Good Clinical Practice on Sponsor Responsibilities – 8 May 2017

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Good Clinical Practice on Sponsor Responsibilities – 8 May 2017

RCSI Training event

Overview

RCSIThis is 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. The 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: Background, Rules and Regulations
  • Principles of Good Clinical Practice
  • Sponsor Responsibilities
  • Regulatory Inspections (Sponsor Perspective)

Cost: €100 for attendees from academic institutions and €300 for industry attendees.

Date: Monday 8 May 2017.

Venue: Smurfit Building, Beaumont Hospital Dublin 9.

Registration: Please contact Deirdre Hyland or Carole Schilling confirming which study day you wish to attend.
Deirdre Hyland: Senior Research Nurse/Director of Research Nurse Education, (01) 809 3785.
Carole Schilling: Quality & Regulatory Affairs Manager,  (01) 809 3789.

Smurfit Building 2