In this GCP webinar understand The Regulatory requirements to follow to be GCP compliant for a site involved in research involving human subjects.
Why Should You Attend:
GCP governs or sets the standard for all aspects of clinical research including ethical aspects, operational responsibilities, documentation and management of the data collected and most importantly all aspects of subject safety from the informed consent process through to the handling of Adverse Events.
Both the FDA and the DHHS regulations are designed to ensure that the rights and welfare of human subjects (normal healthy volunteers, patients and especially the vulnerable) is protected. At the same time the integrity and validity of the data generated gives the regulators confidence of both the safety and efficacy of the drug of device being tested. The 9 “Commitments” on the FDA Form 1572 serve as a guide to how “GCP” is viewed by the Regulatory Authorities.
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
For More Information: