Good Clinical Practices Review of ICH E6 (R3) Latest Guidance

What is Good Clinical Practice?  Good Clinical Practice (GCP) is an international ethical and scientific quality standard.  The standard is intended to specify processes for the design, conduct, recordkeeping and reporting for clinical trials that involve human subjects.

The standard is used by governments to craft their clinical trial regulations. GCP follows the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces precise guidelines on the ethical aspects of clinical research.  The specific ICH standard is ICH E6.

GCP guidelines specify how the rights of human clinical trial subjects are protected. The guidelines include standards concerning how clinical trials are to be conducted, and particularly, the roles and responsibilities of institutional review board members, clinical research investigators, clinical trial sponsors, and monitors.

Clinical trials demand comprehensive documentation for the clinical protocol, recordkeeping for each aspect of the trial, and training, and facilities requirements, including software. Quality assurance and inspections ensure that these standards are met throughout the trial. GCP aims to ensure that the studies are scientifically valid and that the clinical properties of the investigational product are properly documented.

Past unsuccessful and ineffective clinical trials were the main reason for the creation of ICH and GCP guidelines in the US and Europe. These discussions ultimately led to the development of regulations and guidelines, which evolved into the code of practice for international consistency of quality research.

Why You Should Attend:

Prior to the GCP guidance document developed by the International Conference on Harmonization (ICH), many different guidelines existed for the conduct of clinical trials. With the introduction of ICH GCP, globally that conduct has become more uniform and standardized. Today, the implementation of ICH good clinical practice in most jurisdictions is reasonably similar with the vast majority of the regulations being the same.

It is imperative to conducting compliant and scientifically valid clinical trials that all personnel concerned in those trials from the physicians to clinical trial monitors fully understand the requirements of GCP.

The webinar will establish the foundation for this subject by defining GCP and discussing GCP in relation to its historical perspective.  The thirteen core principles of GCP are essential to understanding how GCP is structured and expected to be manifest in clinical trial execution.  ICH E6 will be reviewed in detail as that guideline serves as the standard for most of the regulations world-wide.  The webinar will end with a discussion of how to effectively implement the principles of ICH E6 (R3) Latest Guidance.

Areas Covered in the Session :

• Definition of Good Clinical Practice
• Provide a historical perspective on GCP
• Why do we need GCP?
• 13 core principles of GCP
• Introduction to ICH E6
• Review of ICH E6 (R3) Latest Guidance
• How to implement GCP in your organization

Who Should Attend:

• Everyone involved in clinical trials
• Quality Assurance Departments
• Regulatory affairs Departments
• Clinical safety personnel
• Clinical data management personnel
• Regulatory Inspectors
• Physicians and nurses

Course Director: CHARLES H. PAUL

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.