgos que surjan de la práctica médica.
Por este motivo se ha puesto en marcha una investigación que incluye a 30.000 mujeres, lo que la convierte en la más amplia investigación europea hasta el momento. Este estudio a largo plazo, que incluye ccccc y otros fármacos de THS combinada continua está respaldado por yyyyyy se lo realiza una institución investigadora independiente. El uso individual que usted hará de este tipo de medicación no se verá influido por su participación en este estudio. Podrá interrumpir el tratamiento, abandonarlo, o cambiar a otro fármaco de THS.
Este estudio supone la primera oportunidad para que las mujeres españolas puedan informar sobre su experiencia con terapia hormonal sustitutiva moderna; su participación en el mismo será importante para beneficiar a las mujeres en España, Europa y muchos otros países del mundo.
¿Qué esperamos de Vd. como participante en el estudio?
Nos gustaría pedirle que responda a algunos cuestionarios sobre su experiencia como usuaria de la terapia hormonal sustitutiva y sobre su estado general, durante un periodo aproximado de 3 años:
-Inicialmente, el cuestionario básico adjunto.
-Cada 6-9 meses, un breve cuestionario de seguimiento con algunas preguntas acerca del uso de fármacos de THS, así como alteraciones/quejas que puedan haber surgido durante el periodo correspondiente. (Por favor, cumplimente este cuestionario incluso si interrumpe el tratamiento, olvida alguna toma, o cambia a otro fármaco diferente durante ese tiempo).
Le enviaremos estos breves cuestionarios (4 en total) por correo. Devolverlos no le costará nada.
Por supuesto, su participación en este proyecto es voluntaria.
AAAA, y BBBB, que llevan a cabo este estudio en colaboración con CCCC, cumplen con la normativa de protección de datos. Por favor, lea también la “Declaración sobre Protección de Datos y Absoluta Confidencialidad de sus Datos” que le adjuntamos.
¿Por qué es preciso que nos facilite su dirección?
Necesitamos su dirección para poder enviarle los Cuestionarios de Seguimiento. La almacenaremos para tal fin en archivos individuales, especialmente protegidos, utilizándola exclusivamente para cumplimentar las cartas.
Haríamos uso de su número de teléfono si surgiesen cuestiones relacionadas con los datos facilitados en el cuestionario, o si hubiese problemas en la entrega postal del cuestionario.
¿Qué sucederá con sus datos?
En los cuestionarios no constará su nombre ni dirección; tan sólo el número asignado a su médico, al que se le añadirá un número para identificarla a Vd. El número impreso en los cuestionarios de seguimiento sólo servirá para asignar sus datos. Dispone de información más detallada en la “Declaración de Protección de Datos y Absoluta confidencialidad de sus Datos”.
Si tiene cualquier duda relacionada con el estudio o el cuestionario, por favor, no dude en contactar:
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NATIONALITY: Spanish
LANGUAGES
Spanish- Native
· English
1. Escuela Oficial de Idiomas (Spanish Official School of Foreign Languages).
2. Advanced Course on English Conversation, Escuela Oficial de Idiomas.60 hours.
3. Course on Technical (Medical) English. 20 hours. Marqués de Valdecilla Hospital. Santander.
· French
1. Escuela Oficial de Idiomas (Spanish Official School of Foreign Languages).
· Italian
1. Self-education.
2. Escuela Oficial de Idiomas (Spanish Official School of Foreign Languages).
· Catalan
1. Consorci per a la Normalització Lingüística de Catalunya (Official School of Catalan, Barcelona).
. I currently study Portuguese
1. Escuela Oficial de Idiomas (Spanish Official School of Foreign Languages).
CONGRESSES
· World Congress of Perinatal Medicine. Interpreter English-Spanish Vall d’Hebron Hospital. Barcelona 2001.
MEDICAL BOOKS
· Translation of Jane Symons' Book "How to have a baby and still live in the real world" (About Pregnancy and Delivery, with accurate medical explanations for pregnant women) into “Cómo tener un bebé y sobrevivir a ello”. Editorial Tuscania. Barcelona. 2003.
* Pharmaceutical studies, marketing support materials, quality control analysis, questionnaires...
* Manuals: LCD clocks, blenders, heaters, electric toothbrushes... for Carrefour brands, L.C. snc, AIDA S.r.l, Wineurope, etc..
* Documents on Electrical devicesfor Cisco, etc.
