By using an original approach based on extensive feedback from experience, this training course aims to satisfy the following objectives in the specific context of Good Clinical Practice:
- Understand the regulatory requirements of Good Clinical Practices (GCP), in a national and international context (or “Why and when GCPs must be implemented”).
- Understand the ethical requirements: definition of ethics, the underlying principle of clinical tests. What are the practical consequences? Learn ethical requirements at national and international levels. Learn how to protect the volunteer (health, protection of privacy (personal data, confidentiality) etc.)
- Understand the key functions in GCP organisation: The role of the investigator, promoter, monitor.
- Learn how to set up a clinical study and how to ensure that GCPs are complied with, that the data are efficiently collected, etc.
Training Agenda:
- Key aspects of clinical research
- Clinical plan and study design
- Types of clinical studies (pilot, pivotal, post-marketing)
- Subjects/patients enrolment
- Quality Assurance / Quality Control /Monitoring
- Quality Assurance approach and Monitoring / procedures to be implemented / frequencies of audits/types of audits, control of source data, CRF, respect of inclusion criteria, etc.
- Quality System (QS) regulations
- Adverse Events: Definition, identification, documentation, reporting and follow-up
Who should attend?
This ICH Good Clinical Practice training course is specifically designed for those professionals who need basic and in-depth knowledge in ICH GCP requirements and legislation. The objective is to create awareness and provide advice on the practical issues of GCP as well as to get a better understanding of the regulatory requirements and to raise awareness on possible problem areas.
The training is suitable for:
- Clinical research professionals in the pharmaceutical and biopharmaceutical
- industry, clinical research organizations, and research institutions.
- Investigators
- Clinical Trials Support Staff (e.g staff working in CROs)
- Clinical Research Asociates
- Clinical Research Coordinators
- Clinical Research Management Staff (Project Managers , Medical Directors, , etc)
- Graduates looking to develop a career in clinical research
- Everyone who is interested in networking with other clinical research professionals
Fee:
49 EUR
Register for another webinar and get 10% discount
Date of Session:
To be confirmed
Technical Information:
Session will be conducted on-line via a web meeting. Each participant will receive a unique user ID and login to access the session.
