Good Clinical Practice (GCP) is a set of guidelines for clinical research done on human subjects. GCP serves as the international standard for designing, conducting, monitoring, documenting, analyzing, and reporting clinical trials.
In this instructor-led, live training, participants will learn the most important guidelines and fundamental principles applied in Good Clinical Practice (GCP) for clinical trials and researches involving human subjects. This course provides an overview of the different GCP areas, but provides slightly more focus on the ICH-centric GCP for Investigational Drugs and Biologics.
By the end of this training, participants will be able to:
- Understand the fundamental principles of GCP for investigational drugs and biologics as based on the International Conference on Harmonization (ICH)
- Apply the guidelines stipulated by the GCP to their clinical researches and trials
Audience
- Clinical investigators
- Clinical research professionals
- Healthcare and medical professionals
- Clinical trials support staff
- Research and development staff
Format of the course
- Part lecture, part discussion, exercises and heavy hands-on practice
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