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 & Biologics, Medical 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:

• Flawless FDA Inspection Handling and Response (Drugs & Biologics Track) — Discover how to manage FDA investigators on-site, how to defend yourself where appropriate and craft 483 responses that fend off warning letters
• Process Validation for Medical Devices: Preparing for a QSR Inspection (Medical Devices Track) — Understand the fundamental requirements of medical device process validation, analyze warning letters so you can apply lessons learned and gain clarity on what you need to do, when to do it and what records to keep
• ICH E6(R2): How to Be Inspection Ready with Your Sponsor Risk Management Program (Clinical Trials Track) — Gain insight into what you must do to comply with the challenges inherent in the recent ICH E6(R2) guidelines with this hands-on, interactive training

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:

• Drugs & Biologics Track
  • Concept of Operations: How Integration of the FDA Facility Evaluation and Inspection Program Impacts Your Organizations
  • Today’s Track & Trace: What Merck and the FDA Have Learned
  • Panel Discussion: The US/EU Mutual Recognition Agreement (MRA) for Drug GMP Inspections
• Medical Devices Track
  • FDA’s Shift from QSR to ISO 13485:2016: A Significant Change for Inspections
  • Preparing for a MDSAP Audit: A Case Study from the Manufacturer’s Perspective
  • Panel Discussion: EU-MDR: Final Push for Compliance by the May 26, 2020 Deadline
• Clinical Trials Track
  • Meeting CRO-Vendor Oversight Requirements
  • Validating Your Systems and Equipment for Compliance
  • Quality by Design — Build Quality into Clinical Trials to Proactively Identify and Mitigate Risks

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

• The latest patterns in FDA’s 483s and warning letters, so you can pass your next inspections easily
• Good techniques for data organization and how to create effective new SOPs for electronic document management
• New developments in FDA’s field operations reorganization and program alignment; how this will impact your inspections?

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