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95% of those polled in 2018 found the summit to be excellent!

Is your organization inundated with information and unable to focus on what matters?

Does your staff struggle with analytical, critical thinking skills needed to manage risk and uncover opportunities to drive real change?

Come to the Clinical Trial Risk and Performance Management Summit and discover the secrets to implementing a successful metrics program. You’ll unlock the secrets to deciding what to measure; establishing your data requirements; aggregating reliable data; designing easy to understand metric reports; and using metrics to identify areas of concern and conduct root cause analysis.

Check out this sampling of what you’ll explore over the course of an information-packed day-and-a-half:

ICH-E6(R2): This international guideline continues to challenge contract research organizations, sponsors and others. How do regulators use data to determine where to conduct inspections? What challenges has risk-based quality management presented to others? How should you address such challenges? Get ready for answers — from FDA, MHRA and EMA officials as well as industry top thinkers.

Squeezing Max Value Out of Data: Do your metrics answer the high-priority questions, reward the right behaviors, give you reliable time/quality readings? Speakers and panelists are ready with answers.

Data Quality: Designing data reports end-users can read and understand… aggregating in-house and CRO/vendor data… data governance and stewardship… and much more.

Predictive Analytics: Predictive analytics can help you with site selection, quality indicators and more. Discover savvy new ways to apply and test findings.
Critical Thinking Skills: Staff can be the weakest link. Discover creative new ways to move away from a ‘check the box’ mentality.

Join us at the Clinical Trial Risk and Performance Management Summit to explore how you can address these challenges.

Network and problem solve with your peers by choosing one of two tracks, vendor oversight and risk-based quality management.

Announcing the 14th Annual FDA Inspections Summit: far and away the number one event for quality, compliance and regulatory professionals.

Over the course of two-and-a-half days, you’ll receive vital information from current and former FDA officials and industry experts aiming at your inspectional readiness.

Choose from three different tracks — Drugs & BiologicsMedical Devices and Clinical Trials— to guarantee your comfort with the tools and tactics you’ll need to apply on the job.

The pre-conference workshops options on Oct. 23 are:

On Oct. 24, day one, you’ll hear how to create a world-class quality culture, attend a panel discussion on the 10 best and 10 worst things to do when FDA staff are on site and gain focus through an extraordinarily helpful interactive exercise — a mock inspection. During the day’s three breakout tracks, you can choose:

On Oct. 25, day two, you’ll get inspection-ready through covering:

The summit’s agenda, presentations and panel discussions are simply unmatched. Ensure successful inspections each time. This best-in-class summit is key.

DHRHealth Institute for Research and Development
5323 S. McColl Rd., Edinburg, TX 78539
(956) 362-2390
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