A Good Clinical Practice course will be held in the Education and Research Centre, Beaumont Hospital, on Thursday 13th July , 09.00 – 16.00.
Essential training for Principal Investigators, research nurses/midwives, monitors and research site personnel involved in clinical trials of medicines.
Content is based on ICH E6 (R2) 2016, and includes key requirements of the Clinical Trial Regulation (536/2014), and includes
· Introduction to Drug Development and Clinical Research
· Clinical Research Governance & Principles of Good Clinical Practice
· Investigator Responsibilities
· Safety Reporting, Essential Documents & Regulatory Inspection
To reserve a place please contact Deirdre Hyland: email@example.com
See the agenda here
The course is accredited by the Nursing & Midwifery Board of Ireland (NMBI). It also meets the minimum criteria for ICH GCP investigator site personnel training identified by TransCelerate Biopharma as necessary to enable mutual recognition of GCP training by trial sponsors