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Webinar: ICH E6 (R2) Risk-Based Requirements: Beyond Just Risk Planning to Actual Success in Risk Review and Control

Recorded Wednesday, February 13, 2019  |  11:00am – 12:00pm EST

Risk planning for clinical trials, as required by ICH E6 (R2), is becoming common practice within the industry. However, risk planning is only the initial, though simplest, step in successfully mitigating issues, and meeting regulatory compliance and desired quality. ICH E6 (R2) describes a more comprehensive risk-based approach that includes risk identification, evaluation, review, control, communication, and reporting with ultimate documentation and process improvement. It is only when all of these factors are implemented successfully that benefits will be optimally achieved for patient safety and the integrity of reported clinical trial results.

This session shared leading practices for a comprehensive risk-based approach that will enable clinical study teams to be efficient, yet effective, in not only planning risk assessments, but in implementing and living in an ongoing, risk-based culture that benefits all stakeholder groups (sponsor companies, provider organizations, investigative sites, and regulators) through the minimization of active, high-resource consuming issues.

Key learning objectives:

  • Processes for continual risk review and risk control measures
  • Effectiveness of continual risk review and risk control measures
  • Emerging knowledge and experience to establish metric thresholds and quality tolerance limits (QTLs) and then apply risk control measures to ensure they remain effective and relevant
  • QTL adjustments in instances when it is appropriate
  • Documentation of deviations from original quality tolerance limits to justify the subsequent adjustments


This webinar is suited for:

Good Clinical Practice (or clinically focused) leaders, such as:

  • ​​Quality Assurance and Clinical Operations Professionals:  VPs, Executive Directors, Directors, Managers
  • Functional Managers and Directors for Data Management, Biostatistics, Pharmacovigilance, Drug Safety, Medical Affairs, Regulatory Affairs
  • Centralized or Center of Excellence Roles for Risk Planning and Control



Steve Whittaker

Senior Consultant, The Avoca Group


Hosted by: ExL Events