Did you know that your clinical investigations need to comply with the Good Clinical Practice (GCP) guideline?
This one-day course is crucial for any professional in the field of clinical research. It will provide you with all elements of the International Council on Harmonization Good Clinical Practice (ICH-GCP) guideline E6 (R2), as required by the majority of Regulatory Authorities.
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.
This course covers all eight chapters of the ICH-GCP in its current version and will cover the responsibilities of every stakeholder involved, as well as its implementation in practice.
Without training on the ICH-GCP requirements, 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 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.