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X-WR-CALDESC:Events for IBSAL
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DTSTART:20240101T000000
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DTSTART;VALUE=DATE:20251209
DTEND;VALUE=DATE:20251217
DTSTAMP:20251027T071137Z
CREATED:20251027T071137Z
LAST-MODIFIED:20251027T071137Z
UID:25293-1765238400-1765929599@ibsal.es
SUMMARY:Good Clinical Practice (GCP) Guidelines (2025)
DESCRIPTION:Good Clinical Practice (GCP) Guidelines (2025) \nObjective: \nThe 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.  \n  \nSpecific objectives: \n\nTo gain a deeper understanding of the ethical and legal aspects of clinical research involving drugs and/or medical devices.\nGain a deeper understanding of the Guidelines for Good Clinical Practice\nTo deepen understanding of informed consent in health research\nTo gain a deeper understanding of the responsibilities of the parties involved in clinical research.\nTo gain a deeper understanding of the role of the CEI in clinical research.\nGain a deeper understanding of the essential EC documentation.\nReinforce the concepts of pharmacovigilance and applicable regulations in clinical trials.\nTo develop the general principles of Good Clinical Practice in Advanced Therapies.\nGain a Deeper Understanding of EECC Audits and Inspections\nRaise awareness of the importance of the Data Collection Workbook in EECC.\n\n  \nDate: \nIt will be available from December 9 to 16\, 2025\, through the IBSAL platform. \n  \nLocation: \nOnline. IBSAL Platform  \n  \nSpeakers: \n\nMs. Carmen Arias De La Fuente. \n\nPh.D. in Molecular Biology. Head of the Clinical Trials Division at the IBSAL Management Unit.  \n\nMs. Esperanza López Franco. \n\nPh.D. in Molecular Microbiology and Genetics. Administrator and CRA at UICEC IBSAL/SCReN.  \n\nMr. Ricardo López Pérez.\n\nPh.D. in Biochemistry. Manager and CRA at UICEC IBSAL/SCReN.  \n\nMs. Maria Concepcion Turrión Gómez.   \n\nPh.D. in Pharmacy and Biochemistry. Technical Secretary of the CEIm for the Salamanca Health District.  \n\nMr. José V. Hernández Madrid.\n\nBachelor of Science in Pharmacy. Study Coordinator/Data Manager in the Clinical Trials Department at IBSAL.  \n\nMs. Cristina Lugones Sánchez.   \n\nPh.D. in Nursing. Researcher at IBSAL and APISAL  \n\nMs. María Fátima Macho Sánchez-Simón.   \n\nBachelor of Veterinary Medicine\, Ph.D. in Neuroscience\, Research Associate at the UICEC’s SCReN at IBSAL. \n  \nProgram: \nANNOUCEMENT_Schedule for the 2025 Course on Good Clinical Practice (GCP) \n  \nEnrollment:   \nREGISTRATION: \n(NOTE: HUS personnel not affiliated to IBSAL are advised to register through the GESTION@ training application). \nThe pre-registration deadline is Friday\, December 5\, 2025. Please register individually through our website: \nIn order to successfully complete the course and receive the relevant certificate\, it is necessary to complete 80% of the total program. \nPlease 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. \n  \nMethod of selection: \nEnrollment 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. \n  \n 
URL:https://ibsal.es/en/evento/good-clinical-practice-gcp-guidelines-2025/
LOCATION:Online
CATEGORIES:IBSAL Course
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