Overview

This one day course is relevant to Principal Investigators, research nurses and associated research site personnel who have not undertaken GCP training within the previous 2 years. This course incorporates the Integrated Addendum to ICH GCP Guideline E6 (R2) adopted by the EMA in December 2016.

The following content is included:

• Introduction to Drug Development and Clinical Research
• Research Ethics and Clinical Research Governance
• Principles of Good Clinical Practice
• Investigator Responsibilities
• Regulatory Inspection

The course has Category 1 Approval from the Nursing & Midwifery Board of Ireland (NMBI) – 6 CEUs. 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 among trial sponsors

Monday 13th February 2017 & Thursday 20th July 2017.

RCSI Education & Research Centre, Smurfit Building, Beaumont Hospital

Thursday 23rd November 2017, RCSI, St Stephens Green, Dublin 2

Additional training dates can be facilitated at alternative locations for groups of 10 or more.

Please contact Deirdre Hyland: Director of Research Nurse Education

(01) 809 3785 dhyland@rcsi.ie