Last updated on: 02/08/2013
Name of organisation
1) Department/Research groupCentro de Estudios sobre la Seguridad de los Medicamentos
2) Organisation/affiliationUniversidad de Valladolid
Short Name in the inventoryCESME
Administrative Contact
Title Professor
Last name Carvajal
First name Alfonso
Address line 1Ramón y Cajal 7
Address line 2
Address line 3
CityValladolid
Postcode47005
CountrySpain
Phone number (incl. country code)34-983263021
Alternative phone number
Fax number (incl. country code)34-983254924
Scientific Contact
Title Professor
Last name Carvajal
First name Alfonso
Address line 1Ramón y Cajal 7
Address line 2
Address line 3
CityValladolid
Postcode47005
CountrySpain
Phone number (incl. country code)34-983263021
Alternative phone number
Fax number (incl. country code)34983254924
2. Description
The Centro de Estudios sobre la Seguridad de los Medicamentos (CESME) is an interdisciplinary center of the University of Valladolid (Spain); it is devoted to study utilization and effects of drugs in large numbers of people. The CESME has its origin in the experience and work carried out in the Regional Pharmacovigilance Centre of Castilla y León (Spain) since 1986 onwards; currently, the centre is in charge of the pharmacovigilance activities in this region.
The foundation of the CESME was approved by the University of Valladolid, under the University Reform Act of 1983; this condition allows the CESME contract with public or private entities for carrying out research work and scientific and technical advice; also to provide specialized courses. It is part - along with other investigators - of the Research Group (GIR) of Pharmacogenetics, Cancer Genetics, Genetic polymorphisms and Pharmacoepidemiology, within the University of Valladolid
3. Category
University based
4. Available resources
In houseVia Contacts/Network
5. Therapeutic/disease areas of research in drug safety/risk-benefit performed in the past 5 years
Cardiovascular diseases
Endocrine disorders
Gastrointestinal tract
Immunological products and vaccines
Liver disease
Musculoskeletal and joint diseases
Osteoporosis
Psychiatry
Skin disorders
6. Design of drug safety/risk-benefit studies published in the past 5 years
Cohort Study
Case Control Study
Drug Utilisation
Meta-Analysis
7. Experience in collecting data directly from individual patients/respondents
Number of Studies
Greater than 5
Number of patients/respondents involved in the study(ies)
Between 1500 and 14999
8. Access to data collection resources
Capacity to conduct face-to-face interviews
Yes
In a clinic
Yes
In the community
Yes
Electronic data capture systems
Yes
System used:
different databases
Interactive voice response systems
No
Call centre
No
9. Experience in secondary research and meta-analysis
Yes
10. Work with existing data resources in the past 3 years
Name of data resourceNo. of studies
FEDRA10
VAERS1
THIN1
Hospital Discharge2
VigiBase1
11. Registries established by centre
Drug Registryall type of drugs
Disease Registrydifferent diseases (EUDRAGENE)
12. Experience in collaboration in a study team
Principal Investigator
Collaborating Investigator
13. Current involvement in research networks
Networks registered with ENCePP
EUDRAGENE
Other networks:
Network nameNationalInternationalLink to webpage
14. Interest in research opportunities which are funded
By pharmaceutical companies
By charities
By government
By research councils
By EU funding schemes
15. Interest in contract research only if free to publish results
Yes
16. Selected publications of the last 5 calendar years
ReferenceLink to web-publication
Carvajal A, Ortega S, Del Olmo L, Vidal X, Aguirre C, Ruiz B, Conforti A, Leone R, López-Vazquez P, Figueiras A, Ibáñez L. Selective Serotonin Reuptake Inhibitors and gastrointestinal bleeding: A case-control study. PLoS ONE 2011; 6: e19819http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0019819;jsessionid=159DEED0A774FF0718694F411DBADB88.ambra02
Sainz M, del Pozo JG, Arias LH, Carvajal A. Strontium ranelate may cause
alopecia. BMJ 2009; 338:b1494
Sauzet O, Carvajal A, Escudero A, Molokhia M, Cornelius VR. Illustration of
the Weibull Shape Parameter Signal Detection Tool Using Electronic Healthcare
Record Data. Drug Saf. 2013 May 15. [Epub ahead of print] PubMed PMID: 23673816.
Treceño C, Martín Arias LH, Sáinz M, Salado I, García Ortega P, Velasco V,
Jimeno N, Escudero A, Velasco A, Carvajal A. Trends in the consumption of
attention deficit hyperactivity disorder medications in Castilla y León (Spain):
changes in the consumption pattern following the introduction of extended release
methylphenidate. Pharmacoepidemiol Drug Saf. 2012 Apr;21(4):435-41.
Lucena MI, Molokhia M, Shen Y, Urban TJ, Aithal GP, Andrade RJ, Day CP, Ruiz-Cabello F, Donaldson PT, Stephens C, Pirmohamed M, Romero-Gomez M, Navarro JM, Fontana RJ, Miller M, Groome M, Bondon-Guitton E, Conforti A, Stricker BH, Carvajal A, Ibanez L, Yue QY, Eichelbaum M, Floratos A, Pe'er I, Daly MJ, Goldstein DB, Dillon JF, Nelson MR, Watkins PB, Daly AK; Spanish DILI Registry, EUDRAGENE, DILIN, DILIGEN, and International SAEC. Susceptibility to Amoxicillin-Clavulanate-Induced Liver Injury Is Influenced by Multiple HLA Class I and II Alleles. Gastroenterology 2011l; 141: 338-47.
