John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 38 years experience in U.S. FDA-regulated industries, 24 as an independent consultant. John has worked with companies from start-up to Fortune 100, world wide. He specializes in quality assuranc Read more
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.
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.
Why Should You Attend:
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. This International Conference on Harmonization (ICH) E6 Guidance on GCP 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.
• Introduction to the GCPs
• Declaration of Helsinki
• ICH E6
• IRB / IEC
• Sponsor, Investigator, Monitor Responsibilities
• Data and Reports
• Other 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:
All personnel involved in setting up and/or conducting / monitoring clinical trials.
• Product engineering
• Senior management
• Regulatory Affairs
• Quality Assurance / QAE
• Engineering, R&D, and software development and testing teams