Saturday, May 15, 2010

Advanced Good Clinical Practice

What do you know about Good Clinical Practice or GCP? Here's what Wikipedia has to say about GCP:
Good Clinical Practice (GCP) is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.
If you're looking for some education and training regarding GCP, then take a look at this upcoming course where you'll learn more about GCP. Here's a brief description:

This course provides an advanced, in-depth review of the structural elements of Good Clinical Practice (GCP). Participants will learn practical application of GCP regulations and guidelines for critical components of the clinical research process. Specific attention will be given to how quality systems, or a lack thereof, impact overall data quality and regulatory risk. This program is designed for professionals with at least two years of experience in the clinical research industry.

This course is recommended for experienced Clinical Quality Assurance Professionals, Clinical Research Associates, Project Managers, Investigators, Study Coordinators, and GCP-Focused Regulatory Affairs Professionals.

Learning Objectives:
  • Develop and implement site-specific approaches for corrective action of non-compliance
  • Describe the elements of a functional Quality System
  • Define key GCP terms
  • Examine recent trends in non-compliance
  • Identify the universal and local components of GCP
  • Explain the differences between the legal and procedural elements of GCP
  • Recognize key differences in pharmaceutical, device, and biologics GCP
  • Describe the overlap between GCP and GMP
You can learn more about this Barnett Educational Services course here.

Cambridge Healthtech Institute (CHI) is the preeminent life science network for leading researchers and business experts from top pharmaceutical, biotech and academic organizations. CHI’s portfolio of products includes Cambridge Healthtech Institute Conferences, Insight Pharma Reports, Cambridge Marketing Consultants, Barnett Educational Services, Cambridge Meeting Planners and Cambridge Healthtech’s Media Group, which includes numerous e-newsletters as well as Bio-IT World magazine.

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