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

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
  • Start:September 02, 2021
  • End:September 02, 2021
  • Recurring
  • Where:New York, New York,, Not found, Not found, Not found, 10000
  • Phone:N/A
  • Event Type: Other
  • Ticket Price:N/A
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