12:00 PM - 3:00 PM Eastern
For the first time in 20 years, the International Conference for Harmonization (ICH) Good Clinical Practice (GCP) E-6 Guideline is being updated. The proposed revisions are intended to modernize and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, documentation, and reporting, as well as human subject protections. But, the proposed changes have resounding effects and impact on sponsors/CROs and investigators, requiring a complete and systematic analysis to ensure adherence to these proposed clinical trial standards. This web seminar reviews the proposed changes, the varied, select, clinical research practices impacted and select approaches to use when addressing the new requirements (e.g., standards, processes, procedures, training, documentation) that serve both as the starting point for an organization’s gap analysis, and, the subsequent re-design of work practices for compliance with the ICH GCP E6 R2 proposed revisions. In addition, an overview of key points to include in an organization’s project plan/implementation plan for the proposed revisions will be presented with time allocated for Q & A and discussion.
BONUS reference slides are provided on: Organizational quality management systems, quality, quality in the clinical trial context, risk definition, risk management framework benchmark (ISO 31000 model), and a list of industry think tanks that provide free information, training materials, methods and tools for the industry’s use since, due to time limitations, these topics are not able to be addressed. Barnett does provide training on these topics as distinct courses that are provided on-site or via web seminar that allows for a confidential discussion on your specific needs during the training.