Overview:  

A one day course aimed at investigators, project managers and associated research team members involved in investigator-led clinical trials, representatives from the pharmaceutical industry and research officers from academic institutions. This course incorporates the Integrated Addendum to ICH GCP Guideline E6 (R2) adopted by the EMA in December 2016.

The following content is included:

Ø  Clinical Research Governance: Background, Rules and Regulations

Ø  Principles of Good Clinical Practice

Ø  Sponsor Responsibilities

Ø  Regulatory Inspections (Sponsor Perspective)

Monday 8^th May 2017

RCSI Education & Research Centre, Smurfit Building, Beaumont Hospital

Please contact either:

Deirdre Hyland: Director of Research Nurse Education (01) 809 3785 dhyland@rcsi.ie or

Carole Schilling: Quality & Regulatory Affairs Manager  (01) 809 3789 caroleschilling@rcsi.ie