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 training, required by the majority of European Regulators.
The course will allow professionals who are active in clinical research to understand the responsibilities of everyone involved, with practical examples which allow a direct implementation in their area of work.
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. In addition, the implementation of GCP requirements is explained and illustrated using examples from practice.
Our ICH-GCP training 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.
Course time09h00 - 17h00
Who should attend
Everyone who wants to understand the current regulations and Good Clinical Practice (GCP) in clinical studies. No prior training or working experience in a GCP environment is required.
- Principles of GCP
- Responsibilities for all involved persons
- Current legal regulations
- The essential GCP-related documents
- The most common problems & practical tips to help you avoid them
- Comprehending the basics of GCP requirements in clinical research and how they are implemented
- Understand the current legal requirements and GCP responsibilities
- To understand the essential documents of clinical studies