The GCPs: How to Implement for Compliant Clinical Trials

Description

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.

Areas Covered in the Webinar:

• Introduction to the GCPs
• Declaration of Helsinki
• ICH E6
• IRB / IEC
• Sponsor, Investigator, Monitor 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

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has ptublished numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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