Good Clinical Practice is an international set of regulations, which comprise a quality system responsible for ensuring the safeguarding of subjects’ health and human rights in clinical trials involving Investigational Medicinal Products (IMP’s), as well as the efficacy of these IMP’s.
GCP guidelines have been constructed by the International Conference on Harmonisation and provide a framework for the conduct of clinical trials and define the roles of all parties involved – investigators, sponsors, CRA’s, etc.
Please see below all the GCP training related topics that Astra Nova can deliver anywhere in the World, thorough the International Network of Trainers. The GCP course of your choice could be delivered to you as an in-house training solution, right at your office, or venue of preference or as a webinar session for small and large groups.
Good Clinical Practice (GCP) Training Topics
- Introduction to GCP
- Monitoring and Auditing Clinical Laboratories
- GCP Compliance for Monitors
- Advanced Quality Assurance
- GCP for Investigators
- GCP for Monitors
- GCP for site staff
- Overview UK GCP (local legislation specifics)
- GCP Refresher
- Clinical Trial Directive
- GCP for Pharmacovigilance staff
- Safety Reporting
- Clinical Trial Protocol
- Advanced GCP
- GCP for Medical Devices companies
- Informed Consent
- Serious breach and ‘non-compliance’ considerations
- GCP compliance, SOPs and Quality Management Systems
If you do not see the Good Clinical Practice training that you were looking for, please contact us for a quote on a custom GCP in-house course or GCP webinar.