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Webinar: Risk-Based Monitoring Implementation – What does ICH E6 Rev2 Mean for My Company?

By January 27, 2017March 9th, 20222 Comments

With the official publication of the long awaited revision of the ICH E6 Guidelines, now is the time to take advantage of the new information to ensure appropriate consideration of risk in study design and management.

For this webinar, CluePoints is again teaming up with Paragon Solutions, to highlight the key changes in the mandate and explain how best to address these elements for successful Risk-Based Monitoring Implementation.

Expect to Learn;

  • Understanding the key ICH E6 updates related to Risk-Based Monitoring/Data Quality Oversight and their purpose
  • Understanding how Central Statistical Monitoring (CSM) and Key Risk Indicators(KRIs) will work for you
  • Critical-to-success methods for Central Statistical Monitoring and KRIs
  • Change Management – Using E6 R2 to support your organization’s transition to RBM
  • The Monitoring plan – not just for monitoring intervals anymore

When?

This webinar has ended – you can watch the recording on-demand here

Patrick Hughes

Patrick holds a Marketing degree from the University of Newcastle-upon-Tyne, UK, and a post-graduate Marketing diploma in Business-to-Business Marketing Strategy from Northwestern University - Kellogg School of Management, Chicago, Illinois. Responsible for leading global sales, product, marketing, operational and technical teams throughout his career, Patrick is a Senior Executive with over eighteen years international commercial experience within life sciences, healthcare and telecommunications. In the past, Patrick consulted on corporate and commercial strategy for various life sciences companies and was responsible for successfully positioning ClinPhone as the leading Clinical Technology Organization during his 10-year tenure with the company.

2 Comments

  • Kevin Wightman says:

    Hi Pat. I hope all is well with you? Will a recording be available for this webinar?

    Cheers
    Kevin

    • Gemma Telfer says:

      Hello Kevin,

      All is well at this end, thank you. Hope you’re well too!

      If you register for the webinar, we’ll automatically send you a link to the recording in the days following the event.

      Thanks!
      Gemma/Pat.