In this GCP webinar understand The Regulatory requirements to follow to be GCP compliant for a site involved in research involving human subjects.
Areas Covered in the Seminar:- The historical background of why the GCP standards were developed.
- The concept of and the purpose of GCP .
- The twelve ICH Principles of GCP .
- The ICH definition of GCP and how it is applied.
- The Regulatory requirements to follow to be GCP compliant.
- Who, in the clinical research team is responsible that GCP is followed?
- How to be sure CPU / Site staff know their role in maintaining GCP.
Who Will Benefit:This Webinar will provide invaluable assistance to the pharmaceutical industry and to investigators and their staff in the regulatory / legal responsibilities and also the ethical considerations in pharmaceutical product (Drug or device) research involving human subjects. Those benefiting the most would be:
- Principal Investigators / Sub-investigators.
- Clinical Research Scientists (PKs, Biostatisticians,)
- Safety Nurses
- Clinical Research Associates (CRAs) and Coordinators (CRCs)
- Recruiting staff
- QA / QC auditors and staff.
- Clinical Research Data managers