* Oenology Manuals on Wine Pumps, labelling for a "Ribera de Duero" brand, etc.
* Engineering brochures for Sekon s.r.l, CICA, Arcelor, LA MECCANICA spa, Benton, James Hewitt, Control Moving, etc.
* Documents on Electronic devices for Pepperl+Fuchs.
* Real Estate documents for ADMOVING SA, etc.
* Geotechnical Studies for de Cerenville, etc.
* Automotive oil brochures for Castrol.
* Documents on Ecology for Carbonplanet.
* Fitness Machines Tohyvibe, Luxvibe, etc.
* Books for Women and Children.
* Cosmetics Ecocert (Argan's oil), Pupa cosmetics, Lacoste, etc.
* Advertising Campaigns: Ferrero Rocher, Mon Chéri, Kinder Bueno, Kinder Sports, Kinder Joy, Kinder Pinguì, Kinder Maxi, Kinder Sorpresa, Kinder Sandwich, Kinder Garden, Nutella, McDonalds, Italian pasta, H&M, Lacoste, Coca-Cola, Pupa cosmetics, etc.
Some of the advertising spots I have translated:
* Websites (not the Web itself, but just the translation) for several enterprises: tourism, plastics, hotels, English Courses...
* Geotechnical Studies for a French Townhall, etc.
* Nathalia Brodskaya's book "Impressionism" into "Impresionismo". Colección: Numen. Editorial: AMS (Advanced Marketing Service). 2006.
* Documents about Plastics Manufacture, Press Machines, ....
* Documents on religion: Carmelite Order, etc..
MEDICAL WORK EXPERIENCE
· Nurse in Primary Care Trusts. July 1995 - January 2000. Atención Primaria Santander-Laredo. Santander.
· Nurse in Hospital Wards. Marqués de Valdecilla Hospital. January 2000 - January 2001.
------------------
· Midwifery formation. Vall d’Hebron Hospital, Barcelona. February 2001- February 2003.
· Midwife in Primary Care Trusts (control during the pregnancy, contraception information and family planning, sexual education for High school students, classes for pregnant women (focused on delivery, baby care, postpartum care...), groups targeted to menopausal women. Barcelona, February 2003-November 2003.
· Midwife in Delivery Room. Mataró Hospital. Barcelona. June 2003 - November 2003.
· Midwife in Primary Care Trusts (see contents above).Valladolid, November 2003 - July 2004.
· Midwife in Delivery Room. Clinico and Rio Hortega Hospitals. Valladolid, March 2004 - June 2004.
· Midwife in Delivery Room. Marqués de Valdecilla Hospital. Santander. July 2004 - September 2005.
FURTHER INFORMATION
· Trainer of Syntothermic Method for Natural Family Planning. 45 hours. Acodiplan. Barcelona, 2001.
· Course on “High risk Pregnancies: assessment and control during pregnancy and delivery”. 40 hours. Hospital Clínico Universitario. Sacyl. Valladolid 2006.
· Course on “HPV and Cervical Cancer”. 6 hours. Gerencia de Atención Primaria Valladolid Este. Sacyl. 2006.
· Course on “Gender Violence”
. 30 hours. Cantabrian College of Nurses. Santander. 2005.
· Course on “Nutrition: Anorexia, Bulimia and Obesity”
. Marqués de Valdecilla Hospital. Santander 30 hours. 2005.
· Course on “Pediatrics and Child care”
. 100 hours. Logoss School. 2005.
· Course “Assessment and Development in Childhood”
. 100 hours. Logoss School. 2005.
· Course “Pathologies most suffered by Infants”
. 100 hours. Logoss School. 2005.
· Course “Disorders and Psychopathology in Infants”
. 100 hours. Logoss School. 2005.
· Course “Massage and Nursing”
. 40 hours. Cantabrian College of Nurses. Santander. 2005
· Course “Pediatrics Update”
. 250 hours. Health Service Department in Canary Islands. 2005.
· Course “Bioethics”
. 30 hours. Marqués de Valdecilla Hospital. Santander. 2005.
· Course “Basic Research Methodology”
. 40 hours. Marqués de Valdecilla Hospital. Santander. 2005.
· Course “Primary Care Nursing Approach”
. 20 hours. Cantabrian College of Nurses. Santander. 2005.
· Course “Primary Care for Inmigrants”
200 hours. Health Service Department in Canary Islands. 2005.
