Good Clinical Practice (GCP) Guidelines (2025)
Objective:
The overall objective of the course is to train participants in clinical trials on the various aspects of GCP, based on the ICH E6 (R3) document on Good Clinical Practice (International Conference on Harmonization). In addition, it aims to train and update researchers on current regulations in Spain and on the ethical aspects related to conducting clinical trials.
Specific objectives:
- To gain a deeper understanding of the ethical and legal aspects of clinical research involving drugs and/or medical devices.
- Gain a deeper understanding of the Guidelines for Good Clinical Practice
- To deepen understanding of informed consent in health research
- To gain a deeper understanding of the responsibilities of the parties involved in clinical research.
- To gain a deeper understanding of the role of the CEI in clinical research.
- Gain a deeper understanding of the essential EC documentation.
- Reinforce the concepts of pharmacovigilance and applicable regulations in clinical trials.
- To develop the general principles of Good Clinical Practice in Advanced Therapies.
- Gain a Deeper Understanding of EECC Audits and Inspections
- Raise awareness of the importance of the Data Collection Workbook in EECC.
Date:
It will be available from December 9 to 16, 2025, through the IBSAL platform.
Location:
Online. IBSAL Platform
Speakers:
- Ms. Carmen Arias De La Fuente.
Ph.D. in Molecular Biology. Head of the Clinical Trials Division at the IBSAL Management Unit.
- Ms. Esperanza López Franco.
Ph.D. in Molecular Microbiology and Genetics. Administrator and CRA at UICEC IBSAL/SCReN.
- Mr. Ricardo López Pérez.
Ph.D. in Biochemistry. Manager and CRA at UICEC IBSAL/SCReN.
- Ms. Maria Concepcion Turrión Gómez.
Ph.D. in Pharmacy and Biochemistry. Technical Secretary of the CEIm for the Salamanca Health District.
- Mr. José V. Hernández Madrid.
Bachelor of Science in Pharmacy. Study Coordinator/Data Manager in the Clinical Trials Department at IBSAL.
- Ms. Cristina Lugones Sánchez.
Ph.D. in Nursing. Researcher at IBSAL and APISAL
- Ms. María Fátima Macho Sánchez-Simón.
Bachelor of Veterinary Medicine, Ph.D. in Neuroscience, Research Associate at the UICEC’s SCReN at IBSAL.
Program:
ANNOUCEMENT_Schedule for the 2025 Course on Good Clinical Practice (GCP)
Enrollment:
REGISTRATION:
(NOTE: HUS personnel not affiliated to IBSAL are advised to register through the GESTION@ training application).
The pre-registration deadline is Friday, December 5, 2025. Please register individually through our website:
In order to successfully complete the course and receive the relevant certificate, it is necessary to complete 80% of the total program.
Please note that you will only be considered enrolled in the course once you receive the confirmation email, as there is a limit of 40 spots.
Method of selection:
Enrollment in the course will be carried out in strict order of enrollment (in courses with high demand, preference will be given to IBSAL personnel), according to the agreement of the IBSAL Training Commission.