Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects. Compliance with GCP assures that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible. This International Conference on Harmonization (ICH) E6 Guidance provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in those jurisdictions.

Course Objectives:

This webinar will examine the basic requirements of the GCP’s and related / supporting requirements.  Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides 1) public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that 2) the clinical trial data are credible.  The objective of the ICH E6 GCP guidance is to provide a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.  The guidance was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization.  This guidance should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.  The principles established in this guidance may also be applied to other clinical investigations that may have an impact on the safety and well-being of human subjects.

We will also consider related laws and principles that complement the GCPs stated in ICH E6 that must also be addressed in any compliant clinical trial, to ensure further protection of the human trial subjects, and repeatability and reproducibility of the data generated during the trial, ensuring its scientific accuracy, the associated statistical analysis, and ultimate conclusions.  While the focus is on pharmaceuticals, much of the material is also applicable to medical devices. 

Course Outline:

Session 1:  GCP Refresher Training:

• FDA’s Guidances on Data Integrity / Cybersecurity

• 21 CFR Part 50, 54, 56, 58, …

Session 2:  ICH E6 (R2) GCP Guidance:

• IRB / IEC

• Investigator’s, Sponsor’s, Monitor’s Responsibilities

• Audits

• Protocols

• Essential Documents

What You Get:

• Training Materials

• Live Q&A Session with our Expert

• Participation Certificate

• Access to Signup Community (Optional)

• Reward Points

Who Will Benefit:

• R&D

• Risk Managers

• Engineering

• Supervisors

• Business Owners

• General Managers

• Marketing

• Company owners

• Presidents and CEO's

• Quality Assurance and Regulatory Affairs

• Managers