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.
This course has been reviewed by the Belgian GCP Inspectorate.
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.
This ICH-GCP training is equally recognised by the Swiss Association of Ethics Committees for clinical trials as training for investigators and sub-investigators of clinical trials in Switzerland.
Without training on the International Conference on Harmonization Good Clinical Practice (ICH-GCP) standard, 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 all 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 all chapters with the integrated Addendum of 2016. All elements of the addendum, such as risk-based quality management and supervision, validation of computerised systems, etc. will be presented.
The implementation of GCP requirements is explained and illustrated using examples from practice.
Interactive workshops (brainstorm, group discussion) and exercises for self-assessment (quiz and cases) are included to provide a better understanding of each part of the course.
Course time09h00 - 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.
- Clinical Research and Regulations
- Highlights of the Declaration of Helsinki
- ICH-GCP Definitions and Principles
- ICH-GCP Responsibilities of Ethics Committees/ Investigators/ Sponsors/Monitors
- The Protocol, Investigator’s Brochure and other Essential Trial Documents
- ICH-GCP non-compliance
- 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
- Be prepared to implement GCP requirements in your clinical research activities
- Understand the impact of the ICH-GCP E6 (R2) Addendum 2016
- Recognise common problems and obtain insight to avoid errors