Overview:

A half day course relevant to Principal Investigators, Research Nurses and associated research site staff who have attended a full GCP training day within the last two 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:

• Clinical Research Governance (Revision & Updates)
• Principles of Good Clinical Practice
• Investigator Responsibilities
• Regulatory Inspections

The course has Category 1 Approval from the Nursing & Midwifery Board of Ireland (NMBI). All attendees are eligible for 2 CEUs on completion.  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 24th April 2017 & Thursday 14th September 2017

RCSI Education & Research Centre, Smurfit Building, Beaumont Hospital

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