Webinar: Good Clinical Practices and Good Laboratory Practices - What You Must Know and Do 

Good Clinical Practices and Good Laboratory Practices Course Description

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. GLPs support GCPs.

Why Should You Attend

This webinar will examine the basic requirements of the GLPs and 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. The use of GLPs (Good Laboratory Practices support the safety and accuracy of the GCP-generated data. 

Webinar Takeaway

• Introduction to the GCPs / GLPs
• Declaration of Helsinki 
• IRB / IEC
• Sponsor, Investigator, Monitor Responsibilities
• Laboratory Responsibilities
• Protocols
• Audits
• Data and Reports
• Other Essential Documents

Who Will Benefit

All personnel involved in setting up and/or conducting /monitoring clinical trials.

• Marketing
• Product engineering
• Senior management
• Regulatory Affairs
• Quality Assurance / QAE
• Production
• Engineering, R&D, and software development and testing teams
  

Background

The objective of the 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 Good Laboratory Practice regulations describe the minimal standards for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by FDA or EPA such as animal food additives, human and animal drugs, medical devices for human use, biological products, electronic products, or pesticide products. The regulations do not pertain to studies utilizing human subjects or clinical studies for which the current Good Clinical Practice (cGCP) standards would apply, although they support the GCPs.

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.