JOIN WITH US FOR LIVE WEBINAR - "Risk Management in Clinical Trials: The New ICH E6 Focus"

Live Webinar: Risk Management in Clinical Trials: The New ICH E6 Focus When: Thursday September 2, 2021 - 01:00 PM Duration: 90 Minutes.

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Revision 2 of ICH E6 emphasizes a risk-based approach to managing clinical trials, especially those that rely heavily on electronic data systems and software. “As our clinical trials have continued to become more complicated with the increase in technology” — states our course Instructor— “we strive to be more efficient. With this can come more risk.”

In Risk Management in Clinical Trials this webinar explains the significance of the new focus on risk management and the benefits it can reap including:
Directing the sponsor’s limited resources to higher risk areas, resulting in better overall quality
Focusing more on prevention than on the traditional monitoring approach (process improvement vs. quality control)

It offers recommendations for implementing new requirements, including:
Implementing a quality management system that covers all stages of the trial process
Identifying critical processes and key data
Adopting principles of risk management — identification, evaluation, control, communication and review
Meeting centralized monitoring requirements
Validating electronic data processing systems
How to address noncompliance that has the potential to significantly affect human subject protection or reliability of trial results