· Course “Technical English Language”
. 20 hours. Marqués de Valdecilla Hospital. Santander. 2005.
· Session: “Update in Assisted Reproduction”
. FIValladolid 2004.
· Course “Urinary infection: manage and prevention”
. Spanish Gynaecology Association (SEGO) and cols. 5,5 credits.
· Course “The pelvic floor in Menopause”
. 15 hours. Atención Primaria Valladolid Este. 2003.
· Course "Update on Hormonal Contraception and Intrauterine Devices”
. 4 hours. Catalonian Midwifes Association. Barcelona, 2001.
· Symposium "Donation and Use of the Umbilical Cord Blood”
. 4 hours. La Caixa Foundation. Barcelona, 2001.
· Course “Update: Female Control in Primary Care”
.25 hours. Santander, 1999.
· Course “Stress at Work”
. 20 hours. Cantabrian Government. 1999.
· Course “Update: Emergences in Primary Care”
. 30 hours. Cantabrian Government, 1999.
· Course “Assertiveness: techniques”
. 20 hours. Town Hall of Santander, in association with the Cantabrian College of Nurses. 1998.
· Course “Temperature and Dampness conditions at Work”
. Centre for the Health at Work. Cantabrian Government. 20 hours. Santander, 1998.
· Course “Information and Safety Standards”
. Centre for the Health at Work. Cantabrian Government. 25 hours. Santander, 1998.
· Course “Nursing and Specialised Care”
. Complutense University of Madrid. 125 hours. Health Sciences School. Madrid, 1996.
· Course “Drugs and addictions”
. Cantabrian Government. 20 hours. Santander 1996.
· Course “Clinical and Psychosocial Approach to Old People”
. Canarian Centre for Health Studies. 240 hours. 1995-96.
· Nursing Session "A view to Nursing Specialization"
. Santander, 1995.
· Course “Clinical and Psychosocial Approach in Cancer patients”
Canarian Centre for Health Studies. 240 hours. 1994-95.
· Course “Natural Deliveries"
. (one weekend). Centre for Natural Deliveries Acuario. Beniarbeig, Alicante. June 2002.
· Course “Violence at home: abuse on children, women and old people"
. Vall d’ Hebron Hospital, in association with the Catalonian Society of Psychiatrics. Barcelona. 2002.
· Course “Violence at home: Psychical abuse”
. ". Vall d’ Hebron Hospital, in association with the Catalonian Society of Psychiatrics. Barcelona. 2003.
· Session “An approach to the Haptonomy, the affection Science"
. Vall d’Hebron Hospital. Barcelona. 2001.
· Session "AIDS International Day: experiences in Mataró”
. Mataró Hospital, Barcelona, 2001.
· X Session “Update: Screening and Treatment of preinvasive lesions in cervical Cancer”
. 6 hours. Town Hall of Mollet del Vallés, Barcelona, 2001.
· III Session "Drugs and another forms of abuse"
. Town Hall of Madrid. 10 hours 1997.
SPEECHES
· “Menopause Care Program”
, Unidad Docente de Matronas de Cataluña. (Catalonian School of Midwives). 2002.
SESSION, ORGANIZER
· Session "School and Healthy hearts"
(session targeted to 6 to 12-year-old children); in association with the Marqués de Valdecilla Hospital, Santander. 1998.
COURSES ON TEACHING
· Course “Teaching the teachers”
. 400 hours. University of Vigo, 2003.
· CAP (Course to become Teacher in High School), Hospitalary Processes
. University of Cantabria. 2005.
TEACHER
· “Update on Familiar Planning. New Methods”
. Targeted to General Practitioners and Nurses. 2 hours. Delicias I Primary Care Trust. Valladolid. 2004.
· “Contraception and Sexuality in Adolescence”
. 4 hours. For students (teenagers). Lestonnac High School. Valladolid. 2004.
· “Contraception and Sexuality in Adolescence”
. 4 hours. For students (teenagers). Lestonnac High School. Valladolid. 2005.
MUSICAL EDUCATION
· Solfa from 1st to 4th course. Conservatory of Valladolid. 1986-1990
· Choir formation. Conservatory of Valladolid. 1991.
· Piano. 3 years. Conservatory of Valladolid. 1991-1993.
DRIVING LICENCE
Since 1996.
OENOLOGY/WINE TASTING
several courses (in Spain and Italy)
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