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ExL’s 10th Proactive GCP Compliance

March 18-20, 2019  |  The Inn at Penn  |  Philadelphia, PA

Now in its tenth year, ExL’s Proactive GCP Compliance conference continues to act as the annual forum for both senior-level clinical quality and clinical operations executives to gather, learn and discuss strategies to achieve and maintain global GCP compliance. Join us to learn how to effectively build quality risk management approaches into your clinical operations to optimize research, maintain GCP compliance, contain costs and ensure patient safety. Learn more >>

Receive a 15% discount off the standard pricing with code 786019AVOCA


Join Avoca for the following session:





Wednesday, March 20 | 8:45am – 9:30am

RISK REVIEW AND REPORTING (ICH E6 (R2) 5.0.6 & 5.0.7): Conduct Continual Review of Risk Control Measures for Needed Adjustments and Effectively Report Any Changes

Steve Whittaker, Senior Consultant, The Avoca Group

  • Recognize that effective risk management requires continual review
  • Review and mitigate anticipated risks by taking actions that may prevent reaching control limits
  • Conduct continual review of risk control measures for needed adjustments and effectively report any changes
  • Take into account emerging knowledge and experience to adjust quality tolerance limits and risk control measures to ensure they remain effective and relevant
  • Document any deviations from original quality tolerance limits to explain implications and/or justify the subsequent adjustments

To schedule a meeting with an Avoca representative at this event, contact us.