Description

Clinical Operations Courses
Part of a STAR Programme

You are a professional within clinical research; investigator, monitor or other staff; then you need to comply with the Good Clinical Practice guideline. This one-day course will give you the needed ICH-GCP training, required by the majority of European Regulators.

The course will allow professionals who are active in clinical research to fully understand the requirements and responsibilities of everyone involved in clinical research.

Without training on the International Conference on Harmonization Good Clinical Practice (ICH-GCP) standards, or without experience in clinical research, professionals are not always aware of the legal regulations that govern clinical studies, including post-marketing trials. ICH-GCP is the guideline ruling all clinical research including its conduct, performance, monitoring and reporting of the results. This course focuses on the requirements of Good Clinical Practice (GCP) in clinical studies with pharmaceuticals. The complete and most recent version of the ICH-GCP is covered by this training, including the Addendum of 2016. All elements of the addendum, such as risk-based quality management and supervision will be presented. In addition, implementation of GCP requirements is explained and illustrated using examples from practice.

Furthermore, our ICH-GCP training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training Identified by TransCelerate BioPharma, as requested for mutual recognition of GCP training among trial sponsors.

Course time
09h00 - 17h00
Who should attend

Everyone who wants to understand the current Good Clinical Practice (GCP) requirements for clinical studies. No prior training or working experience in a GCP environment is required.

Programme highlights
  • Clinical Research and Regulations
  • ICH-GCP definitions and Principles
  • ICH-GCP Responsibilities of Ethics Committees/ Investigators/ Sponsors/Monitors
  • The Protocol, Investigator’s Brochure and other Essential Trial Documents
  • The GCP-Addendum of 2016
  • Common GCP non-compliance
Learning Objectives
  • Fully grasp the GCP requirements for conduct and documentation of clinical studies
  • Distinguish the responsibilities of all involved parties
  • Understand the regulatory requirements imposed by GCP
  • Recognise common problems and obtain insight to avoid errors

Book a course

Date Lang Location
 
Proceeding your application may take up to 24 working hours. In case of question, contact campus@eccrt.com.
800,00 € excl. VAT (if applicable)

Testimonials

Anja Hijzen
August 2017
Company
Janssen Pharmaceutica

A really good one-day course which gives you all you need to know, really to the point and useable right away. - Great teacher! The course was very interactive and I was a bit scared to be bored but I was not.