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Ethic Committee for Research with medicinal products (ECRmp)

 

On 13 January 2016, the new Royal Decree 1090/2015 came into effect, regulating clinical trials with drugs, the Research Ethics Committees with medicines and the Spanish Registry of Clinical Studies. This royal decree seeks to adapt Spanish legislation to make viable the current and future application of Regulation (EU) No. 536/2014 and to develop those aspects that the regulation leaves to national legislation, including the Ethic Committee for Research with medicinal products. Several aspects are introduced that involve a novelty with respect to the Committees, starting with the denomination itself as the Research Ethics Committees with medicinal products (ECR). In addition, it is worth highlighting the recognition of the integration of the ECR in the development of the Law 14/2007, of 3 July on biomedical research.

All the documentation referring to this new legislation is posted on the website of the Spanish Agency for Medicines and Medical Devices.

 

ECRmp Composition (Spanish)
  • Presidenta: Dra. Mª del Puy Goyache Goñi — Farmacéutico Adjunto de Farmacia Hospitalaria
  • Vicepresidente: Dr. Luis Manuel Manso Sánchez— Adjunto de Oncología
  • Vocales:
    • Sra. Mª Luisa Albelda de la Haza — Licenciada en Derecho
    • Dra. Mª de las Mercedes Catalán González — Médico Medicina Intensiva
    • Dr. Eduardo Gutiérrez Martínez — Médico Nefrología
    • Sra. Mª Pilar Hernández Suárez – Diplomada Universitaria en Enfermería (Comité Ético Asistencial)
    • Dra. Ana Jiménez Ubieto – Medico de Hematología y Hemoterapia
    • Sr. Francisco Javier Mazuecos Gómez — Trabajador Social Ayuntamiento de Madrid
    • Dr. César Minué Lorenzo — Médico de Familia del Servicio Madrileño de Salud
    • Sra. Montserrat Pilas Pérez — Diplomada Universitaria en Enfermería
    • Dra. María del Carmen Riesco Martínez — Medico Oncología
    • Dra. Yolanda Rodríguez Gil — Médico Anatomía Patológica
    • Dr. Roberto Rodríguez Jiménez — Médico Psiquiatría
    • Dra. Sarahí Elizabeth Valdez Acosta — Farmacóloga clínica (Secretaria Técnica del CEIm)
    • Dra. Raquel Siguín Gómez — Farmacéutica Atención Primaria
    • Sra. Sagrario Alegre Alonso – Coordinadora AECC
    • Dra. Mª Mar Espino Hernández – Nefrología Pediátrica
    • Dr. Julián Palomino Doza – Médico Cardiología
    • Dr. Rafael San Juan Garrido – Médico Microbiología
    • Dra. Eva Carro Díaz – Comisión de Investigación
    • Sra. Cristina Martín-Arriscado Arroba – Licenciada en Estadística
    • Dra. Estela Paz Artal – Médico Inmunología
  • Secretaria: Dra. María Ugalde Díez — Doctora en Ciencias Biológicas

 

Versión: feb-2018

 

  • Requirements for conducting clinical trials with medicinal products (Document)
  • Requirements for conducting clinical research with a medical device (Document)
  • Requirements for requesting the evaluation of a relevant clinical trial modification (Document)
  • Requirements for the studies follow-up to be submitted by the sponsor to CEIm (Document)
  • Requirements for carrying out post-authorisation studies (PASs) with medicinal products (Document)
  • Requirements for conducting Research Projects (Document)

 

 

For the download of the documentation templates related to clinical trials, you should go to the website of the Spanish Medicines Agency.

 

 

Technical staff and scientific support

María Ugalde Díez. Tlf. 91 779 26 13
e-mail: mugalde.imas12@h12o.es

Sarahi Valdez Acosta. Tlf. 91 779 26 14
e-mail: stecnicacei@h12o.es

Documentation management’s Administrative staff

Clinical trials: Paloma Fernández Cruz.  Tlf. 91 779 26 15
e-mail: ceic@h12o.es

Projects and EPAs: Paloma Fernández Cruz. Tlf. 91 779 26 16
e-mail: ceic@h12o.es