Objectives of the Presentation
Identify the changes impacting investigator responsibilities and roles
Explain the impact of the revisions to sites and Sponsors-Investigators
Evaluate solutions for applicability/modification of organizational SOPs, processes, procedures and staff training
Apply lessons learned for effective implementation of the new ICH GCP E6 R2 guideline
Why Should you Attend
The updated ICH GCP E6 R2 is more descriptive than the previous version and describes 26 items of change. These changes consist of new items in definitions; new sections on investigator responsibilities, including oversight; a substantial new sponsor section on quality management, including risk assessment; monitoring plans defined and implemented; introducing Risk-Based Quality Management; serious breaches, and, a new section on computer validation and electronic records, to name a few. This web seminar explores the changes in detail to promote a better understanding of how they impact clinical trials.
This course is not only a comprehensive guide to ICH-GCP but the implementation of GCP requirements is explained and illustrated using real life examples.
What is ICH GCP?
Investigator Qualifications and agreements
Medical care of trial subjects
Communication with IRB/IEC
Compliance with protocol
Investigational products, randomization procedures and unblinding
Informed consent of trial subjects
Source documentation and record keeping
Progress reporting/final reports
Premature termination or suspension of trials
Who will Benefit
Quality Assurance/Compliance Personnel, Principal Investigators/Sub-Investigators, Research Site Staff (Managers, Clinical Research Coordinators, Data Managers/Data Entry)Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management, Study Managers/Project Managers, Clinical Research Associates/Monitors (Centralized, On-site, Clinical Site Selection/Management Personnel, Clinical Site Coordinators (CRCs)Clinical Research Associates/Monitors (CRAs)Clinical Trial Managers (CTMs)Data Managers, Clinical Operations & Project Management, Compliance & Regulatory Affairs, study coordinators and research nurses, other hospital staff or ancillary staff involved in a clinical trial
The revised Good Clinical Practice (GCP) guideline from the International Conference on Harmonization (ICH), known as ICH-GCP E6 (R2), has now been approved. This first update in two decades is expected to be adopted worldwide by regulatory agencies, including the FDA, EMA and Japanese Health Authority, and so brings major implications for all clinical development stakeholders.ICH-GCP E6 (R2) reflects the industry's growing emphasis on risk-based quality management, highlighting the increasing complexity of clinical trials and how the ongoing evolution in technology creates opportunity for greater efficiency in quality management. (see
full course description)