Ethic Committee for Research with medicinal products (ECRmp) |

Presentation

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.

ECR Composition

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:
  - Dr. Jorge Adeva Alfonso – Medico Oncología
  - Dª Mª Luisa Albelda de la Haza – Licenciada Derecho
  - Sra. Sagrario Alegre Alonso – Coordinadora AECC
  - Dr. Gonzalo Carreño Gómez-Tarrago – Medico Hematología
  - Dra. Eva Mª Carro Díaz – Comisión de Investigación
  - Dra. Mercedes Catalán González – Medico Intensivista
  - Dra. Mar Espino Hernández – Pediatra de Atención Primaria
  - Sra. Mª Pilar Hernández Suarez – Diplomado Universitario en Enfermería.
  - Dª Mª Teresa García Morales – Ing. en Telecomunicaciones (delegada protección de datos).
  - Dra. Ana Jiménez Ubieto – Médico Hematología
  - Dª Cristina Martín-Arriscado Arroba – Licenciada Estadística
  - Sr. Francisco Javier Mazuecos Gómez – Trabajador Social Ayuntamiento Madrid
  - Dr. Julián Palomino Doza – Medico Cardiología
  - Dra. Estela Paz Artal – Medico Inmunología
  - Dª. Montserrat Pilas Pérez – Diplomado Universitario en Enfermería
  - Dra. María del Carmen Riesco Martínez – Medico Oncología
  - Dra. Yolanda Rodríguez Gil – Médico Anatomía Patológica
  - Dr. Roberto Rodríguez Jiménez – Médico Psiquiatría
  - Dr. David Sánchez Guzmán – Médico de Familia (Atención Primaria)
  - Dr. Rafael San Juan Garrido – Médico Microbiología
  - Dra. Raquel Siguín Gómez – Farmacéutica Atención Primaria
  - Dra. Sarahí Elisabeth Valdez Acosta – Farmacóloga Clínica (Secretaria Técnica CEIm)
  - Dra. Raquel Sopeña Sutil – Médico Urología
- Secretaria: Dra. María Ugalde Díez — Doctora en Ciencias Biológicas
Versión: dic-2019

Requirements

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)