What are the “Good Clinical Practices” (GCP) of Research involving Human Subjects

September 21, 2010(Ended)
Online Webinar
What are the “Good Clinical Practices” (GCP) of Research involving Human SubjectsIn 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
Prices *
199 US Dollar
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* Prices are for evaluation only.